Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
Primary Objectives • To evaluate the rate of next-generation sequencing (NGS) measurable residual disease (MRD) negativity 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 Exploratory Objectives - To characterize the role of ABL1 kinase domain mutations on treatment failure and relapse - To assess concordance/discordance between MRD assessed by PCR for BCR::ABL1 and next-generation sequencing MRD - To determine the effect of the combination regimen on immune cell subsets ;
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