Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)
M.D. Anderson Cancer Center
Summary
To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.
Description
Primary Objective • To evaluate the rate of complete molecular response (CMR; undetectable BCR::ABL1 transcript by RT-PCR) in participants with newly diagnosed Ph-positive ALL and the overall response rate (complete remission + complete remission with incomplete count recovery) in participants with relapsed/refractory Ph-positive ALL Secondary Objectives * To evaluate event-free survival (EFS) * To evaluate overall survival (OS) * To evaluate MRD negativity by next-generation sequencing (NGS) at a sensitivity of 1x10-6 * To assess the safety of the regimen
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria * Diagnosis of one of the following: o Participants ≥18 years of age with newly diagnosed or relapsed/refractory Ph-positive and/or BCR::ABL1-positive ALL (includes Participants initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. Participants with newly diagnosed disease could have received one or two courses of chemotherapy with or without other TKIs and still eligible (Participants with lymphoid accelerated or blast phase CML will be evaluated separately). * Performance status ≤2 (ECOG Scale). * Adequate li…
Interventions
- DrugBlinatumomab
Given by Iv
- Drugolverembatinib
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas