Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia
M.D. Anderson Cancer Center
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.
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 a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants of age ≥18 years with documented B-cell ALL with recurrent or persistent MRD (at a sensitivity of 10-6) while in morphological remission (Includes Ph-, Ph+ and Ph-like). * ECOG Performance status of 0, 1, or 2. * Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg/dl and ALT and/or AST less than or equal to 5 times institutional upper limit of normal. * The effects of blinatumomab on the developing human fetus are unknown. For this reason and because bispecific T-cell engager agents as well as other…
Interventions
- DrugBlinatumomab
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas