Chronic Lymphocytic Leukemia (CLL)
Conditions
Keywords
Chronic lymphocytic leukemia; leukemia; B-Cell malignancy; anti-CD19; monoclonal antibody; CLL; Refractory; Relapse; Non-Hodgkin's Lymphoma
Brief summary
The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.
Interventions
DRUGRituximab
Rituximab was administered by IV infusion as a dose of 375 mg/m\^2 on Day 2 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycles
DRUGBendamustine
Bendamustine was administered by IV infusion as a dose of 70 mg/m\^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle.
DRUGMEDI-551
MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed B-cell Chronic Lymphocytic Leukemia (CLL) according to the National Cancer Institute criteria; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Adequate hematological function
Exclusion criteria
* Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal therapy for treatment of lymphoma within 28 days prior to treatment; * Exposure to bendamustine within the 180 days before study enrollment * Prior autologous or allogeneic stem cell transplantation (SCT); * Clinically significant abnormality on electrocardiogram (ECG) as determined by the treating physician or medical monitor; * History of other invasive malignancy within 5 years except for localized/in situ carcinomas; * Evidence of active infection, Confirmed current central nervous system involvement by leukemia or lymphoma;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months) | ORR, defined as the proportion of participants with complete response (CR) or partial response (PR) out of total number of participants. Responses were assessed by using National Cancer Institute - Working Group guidelines on CLL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | From time of consent to 90 days post last dose | An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed. |
| Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | From time of consent to 90 days post last dose | AEs observed in participants with clinically significant ECG abnormalities were assessed. |
| Complete Response Rate | From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months) | Complete response was as per IWG was the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. |
| Minimal Residual Disease Negative Complete Response (CR) Rate | From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months) | The MRD-negative CR rate was defined as the percentage of participants who achieved CR and became MRD-negative as determined by flow cytometry. CR as per International Working Group (IWG) was complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. |
| Time to Response | From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months) | Time to response was evaluated using the Kaplan-Meier method. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | From time of consent to 90 days post last dose | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug (MEDI-551). A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 90 that were absent before treatment or that worsened relative to pre-treatment state. An AESIs was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through Day 90 after the last dose of study drug.Hepatic function abnormality and infusion reactions resulting in discontinuation were considered as AESIs. |
| Progression Free Survival (PFS) | From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months) | PFS was measured from the start of treatment with study drug until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation. |
| Overall Survival (OS) | From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months) | OS was determined as the time from the start of treatment with study drug until death due to any cause. For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive. Kaplan-Meier method was used for evaluation. |
| Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA) | From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months) | A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study. |
| Terminal Half Life (t1/2) of MEDI-551 | Pre-infusion and 1 hour post infusion on Days 2 and 8, Days 15 and 22 of cycle 1 | Terminal phase elimination half-life (T1/2) was the time required for half of the drug to be eliminated from the serum. |
| Time to Disease Progression (TTP) | From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months) | TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. |
Countries
Belgium, Canada, France, Germany, Israel, Italy, Poland, United States
Participant flow
Pre-assignment details
A total of 182 participants were screened and 159 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Rituximab + Bendamustine Rituximab was administered by IV infusion as 375 mg/m\^2 on Day 2 of Cycle 1 and then 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle. | 62 |
| MEDI-551 2 mg/kg + Bendamustine MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle. | 36 |
| MEDI-551 4 mg/kg + Bendamustine MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle. | 61 |
| TOTAL Total of all reporting groups | 159 |
| Total | 318 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 14 | 13 | 17 |
| Overall Study | Disease Progression | 2 | 2 | 0 |
| Overall Study | Investigator Discretion | 3 | 2 | 2 |
| Overall Study | Other-Unspecified | 6 | 4 | 2 |
| Overall Study | Randomized-Not Treated | 2 | 3 | 4 |
| Overall Study | Withdrawal of Consent | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Rituximab + Bendamustine | MEDI-551 2 mg/kg + Bendamustine | MEDI-551 4 mg/kg + Bendamustine | TOTAL |
|---|---|---|---|---|
| Age, Continuous | 63.4 YEARS STANDARD_DEVIATION 8.8 | 65.1 YEARS STANDARD_DEVIATION 8.7 | 66.3 YEARS STANDARD_DEVIATION 8.9 | 65.1 YEARS STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 18 Participants | 48 Participants |
| Sex: Female, Male Male | 46 Participants | 22 Participants | 43 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 58 / 60 | 31 / 33 | 54 / 57 |
| serious Total, serious adverse events | 19 / 60 | 16 / 33 | 19 / 57 |
Outcome results
Primary
Objective Response Rate
ORR, defined as the proportion of participants with complete response (CR) or partial response (PR) out of total number of participants. Responses were assessed by using National Cancer Institute - Working Group guidelines on CLL.
