A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01077622

Enrollment

Registered

2010-03-01

Start date

2009-09-01

Completion date

2011-04-01

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukaemia, Lymphocytic, Chronic

Brief summary

Ofatumumab is an IgG1κ fully human monoclonal antibody (mAb) that specifically recognizes an epitope on the human differentiation antigen CD20 molecule. In vitro and in vivo studies demonstrated that ofatumumab depletes CD20 positive (CD20+) B cells through complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC), which results in the antitumour effect. This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in chronic lymphocytic leukemia (CLL) patients. Ofatumumab will be administered intravenously at the first dose of 300mg followed by 7 weekly infusions of 2000mg, followed by 4 infusions of 2000mg at every 4 weeks. Primary objective of the study (Part A) is to evaluate tolerability, and the study (Part B) is to assess overall response rate in CLL population. 10 subjects will be enrolled into this study. Subjects will be followed for 48 weeks.

Detailed description

Interventions

DRUGofatumumab 100 mg, 1000 mg / vial

ofatumumab , 300mg followed by 7 weekly infusions 2000 mg, followed by 4 monthly infusions 2000mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects eligible for enrolment in the study must meet all of the following criteria at the time of screening: * Patients who gave consent to this study participation and signed into informed consent form. * Previously treated(Patients who received at least one prior CLL therapy and have either relapsed or have refractory disease, both requiring therapy.) CLL with at least 5 x 109 B lymphocytes/ L (5000/μL). The diagnosis of CLL requires CD5, CD19, CD20 and CD23 positivity, according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines \[Hallek, 2008\]. * Laboratory test values meet the following criteria which indicate that patients have sufficient physiological functions; Neutrophils:1≥ 500 /mm3 ALT ≤ 2.5 times upper local normal limit Creatinine ≤ 1.5 times upper local normal limit Total bilirubin≤ 1.5 times upper local normal limit 1:Patients should not receive any hematopoietic cytokine such as G-CSF preparations within 1 week before screening laboratory test for neutrophil counting. \- Patients who passed the following periods from the last anti-cancer treatments at the time of screening: At least 4 weeks after anti-cancer chemotherapy. At least 4 weeks after anti-cancer radiotherapy. At least 4 weeks after glucocorticoids treatment for CLL unless ≤ 10 mg of prednisolone /day. At least 12 weeks after radio-immunotherapy and/or antibody therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2. * Life expectancy more than 24 weeks after screening test. * Aged ≥ 20 (at the time of signing informed consent). * Patients possible to stay at the trial site for at least two days (the day of the first infusion and a subsequent day).

Exclusion criteria

A subject will not be eligible for inclusion in this study if any of the following criteria is met: * Active malignancy which needs therapy with anti-cancer drug, except for CLL. * Known Richter's transformation. * Previous autologous stem cell transplantation, within 24 weeks prior to screening. * Previous allogenic stem cell transplantation. * Known CNS involvement. * History of significant cerebrovascular disease. * Current cardiac disease requiring medical treatment (e.g. atrial flutter treated with acetylsalicylic acid and beta blocking agents). * Chronic or active infectious disease requiring systemic (intravenous or oral) treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis. * Suspected/known immediate or delayed hypersensitivity to components of ofatumumab. * Patients previously treated with ofatumumab. * Positive serology test for any of HBsAg, anti-HBcAb or anti-HCVAb. If only anti-HBcAb results is positive, HBV-DNA test will be performed. If HBV-DNA results in negative, the patient is eligible. * HIV positivity. * Pregnant or lactating women. * Women of childbearing potential not willing to use adequate contraception during the study and one year after the last dose of ofatumumab, and male patients not willing to use adequate contraception during the study. Adequate contraception is defined as follows but not limited to; Abstinence. Oral Contraceptive (exclude oral progesterone alone). Intrauterine device (IUD) or intrauterine system (IUS). Male partner sterilization. Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (gel / film) etc. * Use of an investigational drug within 4 weeks prior to screening. * Current participation in any other clinical study. * Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease. * Patients who an investigator (or sub investigator) judges ineligible to this study. Note; Child-bearing potential: a woman with functioning ovaries and uterine, or no documented sterility (i.e., a woman with functioning ovaries who have a current documented tubal ligation, women who have had a hysterectomy, women who are post-menopausal, or women who have had both ovaries surgically removed).

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator	Up to Week 48	Par. were evaluated in accordance with the National Cancer Institute-sponsored Working Group. CR: no lymphadenopathy (Ly)/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils \>=1.5\10\^9/liter (L), platelets \>100\10\^9/L, hemoglobin \>11.0 grams/deciliter, lymphocytes (LC) \<4.0\*10\^9/L, bone marrow (BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to chronic lymphocytic leukemia but related to drug toxicity. PR: \>=50% decrease in LC, Ly, size of liver and spleen, etc. nPR: nodules in BM.
Number of Participants With a Dose-limiting Toxicity (DLT)	Up to Week 8	A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) \>=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as \>= G3 until the next day); and any of following: \>= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).

