NCT06308588

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.

Detailed 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

Conditions

• Philadelphia Chromosome-Positive
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	Given by Infusion
DRUG	Asciminib	Given by PO

Timeline

• Start date: 2024-08-05
• Primary completion: 2027-05-01
• Completion: 2029-05-01
• First posted: 2024-03-13
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study