Time frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
Population: Intent-to-treat (ITT) population includes all participants who were randomized into the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab + Bendamustine | Objective Response Rate | 59.7 Percentage of Participants |
| MEDI-551 2 mg/kg + Bendamustine | Objective Response Rate | 52.8 Percentage of Participants |
| MEDI-551 4 mg/kg + Bendamustine | Objective Response Rate | 63.9 Percentage of Participants |
p-value: 0.4475Cochran-Mantel-Haenszel
Secondary
Complete Response Rate
Complete response was as per IWG was the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
Time frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
Population: Intent-to-treat (ITT) population includes all participants who were randomized into the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab + Bendamustine | Complete Response Rate | 6.5 Percentage of Participants |
| MEDI-551 2 mg/kg + Bendamustine | Complete Response Rate | 5.6 Percentage of Participants |
| MEDI-551 4 mg/kg + Bendamustine | Complete Response Rate | 11.5 Percentage of Participants |
p-value: 0.3206Cochran-Mantel-Haenszel
Secondary
Minimal Residual Disease Negative Complete Response (CR) Rate
The MRD-negative CR rate was defined as the percentage of participants who achieved CR and became MRD-negative as determined by flow cytometry. CR as per International Working Group (IWG) was complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
Time frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
Population: Intent-to-treat (ITT) population includes all participants who were randomized into the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab + Bendamustine | Minimal Residual Disease Negative Complete Response (CR) Rate | 1.6 Percentage of Participants |
| MEDI-551 2 mg/kg + Bendamustine | Minimal Residual Disease Negative Complete Response (CR) Rate | 5.6 Percentage of Participants |
| MEDI-551 4 mg/kg + Bendamustine | Minimal Residual Disease Negative Complete Response (CR) Rate | 4.9 Percentage of Participants |
p-value: 0.313Cochran-Mantel-Haenszel
Secondary
Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA)
A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
Time frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
Population: The safety population includes all participants who received any investigational product. Participants whom ADA samples were available were analyzed for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab + Bendamustine | Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA) | 4 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA) | 8 Participants |
Secondary
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Time frame: From time of consent to 90 days post last dose
Population: The safety population includes all participants who received any investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperbilirubinaemia | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Anaemia | 18 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyponatraemia | 2 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Platelet Count Decreased | 2 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hepatic enzyme Increased | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Alanine Aminotransferase Increased | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperkalaemia | 2 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Gamma-Glutamyltransferase Increased | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Aspartate Aminotransferase Increased | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Urea Increased | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Alkaline Phosphatase Increased | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Neutrophil Count Decreased | 9 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Lactate Dehydrogenase Increased | 4 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Bilirubin Increased | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperlipidaemia | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Immunoglobulin G Decreased | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Cholesterol Decreased | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | White Blood Cells in Urine | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Creatinine Increased | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Creatinine Decreased | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Lymphocyte Count Decreased | 3 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypermagnesaemia | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Proteinuria | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Immunoglobulin g Decreased | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperphosphataemia | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Haemoglobin Decreased | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Fibrinogen Increased | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypertriglyceridaemia | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Haematuria | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Activated Partial Thromboplastin Time Prolonged | 2 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperuricaemia | 3 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypercholesterolaemia | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Thromobocytopenia | 12 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypoalbuminaemia | 2 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypercalcaemia | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Neutropenia | 28 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypocalcaemia | 3 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Prothrombin Time Shortened | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Lymphopenia | 4 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypokalaemia | 6 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperglycaemia | 4 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Eosinophilia | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypomagnesaemia | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperkalaemia | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperbilirubinaemia | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypercalcaemia | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypercholesterolaemia | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperglycaemia | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperlipidaemia | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypermagnesaemia | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperphosphataemia | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypertriglyceridaemia | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperuricaemia | 5 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypoalbuminaemia | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypocalcaemia | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypokalaemia | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypomagnesaemia | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyponatraemia | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Alanine Aminotransferase Increased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Aspartate Aminotransferase Increased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Alkaline Phosphatase Increased | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Bilirubin Increased | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Cholesterol Decreased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Creatinine Decreased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Creatinine Increased | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Immunoglobulin G Decreased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Lactate Dehydrogenase Increased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Urea Increased | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Gamma-Glutamyltransferase Increased | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hepatic enzyme Increased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Anaemia | 7 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Eosinophilia | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Lymphopenia | 3 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Neutropenia | 10 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Thromobocytopenia | 6 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Activated Partial Thromboplastin Time Prolonged | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Fibrinogen Increased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Immunoglobulin g Decreased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Haemoglobin Decreased | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Lymphocyte Count Decreased | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Neutrophil Count Decreased | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Platelet Count Decreased | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Prothrombin Time Shortened | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Haematuria | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Proteinuria | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | White Blood Cells in Urine | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperglycaemia | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Eosinophilia | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypocalcaemia | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | White Blood Cells in Urine | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Lymphopenia | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Neutropenia | 19 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypoalbuminaemia | 2 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Platelet Count Decreased | 3 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperuricaemia | 2 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypercholesterolaemia | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Thromobocytopenia | 10 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypertriglyceridaemia | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Proteinuria | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Activated Partial Thromboplastin Time Prolonged | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperphosphataemia | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Prothrombin Time Shortened | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Fibrinogen Increased | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypermagnesaemia | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypercalcaemia | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Immunoglobulin g Decreased | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Immunoglobulin G Decreased | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Creatinine Decreased | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Cholesterol Decreased | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Haemoglobin Decreased | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Creatinine Increased | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Bilirubin Increased | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperlipidaemia | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Alkaline Phosphatase Increased | 2 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Haematuria | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Lactate Dehydrogenase Increased | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Aspartate Aminotransferase Increased | 3 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Lymphocyte Count Decreased | 2 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Blood Urea Increased | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Alanine Aminotransferase Increased | 3 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperkalaemia | 2 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Gamma-Glutamyltransferase Increased | 2 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyponatraemia | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hyperbilirubinaemia | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hepatic enzyme Increased | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypomagnesaemia | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Neutrophil Count Decreased | 3 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Anaemia | 9 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs | Hypokalaemia | 4 Participants |
Secondary
Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs
AEs observed in participants with clinically significant ECG abnormalities were assessed.
Time frame: From time of consent to 90 days post last dose
Population: The safety population includes all participants who received any investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Sinus Tachycardia | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Atrial Fibrillation | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Atrioventricular Block | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Palpitations | 0 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Sinus Bradycardia | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Tachycardia | 2 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Pyrexia | 20 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Dyspnoea | 9 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Dyspnoea Exertional | 3 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Hypertension | 1 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Hypotension | 5 Participants |
| Rituximab + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Orthostatic Hypotension | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Orthostatic Hypotension | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Dyspnoea Exertional | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Atrial Fibrillation | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Pyrexia | 11 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Tachycardia | 1 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Atrioventricular Block | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Hypotension | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Dyspnoea | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Palpitations | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Sinus Tachycardia | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Hypertension | 0 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Sinus Bradycardia | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Hypotension | 6 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Sinus Tachycardia | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Hypertension | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Tachycardia | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Pyrexia | 14 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Dyspnoea | 4 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Sinus Bradycardia | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Atrial Fibrillation | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Dyspnoea Exertional | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Atrioventricular Block | 0 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Orthostatic Hypotension | 1 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs | Palpitations | 2 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug (MEDI-551). A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 90 that were absent before treatment or that worsened relative to pre-treatment state. An AESIs was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through Day 90 after the last dose of study drug.Hepatic function abnormality and infusion reactions resulting in discontinuation were considered as AESIs.