Secondary

Measure	Time frame	Description
Duration of Response as Assessed by a SERC	Up to Week 48	Duration of response is defined as the time from the first documented evidence of PR or better until the first documented sign of PD or death due to any reason in participants with PR or better.
Overall Survival	Up to Week 48	Overall survival is defined as the time from the first infusion of investigational drug to death due to any cause.
Time to Response as Assessed by a SERC	Up to Week 48	Time to response is defined as the time from the first infusion of investigational drug to the first response (PR or better).
Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC	Up to Week 48	Time to next CLL therapy is defined as the time from the first infusion of investigational drug to the first administration of the next CLL treatment. CLL therapy includes anti-cancer chemotherapy, anti-cancer radiotherapy, radio-immunotherapy, and antibody therapy.
Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48	Blood samples of the participants were collected for the assessment of hemoglobin.
Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48	Blood samples of the participants were collected for the assessment of lymphocytes.
Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator	Weeks 8, 16, 24, 36, and 48	Bone marrow (BM) aspiration was performed, and the bone marrow smears were prepared for the assessment of lymphocytes in the BM.
Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48	Blood samples of the participants were collected for the assessment of total neutrophils.
Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48	Blood samples of the participants were collected for the assessment of platelets.
Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC	Weeks 8, 16, 24, 36, and 48	SERC assessed bone marrow infiltration with the bone marrow smears of participants provided by trial sites.
Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC	Weeks 8, 16, 24, 36, and 48	SERC assessed lymphocytes based on the data provided by trial sites.
Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC	Weeks 8, 16, 24, 36, and 48	SERC assessed lymphocytes in the bone marrow (BM) based on the data with BM smears provided by trial sites.
Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC	Weeks 8, 16, 24, 36, and 48	SERC assessed total neutrophils based on the data provided by trial sites.
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48	CD19+ CD20+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Number of Peripheral Blood CD20+ CD23+ Cells	Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48	CD20+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Number of Peripheral Blood CD19+ CD23+ Cells	Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48	CD19+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Number of Peripheral Blood CD19+ CD5+ Cells	Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48	CD19+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Number of Peripheral Blood CD20+ CD5+ Cells	Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48	CD20+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Number of Peripheral Blood CD23+ CD5+ Cells	Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48	CD23+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48	Peripheral blood Ig kappa and Ig lambda were measured using flow cytometry. Abnormality of a ratio of Ig kappa and Ig lambda indicates clonality of lymphocytes. A normal range of this parameter is between 1.0 and 3.2.
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48	Night sweats are one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had night sweats at BL, and still had night sweats at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had night sweats at BL, but did not have night sweats at Week 1 are represented in the BL, yes; Week 1, no category.
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48	Weight loss is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had weight loss at BL, and still had weight loss at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had weight loss at BL, but did not have weight loss at Week 1 are represented in the BL, yes; Week 1, no category.
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48	Fever is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had fever at BL, and still had fever at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had fever at BL, but did not have fever at Week 1 are represented in the BL, yes; Week 1, no category.
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48	Extreme fatigue is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had extreme fatigue at BL, and still had extreme fatigue at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had extreme fatigue at BL, but did not have extreme fatigue at Week 1 are represented in the BL, yes; Week 1, no category.
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	Baseline and Weeks 8, 24, and 48	Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.
Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48	Screening; Weeks 24 and 48	HAHA are indicators of immunogenicity to ofatumumab.
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48	ECOG PS is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. The grades for the scale range from 0 (fully active) to 4 (completely disabled), with increasing severity.
Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab	Day 1; Weeks 7 and 24	Blood sampling on Day 1 and at Weeks 7 and 24 for pharmacokinetic (PK) evaluation was performed at the following time points: 0.5 hour (hr) before infusion; end of infusion; and 10 minutes (min), 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Minimum Plasma Concentration (Cmin) of Ofatumumab	Weeks 7 and 24	Blood sampling at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.
Time to Reach Cmax (Tmax) Following Ofatumumab Administration	Day 1; Weeks 7 and 24	Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Half-life (t1/2) of Ofatumumab	Day 1; Weeks 7 and 24	t1/2 of ofatumumab is the time required for the plasma concentration of ofatumumab to decrease by half. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab	Day 1; Weeks 7 and 24	AUC(0-t) was evaluated from the plasma concentration versus time curve from time zero to the last measurable time point (time t). Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7	Week 7	Blood sampling at Week 7 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.
Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24	Week 24	Blood sampling at Week 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab	Day 1; Weeks 7 and 24	Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab	Day 1; Weeks 7 and 24	Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Volume of Distribution at Steady State (Vss) for Ofatumumab	Day 1; Weeks 7 and 24	Vss for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body in equilibrium conditions to steady-state plasma concentrations. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Mean Residence Time (MRTinf) of Ofatumumab	Day 1; Weeks 7 and 24	MRTinf is the average amount of time that ofatumumab spends in the body. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Clearance (CL) of Ofatumumab From Plasma	Day 1; Weeks 7 and 24	CL of ofatumumab from plasma of participants was evaluated. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Progression-free Survival (PFS) as Assessed by a SERC	Up to Week 48	PFS is defined as the time from the start of treatment to the first documented sign of progressive disease (PD) or death due to any cause (whichever occurs earlier).

Other

Measure	Time frame	Description
Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50	Weeks 36 and 48	The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it's is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation.

Countries

Japan, South Korea

Participant flow

Participants by arm

Arm	Count
Ofatumumab Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.	10
Total	10

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Physician Decision	2
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Ofatumumab
Age, Continuous	66.3 Years STANDARD_DEVIATION 5.87
Race/Ethnicity, Customized Asian - East Asian Heritage	1 participants
Race/Ethnicity, Customized Asian - Japanese Heritage	9 participants
Sex: Female, Male Female	3 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	10 / 10
serious Total, serious adverse events	1 / 10

Outcome results

Primary

Number of Participants With a Dose-limiting Toxicity (DLT)

A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) \>=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as \>= G3 until the next day); and any of following: \>= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).

Time frame: Up to Week 8

Population: All Subjects Population: all participants who received at least one dose of investigational drug. The first 3 participants enrolled in the study were evaluated for DLT according to study design.

Arm	Measure	Value (NUMBER)
Ofatumumab	Number of Participants With a Dose-limiting Toxicity (DLT)	0 participants

Primary

Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator

Par. were evaluated in accordance with the National Cancer Institute-sponsored Working Group. CR: no lymphadenopathy (Ly)/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils \>=1.5\*10\^9/liter (L), platelets \>100\*10\^9/L, hemoglobin \>11.0 grams/deciliter, lymphocytes (LC) \<4.0\*10\^9/L, bone marrow (BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to chronic lymphocytic leukemia but related to drug toxicity. PR: \>=50% decrease in LC, Ly, size of liver and spleen, etc. nPR: nodules in BM.

Time frame: Up to Week 48

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator	SERC	70 Percentage of participants
Ofatumumab	Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator	Investigator	70 Percentage of participants

95% CI: [34.8, 93.3]

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7

Blood sampling at Week 7 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Week 7

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)
Ofatumumab	Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7	200181.8 hr*mcg/mL

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24

Blood sampling at Week 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Week 24

Population: PK Parameter Population. Only participants contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Value (GEOMETRIC_MEAN)
Ofatumumab	Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24	216678.1 hr*mcg/mL

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab

Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Day 1; Weeks 7 and 24

Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Ofatumumab	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab	Day 1, n=8	1506.3 hr*mcg/mL
Ofatumumab	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab	Week 7, n=8	716924.6 hr*mcg/mL
Ofatumumab	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab	Week 24, n=7	302326.7 hr*mcg/mL

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab

AUC(0-t) was evaluated from the plasma concentration versus time curve from time zero to the last measurable time point (time t). Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Day 1; Weeks 7 and 24

Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Ofatumumab	Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab	Day 1, n=8	1345.1 hr*mcg/mL
Ofatumumab	Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab	Week 7, n=8	587711.3 hr*mcg/mL
Ofatumumab	Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab	Week 24, n=7	283751.4 hr*mcg/mL

Secondary

Clearance (CL) of Ofatumumab From Plasma

CL of ofatumumab from plasma of participants was evaluated. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Day 1; Weeks 7 and 24

Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Ofatumumab	Clearance (CL) of Ofatumumab From Plasma	Day 1, n=8	199.157 mL/hr
Ofatumumab	Clearance (CL) of Ofatumumab From Plasma	Week 7, n=8	9.991 mL/hr
Ofatumumab	Clearance (CL) of Ofatumumab From Plasma	Week 24, n=7	9.230 mL/hr

Secondary

Duration of Response as Assessed by a SERC

Duration of response is defined as the time from the first documented evidence of PR or better until the first documented sign of PD or death due to any reason in participants with PR or better.

Time frame: Up to Week 48

Population: All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.

Arm	Measure	Value (MEDIAN)
Ofatumumab	Duration of Response as Assessed by a SERC	NA Weeks

Secondary

Half-life (t1/2) of Ofatumumab

t1/2 of ofatumumab is the time required for the plasma concentration of ofatumumab to decrease by half. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Day 1; Weeks 7 and 24

Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Ofatumumab	Half-life (t1/2) of Ofatumumab	Week 7, n=8	331.275 hr
Ofatumumab	Half-life (t1/2) of Ofatumumab	Day 1, n=8	9.585 hr
Ofatumumab	Half-life (t1/2) of Ofatumumab	Week 24, n=7	300.354 hr

Secondary

Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab

Blood sampling on Day 1 and at Weeks 7 and 24 for pharmacokinetic (PK) evaluation was performed at the following time points: 0.5 hour (hr) before infusion; end of infusion; and 10 minutes (min), 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Day 1; Weeks 7 and 24

Population: PK Parameter Population: all participants who received at least one dose of investigational drug, and in whom PK data were available and allowed parameter estimations. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Ofatumumab	Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab	Day 1, n=8	69.33 Micrograms per milliliter (mcg/mL)
Ofatumumab	Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab	Week 7, n=8	1670.36 Micrograms per milliliter (mcg/mL)
Ofatumumab	Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab	Week 24, n=7	864.93 Micrograms per milliliter (mcg/mL)

Secondary

Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48

Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.

Time frame: Baseline and Weeks 8, 24, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	IgA, Week 8, n=9	0.014 g/L	Standard Deviation 0.1337
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	IgA, Week 24, n=9	-0.023 g/L	Standard Deviation 0.0865
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	IgA, Week 48, n=7	0.086 g/L	Standard Deviation 0.2889
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	IgG, Week 8, n=9	0.647 g/L	Standard Deviation 0.9004
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	IgG, Week 24, n=10	-0.150 g/L	Standard Deviation 0.8641
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	IgG, Week 48, n=7	-0.587 g/L	Standard Deviation 0.968
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	IgM, Week 8, n=7	-0.063 g/L	Standard Deviation 0.1482
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	IgM, Week 24, n=8	-0.058 g/L	Standard Deviation 0.1831
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48	IgM, Week 48, n=5	-0.108 g/L	Standard Deviation 0.1809

Secondary

Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator

Blood samples of the participants were collected for the assessment of hemoglobin.

