Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

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

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