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

NOT_YET_RECRUITINGPHASE1

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•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age . 6 months - 21 years of age.
•2. ECOG performance status of \< 2.
•3. Phase 1a portion of the study: Relapsed/refractory AML, or MPAL per ELN/NCCN with a myeloid phenotype with KMT2Ar, NPM1c, NUP98r and UBTF-ITD.
•4. Phase 1b portion of the study: Frontline AML, or MPAL per ELN/NCCN with a myeloid phenotype with KMT2Ar, NUP98r and UBTF-ITD.
•5. WBC must be below 25,000/ ƒÊL at time of enrollment. Patients may receive cytoreduction prior to enrollment.
•6. Baseline ejection fraction must be \> 50%.
•7. Adequate hepatic function (direct bilirubin \< 2x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT \< 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT \< 5x ULN will be considered eligible).
•8. Potassium should be maintained at . 4.0 mEq/L and magnesium at \> 2.0 mg/dL. Maintenance PO supplementation should be started for patients who are below these thresholds, and Revumenib dosing instructions as provided in Table 2 should be followed.
•9. Adequate renal function (creatinine clearance .
•10. Willing and able to provide informed consent.
+3 more criteria

Exclusion Criteria

•1. Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
•2. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea for patients with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.
•3. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
•4. Patients with a concurrent active malignancy under treatment.
•5. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
•6. Female subjects who are pregnant or breast-feeding.
•7. Patient has an active uncontrolled infection.
•8. Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class .II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
•9. QTc \>450 msec for males and QTc \>470 msec for females using the Fridericia Formula.
•10. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient fs participation for the full duration of the study, or is not in the best interest of the patient to participate.
+3 more criteria

Locations (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

December 1, 2027

Primary Completion Date

December 31, 2032

Completion Date

December 31, 2034

Last Updated

March 4, 2026

Enrollment

ESTIMATED participants

Conditions

Pediatric Acute Leukemia

Interventions

Revumenib

DRUG

Cytrabine

DRUG

Daunorubicin

DRUG

Contacts

Branko Cuglievan, MD

CONTACT

(713) 563-1499 bcuglievan@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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