drugset / Trial / NCT07052994

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

NCT07052994

Phase 1 Withdrawn M.D. Anderson Cancer Center
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-21
Primary completion
2026-05-21
Completion
2026-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Revumenib Small molecule Intravenous
Background Cytarabine Small molecule Intravenous
Background Daunorubicin Small molecule Intravenous

Indications