Actively Recruiting
Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
Led by St. Jude Children's Research Hospital · Updated on 2026-05-04
24
Participants Needed
10
Research Sites
153 weeks
Total Duration
On this page
Sponsors
S
St. Jude Children's Research Hospital
Lead Sponsor
S
Syndax Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug. Primary Objective * To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL. Secondary Objectives * Describe the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and overall survival for patients treated with revumenib + azacitidine + venetoclax at the recommended phase 2 dose (RP2D).
CONDITIONS
Official Title
Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL)
- Refractory leukemia after at least two induction chemotherapy courses or relapsed leukemia after remission with specified blast percentages in bone marrow or blood
- Presence of specific genetic rearrangements or mutations such as KMT2A, NUP98, NPM1, PICALM::MLLT10, DEK::NUP214, UBTF-TD, KAT6A, or SET::NUP214
- Adequate organ function including bilirubin, creatinine clearance, and heart function
- QTcF less than 480 milliseconds
- Age between 1 and 30 years
- Lansky score 60 or higher if under 16 years, Karnofsky score 60% or higher if 16 years or older
- At least 14 days or 5 half-lives since last myelosuppressive therapy with resolved toxicities
- Leukocyte count less than 25,000 cells/uL, with allowable low-dose therapy to achieve this
- For prior stem cell transplant patients, no graft-versus-host disease and required time elapsed since transplant and immunosuppressive drugs
- Use of posaconazole or voriconazole started at least 24 hours before therapy
- Agreement to use effective contraception if of reproductive potential
You will not qualify if you...
- Pregnancy or breastfeeding
- Diagnosis of Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes
- Uncontrolled infection
- Patients with infections controlled by antimicrobial agents are allowed
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Rady Children's Hospital
San Diego, California, United States, 92132
Actively Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
4
Children's Mercy Hospital of Kansas City
Kansas City, Missouri, United States, 64108
Actively Recruiting
5
Memorial Sloan- Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
8
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
9
UT Southwestern/Simmons Cancer Center
Dallas, Texas, United States, 75390
Actively Recruiting
10
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
Research Team
H
Hiroto Inaba, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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