Time frame: Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 8, n=10	119.8 Grams per liter (g/L)	Standard Deviation 20.35
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 12, n=10	122.6 Grams per liter (g/L)	Standard Deviation 20.55
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 16, n=10	125.6 Grams per liter (g/L)	Standard Deviation 21.08
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Day 1, n=10	115.7 Grams per liter (g/L)	Standard Deviation 15.44
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 1, n=10	116.0 Grams per liter (g/L)	Standard Deviation 15.46
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 2, n=10	117.4 Grams per liter (g/L)	Standard Deviation 16.37
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 3, n=10	117.0 Grams per liter (g/L)	Standard Deviation 18.68
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 4, n=10	116.1 Grams per liter (g/L)	Standard Deviation 18.53
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 5, n=10	116.4 Grams per liter (g/L)	Standard Deviation 17.83
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 6, n=10	118.1 Grams per liter (g/L)	Standard Deviation 16.25
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 7, n=10	118.4 Grams per liter (g/L)	Standard Deviation 20.06
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 20, n=10	127.8 Grams per liter (g/L)	Standard Deviation 21.81
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 24, n=10	127.8 Grams per liter (g/L)	Standard Deviation 22.31
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 28, n=9	126.2 Grams per liter (g/L)	Standard Deviation 21.49
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 36, n=9	128.1 Grams per liter (g/L)	Standard Deviation 20.91
Ofatumumab	Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator	Week 48, n=7	137.1 Grams per liter (g/L)	Standard Deviation 11.01

Secondary

Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC

SERC assessed lymphocytes in the bone marrow (BM) based on the data with BM smears provided by trial sites.

Time frame: Weeks 8, 16, 24, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC	Week 48, n=5	23.26 percentage of lymphocytes in BM	Standard Deviation 9.651
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC	Week 8, n=8	57.90 percentage of lymphocytes in BM	Standard Deviation 23.492
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC	Week 16, n=5	38.04 percentage of lymphocytes in BM	Standard Deviation 14.647
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC	Week 24, n=7	36.96 percentage of lymphocytes in BM	Standard Deviation 14.961
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC	Week 36, n=6	29.13 percentage of lymphocytes in BM	Standard Deviation 17.379

Secondary

Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator

Bone marrow (BM) aspiration was performed, and the bone marrow smears were prepared for the assessment of lymphocytes in the BM.

Time frame: Weeks 8, 16, 24, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator	Week 36, n=6	30.00 Percentage of lymphocytes in the BM	Standard Deviation 17.03
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator	Week 8, n=8	57.90 Percentage of lymphocytes in the BM	Standard Deviation 23.492
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator	Week 16, n=5	38.04 Percentage of lymphocytes in the BM	Standard Deviation 14.647
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator	Week 24, n=7	36.96 Percentage of lymphocytes in the BM	Standard Deviation 14.961
Ofatumumab	Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator	Week 48, n=5	23.26 Percentage of lymphocytes in the BM	Standard Deviation 9.651

Secondary

Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC

SERC assessed lymphocytes based on the data provided by trial sites.

Time frame: Weeks 8, 16, 24, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC	Week 8, n=8	2.0120 GI/L	Standard Deviation 1.03095
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC	Week 16, n=6	1.7975 GI/L	Standard Deviation 1.05163
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC	Week 24, n=7	1.8784 GI/L	Standard Deviation 1.56286
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC	Week 36, n=6	2.1213 GI/L	Standard Deviation 2.6556
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC	Week 48, n=5	1.6284 GI/L	Standard Deviation 0.70741

Secondary

Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator

Blood samples of the participants were collected for the assessment of lymphocytes.

Time frame: Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 7, n=10	2.4792 Giga (10^9) per liter (GI/L)	Standard Deviation 1.20853
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 8, n=10	2.1515 Giga (10^9) per liter (GI/L)	Standard Deviation 0.94237
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 12, n=10	1.8058 Giga (10^9) per liter (GI/L)	Standard Deviation 0.95653
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Day 1, n=10	42.6038 Giga (10^9) per liter (GI/L)	Standard Deviation 41.66244
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 1, n=10	29.6861 Giga (10^9) per liter (GI/L)	Standard Deviation 33.19072
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 2, n=10	8.2290 Giga (10^9) per liter (GI/L)	Standard Deviation 6.76264
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 3, n=10	6.9065 Giga (10^9) per liter (GI/L)	Standard Deviation 6.81649
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 4, n=10	4.0446 Giga (10^9) per liter (GI/L)	Standard Deviation 2.70652
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 5, n=10	2.9535 Giga (10^9) per liter (GI/L)	Standard Deviation 1.47227
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 6, n=10	2.8063 Giga (10^9) per liter (GI/L)	Standard Deviation 1.43681
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 16, n=10	1.9575 Giga (10^9) per liter (GI/L)	Standard Deviation 1.0988
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 20, n=10	1.8388 Giga (10^9) per liter (GI/L)	Standard Deviation 1.22494
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 24, n=10	1.8500 Giga (10^9) per liter (GI/L)	Standard Deviation 1.33979
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 28, n=9	1.6405 Giga (10^9) per liter (GI/L)	Standard Deviation 1.05653
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 36, n=9	3.5754 Giga (10^9) per liter (GI/L)	Standard Deviation 5.38456
Ofatumumab	Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator	Week 48, n=7	1.5099 Giga (10^9) per liter (GI/L)	Standard Deviation 0.72285

Secondary

Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator

Blood samples of the participants were collected for the assessment of platelets.

Time frame: Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 36, n=9	143.0 GI/L	Standard Deviation 43.19
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 48, n=7	130.7 GI/L	Standard Deviation 53.7
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Day 1, n=10	106.5 GI/L	Standard Deviation 31.69
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 1, n=10	104.0 GI/L	Standard Deviation 45.45
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 2, n=10	100.1 GI/L	Standard Deviation 37.21
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 3, n=10	118.3 GI/L	Standard Deviation 40.9
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 4, n=10	114.9 GI/L	Standard Deviation 46.26
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 5, n=10	111.5 GI/L	Standard Deviation 47.11
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 6, n=10	115.7 GI/L	Standard Deviation 49.86
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 7, n=10	121.4 GI/L	Standard Deviation 54.65
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 8, n=10	127.7 GI/L	Standard Deviation 64.44
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 12, n=10	120.1 GI/L	Standard Deviation 46.29
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 16, n=10	124.3 GI/L	Standard Deviation 46
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 20, n=10	134.0 GI/L	Standard Deviation 41.66
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 24, n=10	136.6 GI/L	Standard Deviation 44.14
Ofatumumab	Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator	Week 28, n=9	128.9 GI/L	Standard Deviation 41.64

Secondary

Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator

Blood samples of the participants were collected for the assessment of total neutrophils.

