Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Part of paid clinical trials in San Diego, California.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06177067
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Leukemia of Ambiguous Lineage
  • Refractory Acute Myeloid Leukemia
  • Relapsed Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    Given by mouth (capsule or liquid solution) or liquid solution by Nasogastric tube (NG) or Gastrostomy tube (G-tube)
  • Venetoclax — DRUG
    Given by mouth (tablet) or by NG or G-tube
  • Azacitidine — DRUG
    Given intravenously (IV) infusion
  • intrathecal (IT) chemotherapy — DRUG
    Given intrathecal (IT)
  • Cytarabine — DRUG
    Given intrathecal (IT) as part of intrathecal (IT) chemotherapy.
  • Methotrexate — DRUG
    Given intrathecal (IT) as part of intrathecal (IT) chemotherapy.

Study Details

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).

Key Dates

Start date
Apr 19, 2024
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Eligible Participants
    All eligible patients receive the following intervention: Revumenib, Venetoclax, Azacitidine, Intrathecal chemotherapy

Primary Outcome Measure

The safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL [ Time Frame: 43 days from the start of therapy. ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Rady Children's HospitalSan DiegoCalifornia92132
Dennis Kuo, MD
[email protected]
858-966-5811
Dennis Kuo, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Kelly Faulk, MD
[email protected]
720-777-6503
Kelly Faulk, MD (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of AtlantaAtlantaGeorgia30329
Himalee Sabnis, MD
[email protected]
404-727-3285
Himalee Sabnis, MD (PRINCIPAL_INVESTIGATOR)
Children's Mercy Hospital of Kansas CityKansas CityMissouri64108
Keith August, MD
[email protected]
816-302-6808
Keith August, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan- Kettering Cancer CenterNew YorkNew York10065
Maria-Luisa Sulis, MD
[email protected]
212-639-5175
Maria-Luisa Sulis, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Lauren Pommert, MD
[email protected]
513-803-9083
Lauren Pommert, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Sarah Tasian, MD
[email protected]
267-425-0118
Sarah Tasian, MD (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee38105
Hiroto Inaba, MD, PhD
[email protected]
888-226-4343
Hiroto Inaba, MD, PhD (PRINCIPAL_INVESTIGATOR)
UT Southwestern/Simmons Cancer CenterDallasTexas75390
Kathleen Ludwig, MD
[email protected]
214-456-6927
Kathleen Ludwig, MD (PRINCIPAL_INVESTIGATOR)
Cook Children's Medical CenterFort WorthTexas76104
Holly Pacenta, MD
[email protected]
682-885-4007
Holly Pacenta, MD (PRINCIPAL_INVESTIGATOR)

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Rady Children's Hospital· San Diego, CAChildren's Hospital Colorado· Aurora, COChildren's Healthcare of Atlanta· Atlanta, GAChildren's Mercy Hospital of Kansas City· Kansas City, MOMemorial Sloan- Kettering Cancer Center· New York, NYCincinnati Children's Hospital Medical Center· Cincinnati, OH

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