This phase II trial studies how well blinatumomab works in treating patients with B-cell acute lymphoblastic leukemia whose disease is in remission (causes no symptoms or signs) but is still present in a small number of cells in the body (minimal residual disease). Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02458014.
PRIMARY OBJECTIVE:
I. To evaluate the clinical efficacy of blinatumomab in patients B-cell acute lymphoblastic leukemia in complete morphologic remission with positive minimal residual disease (MRD) in terms of relapse-free survival (RFS).
SECONDARY OBJECTIVE:
I. To evaluate other efficacy endpoints such as overall survival and MRD negativity rate by flow cytometry and/or polymerase chain reaction (PCR) overall and after the first cycle, as well as safety of blinatumomab in this setting.
OUTLINE:
Patients receive blinatumomab intravenously (IV) continuously on days 1-28 of each cycle. Treatment repeats every 6 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who do not proceed with stem cell transplantation may receive blinatumomab IV maintenance therapy with one cycle every 3 months for up to 4 cycles. Patients who remain in MRD remission for 3 months and then become MRD positive again can be retreated following the same treatment plan previously received. Patients also undergo bone marrow aspiration and/or biopsies within 21 days of therapy and on day 42 of the first cycle, then each cycle until MRD negativity is achieved and every 2-3 cycles thereafter. Patients also undergo a lumbar puncture within 21 days of therapy and an X-ray and/or positron emission tomography (PET)/computed tomography (CT) scan within 14 days of therapy.
After completion of study treatment, patients are followed up every 6 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorElias Jabbour