A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia

Part of paid clinical trials in San Francisco, California.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT05326516
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Days - N/A
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    Participants will receive revumenib until meeting criteria for discontinuation.
  • Chemotherapy Regimen 1 — DRUG
    Participants will receive 2 treatment cycles of chemotherapy. During Cycle 1, participants will receive prednisone, vincristine, pegaspargase/calaspargase pegol-mknL, and daunorubicin. During Cycle 2, participants will receive etoposide and cyclophosphamide.
  • Chemotherapy Regimen 2 — DRUG
    Participants will receive 2 treatment cycles of chemotherapy. During Cycles 1 and 2, participants will receive fludarabine and cytarabine.

Study Details

The purpose of this study is to determine the safety and tolerability of revumenib when given in combination with 2 different chemotherapy regimens in participants with relapsed/refractory acute leukemias harboring KMT2A rearrangement, KMT2A amplification, NPM1c, or NUP98r.

Key Dates

Start date
Mar 9, 2022
Status verified
Aug 2024
Primary completion
Jul 29, 2024
Completion
Jul 29, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Revumenib and Chemotherapy Regimen 1
    Participants with acute lymphoblastic leukemia/mixed phenotype acute leukemia (ALL/MPAL) will receive revumenib every 12 hours in combination with 2 treatment cycles of Chemotherapy Regimen 1.
  • Experimental: Revumenib and Chemotherapy Regimen 2
    Participants with ALL/MPAL or acute myeloid leukemia (AML) will receive revumenib every 12 hours in combination with 2 treatment cycles of Chemotherapy Regimen 2.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities From Revumenib [ Time Frame: Day 1 through up to 30 days after last dose of study intervention ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, San Francisco (UCSF) Benioff Children's HospitalSan FranciscoCalifornia94158-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Children's Mercy HospitalKansas CityMissouri64108-
Washington University School of MedicineSt LouisMissouri63110-
David H Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
St. Jude Children's Research Hospital, IncMemphisTennessee38105-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Children's Cancer and Hematology CenterHoustonTexas77030-

Find similar trials in San Francisco, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of California, San Francisco (UCSF) Benioff Children's Hospital· San Francisco, CADana-Farber Cancer Institute· Boston, MAChildren's Mercy Hospital· Kansas City, MOWashington University School of Medicine· St Louis, MODavid H Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center· New York, NYCincinnati Children's Hospital Medical Center· Cincinnati, OH

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