Spots Global Cancer Trial Database for Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Official Title: Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Study ID: NCT06308588
Study Description
Brief Summary: To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
Detailed Description: 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Nicholas Short, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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