Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia
brief summary
To find out if giving blinatumomab as injections under the skin can help to control MRD and keep the disease from coming back in participants with B-cell ALL.
detailed description
Primary Objectives To evaluate the efficacy of SQ blinatumomab in participants with MRD positive B-cell ALL in morphological remission through Relapse free survival
Secondary Objectives
1. Rate of NGS MRD negativity (at a sensitivity of 10-6) after 2 cycles of therapy and cumulative rates of NGS MRD negativity (and PCR for BCR::ABL1 for Ph+ B-cell ALL) 2. Duration of sustained NGS MRD negativity at 10-6 3. 12- month sustained NGS MRD negativity at 10-6 for participants in first remission and 6-month sustained NGS MRD negativity for participants beyond first remission 4. Event free survival and modified event free survival (mEFS) 5. Overall survival 6. Toxicity