Time frame: Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Day 1, n=10	4.3103 GI/L	Standard Deviation 1.9188
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 1, n=10	3.9316 GI/L	Standard Deviation 2.37732
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 2, n=10	3.2158 GI/L	Standard Deviation 1.62185
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 3, n=10	2.7873 GI/L	Standard Deviation 1.16531
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 4, n=10	2.4570 GI/L	Standard Deviation 1.22611
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 5, n=10	2.3908 GI/L	Standard Deviation 0.9925
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 6, n=10	2.1747 GI/L	Standard Deviation 1.00743
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 7, n=10	2.1612 GI/L	Standard Deviation 1.22393
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 8, n=10	2.2136 GI/L	Standard Deviation 1.22993
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 12, n=10	1.9814 GI/L	Standard Deviation 0.90783
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 16, n=10	1.9915 GI/L	Standard Deviation 1.00746
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 20, n=10	2.2165 GI/L	Standard Deviation 1.29881
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 24, n=10	2.3093 GI/L	Standard Deviation 1.1884
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 28, n=9	2.2069 GI/L	Standard Deviation 1.57995
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 36, n=9	2.3482 GI/L	Standard Deviation 1.04228
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator	Week 48, n=7	3.0431 GI/L	Standard Deviation 1.6758

Secondary

Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC

SERC assessed total neutrophils based on the data provided by trial sites.

Time frame: Weeks 8, 16, 24, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC	Week 8, n=8	2.3159 GI/L	Standard Deviation 1.35507
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC	Week 16, n=6	2.5803 GI/L	Standard Deviation 1.04075
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC	Week 24, n=7	2.8706 GI/L	Standard Deviation 1.39803
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC	Week 36, n=6	2.1957 GI/L	Standard Deviation 0.89898
Ofatumumab	Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC	Week 48, n=5	2.6242 GI/L	Standard Deviation 1.05912

Secondary

Mean Residence Time (MRTinf) of Ofatumumab

MRTinf is the average amount of time that ofatumumab spends in the body. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Day 1; Weeks 7 and 24

Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Ofatumumab	Mean Residence Time (MRTinf) of Ofatumumab	Day 1, n=8	18.417 hr
Ofatumumab	Mean Residence Time (MRTinf) of Ofatumumab	Week 24, n=7	463.945 hr
Ofatumumab	Mean Residence Time (MRTinf) of Ofatumumab	Week 7, n=8	478.105 hr

Secondary

Minimum Plasma Concentration (Cmin) of Ofatumumab

Blood sampling at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Weeks 7 and 24

Population: PK Parameter Population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Ofatumumab	Minimum Plasma Concentration (Cmin) of Ofatumumab	Week 7	832.17 mcg/mL
Ofatumumab	Minimum Plasma Concentration (Cmin) of Ofatumumab	Week 24	122.08 mcg/mL

Secondary

Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48

HAHA are indicators of immunogenicity to ofatumumab.

Time frame: Screening; Weeks 24 and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48	Positive at Screening, n=10	0 participants
Ofatumumab	Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48	Negative at Screening, n=10	10 participants
Ofatumumab	Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48	Positive at Week 24, n=10	0 participants
Ofatumumab	Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48	Negative at Week 24, n=10	10 participants
Ofatumumab	Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48	Negative at Week 48, n=7	7 participants
Ofatumumab	Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48	Positive at Week 48, n=7	0 participants

Secondary

Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

ECOG PS is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. The grades for the scale range from 0 (fully active) to 4 (completely disabled), with increasing severity.

Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 1, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 1, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 2, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 2, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 3, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 3, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 4, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 5, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 5, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 6, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 6, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 7, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 7, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 8, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 8, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 12, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 12, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 16, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 16, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 20, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 20, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 24, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 24, deteriorated; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 28, improved; n=9	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 28, deteriorated; n=9	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 36, improved; n=9	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 36, deteriorated; n=9	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 48, improved; n=7	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 4, improved; n=10	0 participants
Ofatumumab	Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	Week 48, deteriorated; n=7	0 participants

Secondary

Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks

Extreme fatigue is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had extreme fatigue at BL, and still had extreme fatigue at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had extreme fatigue at BL, but did not have extreme fatigue at Week 1 are represented in the BL, yes; Week 1, no category.

Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 16, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 5, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 5, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 3, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 3, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 4, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 4, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 4, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 4, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 6, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 6, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 6, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 7, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 7, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 7, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 7, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 8, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 8, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 8, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 8, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 12, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 12, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 12, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 12, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 16, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 16, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 16, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 20, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 20, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 20, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 20, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 24, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 24, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 28, no; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 28, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 28, no; n=9	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 36, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 36, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 36, no; n=9	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 48, no; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 48, yes; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 5, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 5, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 1, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 6, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 24, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 24, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 28, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 36, no; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 48, yes; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 48, no; n=7	7 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 1, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 1, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 1, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 2, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 2, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 2, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, no; Week 2, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 3, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks	BL, yes; Week 3, no; n=10	0 participants

Secondary

Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks

Fever is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had fever at BL, and still had fever at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had fever at BL, but did not have fever at Week 1 are represented in the BL, yes; Week 1, no category.

Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 1, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 1, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 1, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 1, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 2, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 2, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 2, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 3, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 3, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 3, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 3, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 4, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 5, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 5, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 5, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 5, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 6, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 6, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 6, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 7, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 7, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 7, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 8, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 8, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 8, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 12, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 12, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 12, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 16, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 24, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 16, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 20, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 24, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 24, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 28, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 28, no; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 28, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 28, no; n=9	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 36, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 36, no; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 36, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 36, no; n=9	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 48, no; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 48, yes; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 2, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 4, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 4, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 4, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 6, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 7, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 8, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 12, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 16, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 16, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 20, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 20, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 20, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 24, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, yes; Week 48, yes; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks	BL, no; Week 48, no; n=7	7 participants

Secondary

Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks

Night sweats are one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had night sweats at BL, and still had night sweats at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had night sweats at BL, but did not have night sweats at Week 1 are represented in the BL, yes; Week 1, no category.

Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 4, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 1, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 1, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 1, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 1, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 2, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 5, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 6, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 6, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 6, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 6, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 7, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 7, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 7, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 8, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 8, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 8, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 8, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 2, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 20, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 20, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 20, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 24, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 24, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 24, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 24, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 28, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 28, no; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 2, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 28, yes; n=9	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 28, no; n=9	8 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 36, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 36, yes; n=9	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 36, no; n=9	8 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 48, yes; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 48, no; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 48, yes; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 48, no; n=7	7 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 2, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 3, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 3, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 5, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 5, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 5, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 7, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 12, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 12, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 12, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 12, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 16, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 16, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 16, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 16, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 20, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 36, no; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 3, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 3, no; n=10	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 4, yes; n=10	1 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, yes; Week 4, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks	BL, no; Week 4, yes; n=10	0 participants

Secondary

Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks

Weight loss is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had weight loss at BL, and still had weight loss at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had weight loss at BL, but did not have weight loss at Week 1 are represented in the BL, yes; Week 1, no category.

Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 5, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 5, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 5, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 6, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 6, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 6, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 6, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 7, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 7, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 7, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 7, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 8, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 8, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 8, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 8, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 12, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 12, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 12, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 12, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 16, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 16, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 16, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 16, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 20, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 20, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 20, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 2, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 2, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 3, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 3, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 3, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 20, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 3, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 4, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 4, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 4, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 4, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 5, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 1, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 24, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 24, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 24, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 36, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 36, no; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 36, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 36, no; n=9	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 48, yes; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 1, no; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 48, no; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 48, no; n=7	7 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 1, no; n=10	10 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 2, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 1, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 24, yes; n=10	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 28, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 28, no; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 28, yes; n=9	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 28, no; n=9	9 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, no; Week 48, yes; n=7	0 participants
Ofatumumab	Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks	BL, yes; Week 2, no; n=10	0 participants

Secondary

Number of Peripheral Blood CD19+ CD23+ Cells

CD19+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.

Time frame: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Day 1, n=10	23.8046 GI/L	Standard Deviation 28.66936
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 1, n=9	17.4769 GI/L	Standard Deviation 22.30923
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 2, n=10	4.6972 GI/L	Standard Deviation 6.14672
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 4, n=10	1.8230 GI/L	Standard Deviation 2.49206
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 6, n=10	0.4858 GI/L	Standard Deviation 0.55687
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 8, n=9	0.2252 GI/L	Standard Deviation 0.25765
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 12, n=10	0.2122 GI/L	Standard Deviation 0.26787
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 16, n=10	0.1961 GI/L	Standard Deviation 0.34108
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 20, n=10	0.1464 GI/L	Standard Deviation 0.33132
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 24, n=10	0.1330 GI/L	Standard Deviation 0.23961
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 28, n=9	0.1123 GI/L	Standard Deviation 0.2613
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 36, n=8	0.2687 GI/L	Standard Deviation 0.71524
Ofatumumab	Number of Peripheral Blood CD19+ CD23+ Cells	Week 48, n=7	0.0886 GI/L	Standard Deviation 0.11398

Secondary

Number of Peripheral Blood CD19+ CD5+ Cells

CD19+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.

Time frame: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Day 1, n=10	36.0022 GI/L	Standard Deviation 36.6491
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 1, n=9	27.9129 GI/L	Standard Deviation 32.61649
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 2, n=10	5.4212 GI/L	Standard Deviation 6.55286
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 4, n=10	2.2158 GI/L	Standard Deviation 2.62609
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 6, n=10	0.5799 GI/L	Standard Deviation 0.63484
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 8, n=9	0.2338 GI/L	Standard Deviation 0.27058
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 12, n=10	0.2420 GI/L	Standard Deviation 0.32493
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 16, n=10	0.2425 GI/L	Standard Deviation 0.38048
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 20, n=10	0.1943 GI/L	Standard Deviation 0.38386
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 24, n=10	0.1719 GI/L	Standard Deviation 0.29401
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 28, n=9	0.1449 GI/L	Standard Deviation 0.25617
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 36, n=8	0.2858 GI/L	Standard Deviation 0.73543
Ofatumumab	Number of Peripheral Blood CD19+ CD5+ Cells	Week 48, n=7	0.1200 GI/L	Standard Deviation 0.14511

Secondary

Number of Peripheral Blood CD20+ CD23+ Cells

CD20+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.

