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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 6 Months – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: To determine the safety, tolerability and recommended phase II dose (RP2D) of Revumenib incombination with cytarabine and daunorubicin and Gemtuzumab ozogamicin (GO) in relapsed refractory and frontline pediatric patients with acute leukemias, with primary endpoint defined as DLT (per Section 7.5) Secondary Objective: To determine the preliminary assessment of efficacy by overall response (OR), including complete remission (CR), CR with incomplete blood count recovery and partial remission, overall survival (OS), event-free survival (EFS) and duration of response (DOR) of pediatric patients treated with this combination. Exploratory Objective: To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance.

Conditions

• Pediatric Acute Leukemia

Interventions

Type	Name	Description
DRUG	Revumenib	Given by IV
DRUG	Cytrabine	Given by IV
DRUG	Daunorubicin	Given by IV

Timeline

• Start date: 2027-12-01
• Primary completion: 2032-12-31
• Completion: 2034-12-31
• First posted: 2025-07-08
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study