NCT07283640

A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed/refractory Ph-negative ALL with a KMT2A rearrangement.

Detailed description

Primary Objectives * To determine the safety of recommended dose by 20 participants including 10 relapsed/refractory participants (cohort 1) and 10 newly diagnosed participants (cohort 2). * To evaluate the overall response rate (combination of complete remission \[CR\] + complete remission with incomplete count recovery \[CRi) + complete remission with incomplete hematologic recovery \[CRh\]) of the combination of SC blinatumomab and revumenib in cohort 1 and cohort 2 (participants with MRD-only disease will not be included towards the overall response rate) * To evaluate event-free survival (EFS, defined as the time from treatment initiation to relapse, death, or documented treatment failure) in cohort 2 Secondary Objectives * To evaluate overall survival (OS, defined as the time from treatment initiation to death from any cause) * To summarize the safety of the combination of revumenib and SC blinatumomab at all revumenib doses tested * To evaluate measurable residual disease (MRD) negativity by flow cytometry (sensitivity of 10-4) and ClonoSeq NGS (sensitivity of 10-6) * To characterize the frequency of lineage switch after treatment with the combination of revumenib and SC blinatumomab

Conditions

• Blinatumomab
• Revumenib
• Lymphoblastic Leukemia
• KMT2A-rearranged

Interventions

Type	Name	Description
DRUG	Revumenib	Given by po
DRUG	Blinatumomab	Given by IV

Timeline

• Start date: 2026-05-18
• Primary completion: 2029-08-31
• Completion: 2031-08-31
• First posted: 2025-12-16
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study