This phase II trial studies how well blinatumomab works as maintenance therapy after donor stem cell transplant in treating patients with acute lymphoblastic leukemia. 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 NCT02807883.
PRIMARY OBJECTIVE:
I. To assess the feasibility of blinatumomab post allogeneic hematopoietic cell transplantation (HCT) as consolidation therapy in patients with B-lineage acute lymphoblastic leukemia (ALL).
SECONDARY OBJECTIVES:
I. To evaluate the progression-free survival (PFS) rate at 1-year for patients with ALL compared to
contemporary patient cohort.
II. To evaluate other efficacy endpoints such as overall survival (OS) and minimal residual disease
(MRD) negativity rate in patients treated with blinatumomab for consolidation therapy.
III. To evaluate, non-relapse mortality (NRM) and chronic graft-versus-host-disease (GVHD).
OUTLINE:
Patients receive blinatumomab intravenously (IV) continuously over weeks 1-4. Treatment repeats every 6 weeks for up to 4 courses at 3, 6, 9, and 12 months following HCT.
After completion of study treatment, patients are followed up at 2 weeks.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorPartow Kebriaei