Chronic Lymphocytic Leukemia
Conditions
Brief summary
This phase II trial studies how well ofatumumab works as front-line therapy in treating elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of cancer cells to grow and spread.
Detailed description
PRIMARY OBJECTIVES I. To evaluate the overall response rate of ofatumumab in the upfront setting in elderly, unfit patients with chronic lymphocytic leukemia (CLL). SECONDARY OBJECTIVES: I. To determine the overall survival with ofatumumab in upfront setting in elderly, unfit CLL patients. II. To evaluate the complete response rate and time to progression to therapy of ofatumumab in elderly, unfit patients with CLL. III. To determine the plasma levels of ofatumumab in elderly, unfit patients. IV. To evaluate predictive capability of micro ribonucleic acid (RNA) (miRNAs) detection in plasma samples. OUTLINE: Participants receive ofatumumab intravenously (IV) over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Interventions
BIOLOGICALOfatumumab
Given IV
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chronic lymphocytic leukemia requiring treatment at the time of signing informed consent. * Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 2-3 and a Cumulative Illness Rating Scale (CIRS) or Charlson co-morbidity score of 2 or higher. * Creatinine \< 2mg/dL. * Estimated glomerular filtration rate (eGFR) more than 30cc/minute. * Bilirubin \< 2mg/dL. * Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. * Patients with Gilbert's syndrome are eligible.
Exclusion criteria
* Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood). * Known positivity for human immunodeficiency virus (HIV). * Hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg). In addition, if negative for HGsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded. * Prior treatment for chronic lymphocytic leukemia. * Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not compromising bone marrow function does not apply. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received. * Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study. * Any known hypersensitivity to ofatumumab or its components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With a Response | Up to 3 years, 10 months | Response = (complete response \[CR\] + partial response \[PR\]) per 2008 National Cancer Institute (NCI)-Working Group (WG) criteria. Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. Partial Response (PR): At least 50 % reduction in disease signs/symptoms and normalization of peripheral blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Up to 3 years, 10 months | Time from date of treatment start until the date of first objective documentation of disease-relapse. |
| Participants With a Complete Response (CR) | Up to 3 years, 10 months | Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Ofatumumab) Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Ofatumumab: Given IV | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Treatment (Ofatumumab) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 34 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 73 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 29 / 34 |
| serious Total, serious adverse events | 9 / 34 |
Outcome results
Primary
Participants With a Response
Response = (complete response \[CR\] + partial response \[PR\]) per 2008 National Cancer Institute (NCI)-Working Group (WG) criteria. Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. Partial Response (PR): At least 50 % reduction in disease signs/symptoms and normalization of peripheral blood.
Time frame: Up to 3 years, 10 months
Population: Of the 34 participants registered, 32 were evaluable for response.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Ofatumumab) | Participants With a Response | 23 Participants |
Secondary
Participants With a Complete Response (CR)
Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow.
Time frame: Up to 3 years, 10 months
Population: Of the 34 participants registered, 32 were evaluable for response.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Ofatumumab) | Participants With a Complete Response (CR) | 6 Participants |
Secondary
Progression-free Survival (PFS)
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Time frame: Up to 3 years, 10 months
Population: Of the 34 participants registered, 32 were evaluable for response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Ofatumumab) | Progression-free Survival (PFS) | 21 Months |