Actively Recruiting
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Led by Syndax Pharmaceuticals · Updated on 2026-03-18
447
Participants Needed
57
Research Sites
423 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have active acute leukemia with 5% or more bone marrow blasts or reappearance of blasts in peripheral blood, including those with KMT2A rearrangement, NUP98 rearrangement, or NPM1 mutation.
- Participants in Phase 1 are assigned to one of six arms based on use of CYP3A4 inhibitors/inducers or fluconazole and may receive revumenib with or without cobicistat.
- Participants in Phase 2 must have documented relapsed or refractory acute leukemia matching specific genetic groups: KMT2A ALL/MPAL, KMT2A AML, NPM1 mutated AML, or acute leukemia with mutations leading to HOX/MEIS upregulation.
- White blood cell count must be below 25,000 per microliter at enrollment.
- Participants must be male or female aged at least 30 days; those receiving revumenib with cobicistat must weigh at least 35 kg; Cohort 2D participants must be at least 18 years old and weigh at least 40 kg.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky/Lansky score 50 or higher.
- Prior treatment-related toxicities must be resolved to Grade 1 or lower, except for Grade 2 neuropathy or alopecia.
- Adequate time intervals required since prior radiation therapy, stem cell transplant, immunotherapy, antileukemic therapy, hematopoietic growth factors, biologics, and steroids.
- Adequate organ function.
- Participants of childbearing potential must agree to use highly effective contraception during the study and for 120 days afterward.
You will not qualify if you...
- Participants with active acute promyelocytic leukemia.
- Participants with isolated extramedullary relapse (Phase 2 Cohorts 2A-2C only).
- Participants with active central nervous system disease.
- Participants with detectable HIV viral load within the past 6 months.
- Participants with hepatitis B or C.
- Pregnant or nursing women.
- Participants with recent serious cardiac disease or prolonged QT interval.
- Participants with gastrointestinal conditions affecting oral drug absorption or cirrhosis with Child-Pugh B or C.
- Participants with signs or symptoms of graft-versus-host disease greater than Grade 0 within 4 weeks before enrollment.
- Participants with concurrent malignancies within 2 years except certain treated skin cancers or asymptomatic low-grade lymphoma.
- Participants requiring medications known or suspected to prolong QT interval, except certain allowed supportive drugs and azoles in study arms.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 57 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Active, Not Recruiting
2
University Of California Care Medical Group - Norris Comprehensive Cancer Center And Hospital
Los Angeles, California, United States, 90033
Completed
3
Stanford Cancer Institute
Palo Alto, California, United States, 94305
Active, Not Recruiting
4
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Florida Cancer Specialists and Research Institute
Sarasota, Florida, United States, 34232
Active, Not Recruiting
6
Moffitt Cancer Center
Tampa, Florida, United States, 33162
Completed
7
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Completed
9
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
10
University of Iowa Hospital
Iowa City, Iowa, United States, 52246
Actively Recruiting
11
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
12
Washington University in St. Louis School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
13
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Completed
14
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Active, Not Recruiting
15
Montefiore Medical Center
New York, New York, United States, 10467
Actively Recruiting
16
Duke University Medical Center
Durham, North Carolina, United States, 27110
Actively Recruiting
17
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Completed
18
Ohio State University
Columbus, Ohio, United States, 43201
Actively Recruiting
19
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
20
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
21
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
22
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
Completed
23
Peter MacCallum Cancer Centre (PMCC)
Melbourne, Victoria, Australia, 3000
Active, Not Recruiting
24
Royal Melbourne Hospital (RMH)
Parkville, Victoria, Australia, 3050
Active, Not Recruiting
25
Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
26
Sir Charles Gairdner Hospital
Nedlands, Australia, 6009
Actively Recruiting
27
Royal North Shore Hospital
Saint Leonards, Australia, 2065
Actively Recruiting
28
University Health Network
Toronto, Canada, M5G 2M9
Actively Recruiting
29
The Hospital for Sick Children
Toronto, Canada
Active, Not Recruiting
30
Hospital Saint-Louis - APHP
Paris, France, 75010
Actively Recruiting
31
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac, France, 33604
Actively Recruiting
32
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
33
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif, France, 94805
Actively Recruiting
34
University Hospital Of Ulm, Universitatsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
35
Universitaetsklinikum Essen (AoR)
Essen, Germany, 45147
Withdrawn
36
Universitaetsmedizin Greifswald
Greifswald, Germany, 17475
Completed
37
Universitaetsmedizin Der Johannes
Gutenberg, Germany, 55131
Actively Recruiting
38
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
39
University of Leipzig
Leipzig, Germany, 04103
Actively Recruiting
40
Klinikum Nuernberg Nord
Nuremberg, Germany, 90419
Completed
41
Rambam Health Care Campus (RHCC)
Haifa, Israel, 3109601
Actively Recruiting
42
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
43
Hadassah Medical Center- Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
44
Galilee Medical Center
Nahariya, Israel, 2210010
Actively Recruiting
45
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
46
Sheba Medical Center
Ramat Gan, Israel, 52621
Actively Recruiting
47
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
48
Istituto Romagnolo Per Lo Studio dei tumori Dino Amadori
Meldola, Italy, 47014
Actively Recruiting
49
IRCCS-Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
50
Universita Cattolica Fondazione Policlinico Agostino Gemelli
Roma, Italy, 00168
Actively Recruiting
51
S Bortolo Hospital AULSS 8 Berica
Vicenza, Italy, 36100
Actively Recruiting
52
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania, 08661
Actively Recruiting
53
Princess Maxima Center for Pediatric Oncology
Utrecht, Netherlands, 3584 CS
Actively Recruiting
54
Hospital Centro Comprensivo de Cancer UPR
San Juan, Puerto Rico, 00935
Actively Recruiting
55
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
56
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
57
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Actively Recruiting
Research Team
S
Syndax Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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