NCT07178912

Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.

Detailed description

Primary Objective • To evaluate the rate of complete molecular response (CMR; undetectable BCR::ABL1 transcript by RT-PCR) in participants with newly diagnosed Ph-positive ALL and the overall response rate (complete remission + complete remission with incomplete count recovery) in participants with relapsed/refractory Ph-positive ALL Secondary Objectives * To evaluate event-free survival (EFS) * To evaluate overall survival (OS) * To evaluate MRD negativity by next-generation sequencing (NGS) at a sensitivity of 1x10-6 * To assess the safety of the regimen

Conditions

• Phase II Clinical Trial
• Blinatumomab
• Olverembatinib
• Lymphoblastic Leukemia
• Philadelphia Chromosome Positive

Interventions

Type	Name	Description
DRUG	Blinatumomab	Given by Iv
DRUG	olverembatinib	Given by PO

Timeline

• Start date: 2026-08-27
• Primary completion: 2031-09-30
• Completion: 2033-09-30
• First posted: 2025-09-17
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study