At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed relapsed or refractory Ph+ B-cell ALL with measurable bone marrow lymphoblasts or biopsy-proven extramedullary disease
- ✓Ph+ patients must have failed treatment with at least one second-generation tyrosine kinase inhibitor
- ✓Prior allo-HCT allowed if ≥3 months from enrollment
- ✓Karnofsky performance status ≥60%
- ✕Diagnosis of T-ALL or Burkitt's leukemia/lymphoma
- ✕Current evidence of active CNS leukemia
- ✕Prior treatment with ibrutinib or blinatumomab
- ✕Allo-HCT within 3 months of enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of Ibrutinib and Blinatumomab in Relapsed and Refractory B-Cell Acute Lymphoblastic Leukemia
In Brief
A Phase 2 clinical trial evaluating Blinatumomab and Ibrutinib for Adult B Acute Lymphoblastic Leukemia and Philadelphia Chromosome Positive. Completed, enrolled 19 participants across 2 sites.
Signals
Detailed Summary
This phase II trial studies how well ibrutinib and blinatumomab work in treating patients with B acute lymphoblastic leukemia that has come back or is not responding to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of cancer cells to grow and spread. Giving ibrutinib and blinatumomab may work better in treating patients with relapsed or refractory B acute lymphoblastic leukemia.
Study Details
Timeline
Arms & Interventions
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given PO