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

Conditions

• Pediatric Acute Leukemia

Eligibility Criteria

Sex

ALL

Age

6 Months - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Revumenib — DRUG
  Given by IV
• Cytrabine — DRUG
  Given by IV
• Daunorubicin — DRUG
  Given by IV

Study Details

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.

Key Dates

Start date

May 21, 2026

Status verified

Jun 2026

Primary completion

May 21, 2026

Completion

May 21, 2026

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation of Revumenib in combination with cytrabine and Daunorubicin and GO
  Treatment will be administered on an inpatient basis
• Experimental: Dose Expansion of Revumenib in combination with cytrabine and Daunorubicin and GO
  Treatment will be administered on an inpatient basis

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]