Time frame: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 4, n=10	0.0685 GI/L	Standard Deviation 0.14483
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Day 1, n=10	19.9791 GI/L	Standard Deviation 27.06441
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 1, n=9	8.9466 GI/L	Standard Deviation 21.59662
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 2, n=10	0.0319 GI/L	Standard Deviation 0.0401
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 6, n=10	0.0099 GI/L	Standard Deviation 0.01869
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 8, n=9	0.0047 GI/L	Standard Deviation 0.01131
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 12, n=10	0.0080 GI/L	Standard Deviation 0.0227
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 16, n=10	0.0111 GI/L	Standard Deviation 0.03162
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 20, n=10	0.0048 GI/L	Standard Deviation 0.01277
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 24, n=10	0.0057 GI/L	Standard Deviation 0.01553
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 28, n=9	0.0002 GI/L	Standard Deviation 0.0004
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 36, n=8	0.2147 GI/L	Standard Deviation 0.60466
Ofatumumab	Number of Peripheral Blood CD20+ CD23+ Cells	Week 48, n=7	0.0773 GI/L	Standard Deviation 0.09355

Secondary

Number of Peripheral Blood CD20+ CD5+ Cells

CD20+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.

Time frame: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Day 1, n=10	32.9606 GI/L	Standard Deviation 39.50102
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 1, n=9	19.3999 GI/L	Standard Deviation 35.56146
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 2, n=10	0.0134 GI/L	Standard Deviation 0.01696
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 4, n=10	0.0493 GI/L	Standard Deviation 0.13576
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 6, n=10	0.0024 GI/L	Standard Deviation 0.00185
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 8, n=9	0.0029 GI/L	Standard Deviation 0.00136
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 12, n=10	0.0020 GI/L	Standard Deviation 0.0016
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 16, n=10	0.0062 GI/L	Standard Deviation 0.00907
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 20, n=10	0.0026 GI/L	Standard Deviation 0.00147
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 24, n=10	0.0036 GI/L	Standard Deviation 0.00258
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 28, n=9	0.0022 GI/L	Standard Deviation 0.00214
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 36, n=8	0.2597 GI/L	Standard Deviation 0.72781
Ofatumumab	Number of Peripheral Blood CD20+ CD5+ Cells	Week 48, n=7	0.0968 GI/L	Standard Deviation 0.11682

Secondary

Number of Peripheral Blood CD23+ CD5+ Cells

CD23+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.

Time frame: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Day 1, n=10	22.7190 GI/L	Standard Deviation 25.17338
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 1, n=9	17.2018 GI/L	Standard Deviation 21.23454
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 2, n=10	4.5264 GI/L	Standard Deviation 6.03353
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 4, n=10	1.8255 GI/L	Standard Deviation 2.49671
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 6, n=10	0.4714 GI/L	Standard Deviation 0.50306
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 8, n=9	0.2095 GI/L	Standard Deviation 0.23907
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 12, n=10	0.2114 GI/L	Standard Deviation 0.27306
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 16, n=10	0.1866 GI/L	Standard Deviation 0.34514
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 20, n=10	0.1478 GI/L	Standard Deviation 0.32088
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 24, n=10	0.1327 GI/L	Standard Deviation 0.23698
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 28, n=9	0.1035 GI/L	Standard Deviation 0.23789
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 36, n=8	0.2570 GI/L	Standard Deviation 0.68983
Ofatumumab	Number of Peripheral Blood CD23+ CD5+ Cells	Week 48, n=7	0.1062 GI/L	Standard Deviation 0.13388

Secondary

Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells

CD19+ CD20+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.

Time frame: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 4, n=10	0.0565 GI/L	Standard Deviation 0.16699
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 6, n=10	0.0022 GI/L	Standard Deviation 0.00258
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Day 1, n=10	33.1140 GI/L	Standard Deviation 39.40966
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 1, n=9	19.6438 GI/L	Standard Deviation 35.81756
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 2, n=10	0.0060 GI/L	Standard Deviation 0.01151
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 8, n=9	0.0006 GI/L	Standard Deviation 0.00136
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 12, n=10	0.0006 GI/L	Standard Deviation 0.00116
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 16, n=10	0.0003 GI/L	Standard Deviation 0.00058
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 20, n=10	0.0005 GI/L	Standard Deviation 0.00087
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 24, n=10	0.0002 GI/L	Standard Deviation 0.00037
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 28, n=9	0.0003 GI/L	Standard Deviation 0.00093
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 36, n=8	0.2525 GI/L	Standard Deviation 0.71266
Ofatumumab	Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells	Week 48, n=7	0.0914 GI/L	Standard Deviation 0.10259

Secondary

Overall Survival

Overall survival is defined as the time from the first infusion of investigational drug to death due to any cause.

Time frame: Up to Week 48

Population: All Subjects Population

Arm	Measure	Value (MEDIAN)
Ofatumumab	Overall Survival	NA Weeks

Secondary

Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC

SERC assessed bone marrow infiltration with the bone marrow smears of participants provided by trial sites.

Time frame: Weeks 8, 16, 24, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC	Week 8, n=8	57.90 Percentage of bone marrow infiltration	Standard Deviation 23.492
Ofatumumab	Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC	Week 16, n=5	38.04 Percentage of bone marrow infiltration	Standard Deviation 14.647
Ofatumumab	Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC	Week 24, n=7	36.96 Percentage of bone marrow infiltration	Standard Deviation 14.961
Ofatumumab	Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC	Week 36, n=6	29.13 Percentage of bone marrow infiltration	Standard Deviation 17.379
Ofatumumab	Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC	Week 48, n=5	23.26 Percentage of bone marrow infiltration	Standard Deviation 9.651

Secondary

Progression-free Survival (PFS) as Assessed by a SERC

PFS is defined as the time from the start of treatment to the first documented sign of progressive disease (PD) or death due to any cause (whichever occurs earlier).

