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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Given IV
M D Anderson Cancer Center
Houston, Texas, United States
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
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
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
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