A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Part of paid clinical trials in Duarte, California.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT04065399
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • revumenib — DRUG
    revumenib orally
  • cobicistat — DRUG
    Phase 1 Arm C participants will receive 150 mg cobicistat daily.

Study Details

Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.

Key Dates

Start date
Nov 5, 2019
Status verified
Mar 2026
Primary completion
Dec 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
447 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Revumenib
    Phase 1: Oral revumenib; sequential cohorts of escalating dose levels of revumenib. Participants will be enrolled in 1 of 6 dose-escalation arms: * Arm A: Participants not receiving any strong CYP3A4 inhibitor/inducers or fluconazole * Arm B: Participants receiving any strong CYP3A4 inhibitors for antifungal prophylaxis * Arm C: Participants receiving revumenib and cobicistat * Arm D: Participants receiving fluconazole for antifungal prophylaxis * Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers * Arm F: Participants receiving isavuconazole for antifungal prophylaxis Phase 2: Oral revumenib; 4 indication-specific expansion cohorts will be enrolled: * Cohort 2A: Participants with KMT2Ar ALL/MPAL * Cohort 2B: Participants with KMT2Ar AML * Cohort 2C: Participants with NPM1m AML * Cohort 2D: Participants with acute leukemia (including KMT2Ar, NPM1m, NUP98r and other acute leukemias expected to have HOX/MEIS upregulation)

Primary Outcome Measure

Number of participants with dose-limiting toxicities (DLTs) (Phase 1) [ Time Frame: Approximately 1 year ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
University Of California Care Medical Group - Norris Comprehensive Cancer Center And HospitalLos AngelesCalifornia90033-
Stanford Cancer InstitutePalo AltoCalifornia94305-
University of ColoradoAuroraColorado80045
Katelyn Anttila
[email protected]
Christine McMahon (PRINCIPAL_INVESTIGATOR)
Florida Cancer Specialists and Research InstituteSarasotaFlorida34232-
Moffitt Cancer CenterTampaFlorida33162-
Children's Healthcare of AtlantaAtlantaGeorgia30329-
Emory Winship Cancer InstituteAtlantaGeorgia30322
Feranmi Arowolo
[email protected]
Martha Arellano (PRINCIPAL_INVESTIGATOR)
The University of Chicago Medical CenterChicagoIllinois60637
Ellen Malone
[email protected]
Bukola Rinola
[email protected], [email protected]
Michael Thirman (PRINCIPAL_INVESTIGATOR)
University of Iowa HospitalIowa CityIowa52246
Chris Stamy
[email protected]
319-467-5320
David Dickens, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215-
Washington University in St. Louis School of MedicineSt LouisMissouri63110
Morgan Swanner
[email protected]
John DiPersio (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Montefiore Medical CenterNew YorkNew York10467
Aradhika Dhawan
[email protected]
Ioannis Mantzaris (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27110
Brittany DePriest (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45267-
Ohio State UniversityColumbusOhio43201
Sarah Mayne
[email protected]
614-366-7951
James Blachly (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
OHSU Knight Cancer Institute Clinical Trials
[email protected]
Elie Traer, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Robin E Blauser, BSN RN
[email protected]
215-662-2870
Thomas Greenwood
[email protected]
Alexander Perl (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute at the University of UtahSalt Lake CityUtah84112-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity Of California Care Medical Group - Norris Comprehensive Cancer Center And Hospital· Los Angeles, CAStanford Cancer Institute· Palo Alto, CAUniversity of Colorado· Aurora, COFlorida Cancer Specialists and Research Institute· Sarasota, FLMoffitt Cancer Center· Tampa, FL

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