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

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT04065399
Trial Phases:	Phase I Phase II	Protocol IDs:	SNDX-5613-0700 (primary) NCI-2019-07963
Eligibility:	30 Days and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Syndax Pharmaceuticals
NCI Full Details:	http://clinicaltrials.gov/show/NCT04065399

Summary

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 3 indication-specific expansion cohorts to
determine the efficacy, short- and long-term safety, and tolerability of revumenib.

Objectives

Phase 1: Oral revumenib; sequential cohorts of escalating dose levels of revumenib to
identify the MTD and RP2D. Participants will be enrolled in one of six dose-escalation
arms:

Arm A: Participants not receiving any strong cytochrome P450 3A4 (CYP3A4)
inhibitor/inducers or fluconazole.

Arm B: Participants receiving itraconazole, ketoconazole, posaconazole, or voriconazole
(strong CYP3A4 inhibitors) for antifungal prophylaxis.

Arm C: Participants receiving revumenib and cobicistat.

Arm D: Participants receiving fluconazole (moderate CYP3A4 inhibitor) for antifungal
prophylaxis.

Arm E: Participants not receiving any weak, moderate, or strong CYP3A4
inhibitors/inducers.

Arm F: Participants receiving isavuconazole (moderate CYP3A4 inhibitor) for antifungal
prophylaxis.

In Phase 2, participants will be enrolled in 3 indication-specific expansion cohorts to
determine the efficacy, short- and long-term safety, and tolerability of revumenib:

- Cohort 2A: Participants with KMT2Ar acute lymphoblastic leukemia (ALL)/mixed
phenotype acute leukemia (MPAL)

- Cohort 2B: Participants with KMT2A AML

- Cohort 2C: Participants with NPM1m AML

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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