Clinical Trial

A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients

Withdrawn Phase 1
View on ClinicalTrials.gov →
Why the trial stopped
PI requested
Summary
The goal of Phase 1a of this clinical research study is to find the highest tolerable dose of revumenib that can be given in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin to patients who have acute leukemia. The goal of Phase 1b of this clinical research study is to learn if the dose of revumenib in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin found in Phase 1a can help to control the disease.
Protocol Amendment History 5 changes
critical Trial status changed: Not Yet Recruiting → Withdrawn 2026-05-30
critical Reason stopped changed: — → PI requested 2026-05-30
notable Enrollment reduced: 32 -> 0 participants 2026-05-30
notable Primary completion moved earlier: 2032-12-31 -> 2026-05-21 2026-05-30
minor Completion moved earlier: 2034-12-31 -> 2026-05-21 2026-05-30
Trial Details
NCT Number NCT07052994
Lead Sponsor M.D. Anderson Cancer Center
Conditions Pediatric Acute Leukemia
Start Date 2026-05-21
Primary Completion 2026-05-21 (estimated)
Study Completion 2026-05-21 (estimated)
Updated on ClinicalTrials.gov 2026-06-05