Time frame: Up to Week 48

Population: All Subjects Population: only those participants who progressed or died during the study were evaluated.

Arm	Measure	Value (MEDIAN)
Ofatumumab	Progression-free Survival (PFS) as Assessed by a SERC	NA Weeks

Secondary

Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda

Peripheral blood Ig kappa and Ig lambda were measured using flow cytometry. Abnormality of a ratio of Ig kappa and Ig lambda indicates clonality of lymphocytes. A normal range of this parameter is between 1.0 and 3.2.

Time frame: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 16, n=10	2.150 Ratio of Ig kappa/Ig lambda	Standard Deviation 3.8972
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 20, n=10	2.017 Ratio of Ig kappa/Ig lambda	Standard Deviation 3.8733
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 24, n=10	1.608 Ratio of Ig kappa/Ig lambda	Standard Deviation 2.6223
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 28, n=9	1.647 Ratio of Ig kappa/Ig lambda	Standard Deviation 2.3965
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 36, n=8	1.693 Ratio of Ig kappa/Ig lambda	Standard Deviation 1.8636
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 48, n=7	3.368 Ratio of Ig kappa/Ig lambda	Standard Deviation 5.2575
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 12, n=10	3.799 Ratio of Ig kappa/Ig lambda	Standard Deviation 8.8774
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Day 1, n=10	34.710 Ratio of Ig kappa/Ig lambda	Standard Deviation 38.2375
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 1, n=9	36.604 Ratio of Ig kappa/Ig lambda	Standard Deviation 36.9383
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 2, n=10	15.928 Ratio of Ig kappa/Ig lambda	Standard Deviation 26.5203
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 4, n=10	9.451 Ratio of Ig kappa/Ig lambda	Standard Deviation 25.1555
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 6, n=10	7.263 Ratio of Ig kappa/Ig lambda	Standard Deviation 20.3014
Ofatumumab	Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda	Week 8, n=9	6.427 Ratio of Ig kappa/Ig lambda	Standard Deviation 16.7389

Secondary

Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC

Time to next CLL therapy is defined as the time from the first infusion of investigational drug to the first administration of the next CLL treatment. CLL therapy includes anti-cancer chemotherapy, anti-cancer radiotherapy, radio-immunotherapy, and antibody therapy.

Time frame: Up to Week 48

Population: All Subjects Population: only those participants who received CLL therapy were evaluated.

Arm	Measure	Value (MEDIAN)
Ofatumumab	Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC	NA Weeks

Secondary

Time to Reach Cmax (Tmax) Following Ofatumumab Administration

Time frame: Day 1; Weeks 7 and 24

Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEDIAN)
Ofatumumab	Time to Reach Cmax (Tmax) Following Ofatumumab Administration	Day 1, n=8	7.208 hr
Ofatumumab	Time to Reach Cmax (Tmax) Following Ofatumumab Administration	Week 24, n=7	5.250 hr
Ofatumumab	Time to Reach Cmax (Tmax) Following Ofatumumab Administration	Week 7, n=8	5.225 hr

Secondary

Time to Response as Assessed by a SERC

Time to response is defined as the time from the first infusion of investigational drug to the first response (PR or better).

Time frame: Up to Week 48

Population: All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.

Arm	Measure	Value (MEDIAN)
Ofatumumab	Time to Response as Assessed by a SERC	8.1 Weeks

Secondary

Volume of Distribution at Steady State (Vss) for Ofatumumab

Vss for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body in equilibrium conditions to steady-state plasma concentrations. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Day 1; Weeks 7 and 24

Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Ofatumumab	Volume of Distribution at Steady State (Vss) for Ofatumumab	Week 7, n=8	1333.8 mL
Ofatumumab	Volume of Distribution at Steady State (Vss) for Ofatumumab	Week 24, n=7	3069.2 mL
Ofatumumab	Volume of Distribution at Steady State (Vss) for Ofatumumab	Day 1, n=8	3667.9 mL

Secondary

Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab

Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.

Time frame: Day 1; Weeks 7 and 24

Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Ofatumumab	Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab	Day 1, n=8	2754.1 mL
Ofatumumab	Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab	Week 7, n=8	4774.9 mL
Ofatumumab	Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab	Week 24, n=7	3999.7 mL

Other Pre-specified

Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50

The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it's is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation.

Time frame: Weeks 36 and 48

Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50	Week 36, n=8	45.14 Kilo units per liter (KU/L)	Standard Deviation 13.643
Ofatumumab	Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50	Week 48, n=7	53.70 Kilo units per liter (KU/L)	Standard Deviation 11.818

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With a Dose-limiting Toxicity (DLT)

Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator

Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7

Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab

Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab

Clearance (CL) of Ofatumumab From Plasma

Duration of Response as Assessed by a SERC

Half-life (t1/2) of Ofatumumab

Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab

Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48

Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator

Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC

Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator

Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC

Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator

Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator

Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator

Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC

Mean Residence Time (MRTinf) of Ofatumumab

Minimum Plasma Concentration (Cmin) of Ofatumumab

Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48

Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks

Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks

Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks

Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks

Number of Peripheral Blood CD19+ CD23+ Cells

Number of Peripheral Blood CD19+ CD5+ Cells

Number of Peripheral Blood CD20+ CD23+ Cells

Number of Peripheral Blood CD20+ CD5+ Cells

Number of Peripheral Blood CD23+ CD5+ Cells

Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells

Overall Survival

Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC

Progression-free Survival (PFS) as Assessed by a SERC

Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda

Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC

Time to Reach Cmax (Tmax) Following Ofatumumab Administration

Time to Response as Assessed by a SERC

Volume of Distribution at Steady State (Vss) for Ofatumumab

Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab

Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50