Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
M.D. Anderson Cancer Center
Summary
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
Description
Primary Objectives * Phase I: To determine the minimum safe and biologically effective dose of asciminib in combination with blinatumomab * Phase II: To evaluate the rate of NGS measurable residual disease (MRD) negativity using the clonoSEQ® assay in cohort 1 (newly diagnosed Ph-positive ALL) and the overall response (CR+CRi) rate in cohort 2 (relapsed/refractory disease). Secondary Objectives * To evaluate other clinical efficacy endpoints (complete molecular response \[CMR\] rate, CR rate, relapse-free survival and overall survival) * To determine the safety of the combination regimen E…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of one of the following: a) Participants ≥18 years of age with previously untreated or minimally pretreated Ph-positive ALL who are not suitable candidates for intensive chemotherapy. Participants who have received no more than one or two courses of chemotherapy with or without other TKIs are considered minimally pretreated and still eligible if they have persistently detectable MRD. i. If they are in morphologic remission at enrollment, they are evaluable only MRD responses, RFS and OS b) Participants ≥ 12 years of age with relapsed/refractory Ph-posi…
Interventions
- DrugBlinatumomab
Given by Infusion
- DrugAsciminib
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas