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Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
Sponsor: St. Jude Children's Research Hospital
Summary
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).
Official title: A Phase 1 Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
1 Year - 30 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-04-19
Completion Date
2027-04
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
Revumenib
Given by mouth (capsule or liquid solution) or liquid solution by Nasogastric tube (NG) or Gastrostomy tube (G-tube)
Venetoclax
Given by mouth (tablet) or by NG or G-tube
Azacitidine
Given intravenously (IV) infusion
intrathecal (IT) chemotherapy
Given intrathecal (IT)
Cytarabine
Given intrathecal (IT) as part of intrathecal (IT) chemotherapy.
Methotrexate
Given intrathecal (IT) as part of intrathecal (IT) chemotherapy.
Locations (10)
Rady Children's Hospital
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Children's Mercy Hospital of Kansas City
Kansas City, Missouri, United States
Memorial Sloan- Kettering Cancer Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
UT Southwestern/Simmons Cancer Center
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States