Time frame: From time of consent to 90 days post last dose
Population: The safety population includes all participants who received any investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab + Bendamustine | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | TESAEs | 19 Participants |
| Rituximab + Bendamustine | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | TEAEs | 58 Participants |
| Rituximab + Bendamustine | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | AESIs | 2 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | TESAEs | 16 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | TEAEs | 33 Participants |
| MEDI-551 2 mg/kg + Bendamustine | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | AESIs | 4 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | TEAEs | 57 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | AESIs | 6 Participants |
| MEDI-551 4 mg/kg + Bendamustine | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) | TESAEs | 19 Participants |
Secondary
Overall Survival (OS)
OS was determined as the time from the start of treatment with study drug until death due to any cause. For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive. Kaplan-Meier method was used for evaluation.
Time frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
Population: Intent-to-treat (ITT) population includes all participants who were randomized into the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab + Bendamustine | Overall Survival (OS) | NA Months |
| MEDI-551 2 mg/kg + Bendamustine | Overall Survival (OS) | NA Months |
| MEDI-551 4 mg/kg + Bendamustine | Overall Survival (OS) | NA Months |
Secondary
Progression Free Survival (PFS)
PFS was measured from the start of treatment with study drug until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.
Time frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
Population: Intent-to-treat (ITT) population includes all participants who were randomized into the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab + Bendamustine | Progression Free Survival (PFS) | 14.8 Months |
| MEDI-551 2 mg/kg + Bendamustine | Progression Free Survival (PFS) | 15.0 Months |
| MEDI-551 4 mg/kg + Bendamustine | Progression Free Survival (PFS) | 16.1 Months |
Secondary
Terminal Half Life (t1/2) of MEDI-551
Terminal phase elimination half-life (T1/2) was the time required for half of the drug to be eliminated from the serum.
Time frame: Pre-infusion and 1 hour post infusion on Days 2 and 8, Days 15 and 22 of cycle 1
Population: The safety population includes all participants who received any investigational product. Participants whom PK samples were available were analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab + Bendamustine | Terminal Half Life (t1/2) of MEDI-551 | 17.2 Day | Standard Deviation 9.56 |
| MEDI-551 2 mg/kg + Bendamustine | Terminal Half Life (t1/2) of MEDI-551 | 22.0 Day | Standard Deviation 14.4 |
Secondary
Time to Disease Progression (TTP)
TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death.
Time frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
Population: Intent-to-treat (ITT) population includes all participants who were randomized into the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab + Bendamustine | Time to Disease Progression (TTP) | 15.4 Months |
| MEDI-551 2 mg/kg + Bendamustine | Time to Disease Progression (TTP) | 15.0 Months |
| MEDI-551 4 mg/kg + Bendamustine | Time to Disease Progression (TTP) | 16.1 Months |
p-value: 0.9527Log Rank
Secondary
Time to Response
Time to response was evaluated using the Kaplan-Meier method.
Time frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
Population: Intent-to-treat (ITT) population includes all participants who were randomized into the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab + Bendamustine | Time to Response | 2.1 Months |
| MEDI-551 2 mg/kg + Bendamustine | Time to Response | 1.9 Months |
| MEDI-551 4 mg/kg + Bendamustine | Time to Response | 2.1 Months |