Actively Recruiting
A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias
Led by Syndax Pharmaceuticals · Updated on 2026-02-17
76
Participants Needed
46
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.
CONDITIONS
Official Title
A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years with newly diagnosed acute myeloid leukemia confirmed by WHO 2022 criteria
- Untreated AML and eligible for intensive chemotherapy
- Presence of KMT2A rearrangement, NPM1 mutation, or NUP98 rearrangement confirmed by local lab before starting treatment
- Eastern Cooperative Oncology Group performance status of 0 to 2 (or 0 to 1 if over 65 years old)
- Adequate liver, kidney, and heart function
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Active central nervous system leukemia
- Corrected QT interval over 450 milliseconds or history of Long QT syndrome
- Gastrointestinal conditions affecting oral drug absorption
- Cirrhosis with Child-Pugh score B or C
- Recent (within 6 months) serious heart conditions such as myocardial infarction, unstable angina, heart failure class II or higher, uncontrolled arrhythmia, stroke, or transient ischemic attack
- Active hepatitis B, hepatitis C, or HIV infection with detectable viral load
- Active uncontrolled infection
- Uncontrolled disseminated intravascular coagulation
- Pregnancy or breastfeeding
- Use of prohibited chemotherapy, radiation, or immunotherapy
- Use of strong CYP3A4 inducers or inhibitors except specified antifungal drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
UCLA Medical Hematology
Burbank, California, United States, 91505
Actively Recruiting
2
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
AdventHealth Blood & Marrow Transplant Center
Orlando, Florida, United States, 32804
Actively Recruiting
4
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
5
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
University of Louisville Health Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
8
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States, 40207
Actively Recruiting
9
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Allina Health Cancer Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
12
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
13
Institution name: Northwell Health-Brany
Lake Success, New York, United States, 11042
Actively Recruiting
14
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
15
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
16
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
17
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
18
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
19
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
Oregon Health and Science University- Center for Hematologic Malignancies
Portland, Oregon, United States, 97239
Actively Recruiting
21
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
22
MUSC Hollings Cancer Center (HCC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
23
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
24
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
25
LDS Hospital - Intermountain Healthcare
Salt Lake City, Utah, United States, 84143
Actively Recruiting
26
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
27
Northern Hospital, Victoria
Epping, Victoria, Australia, 3076
Actively Recruiting
28
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
29
Royal Adelaide Hospital
Adelaide, Australia, SA 5000
Actively Recruiting
30
The Alfred Hospital, Victoria
Melbourne, Australia, 3004
Actively Recruiting
31
Sir Charles Gairdner Hospital
Nedlands, Australia, 6009
Actively Recruiting
32
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
33
Gordon and Leslie Diamond Health Care Center
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
34
The Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
35
University Medical Center Utrecht
Utrecht, Netherlands, 3584
Actively Recruiting
36
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
37
Hospital Clinic de Barcelona
Barcelona, Spain, 8036
Actively Recruiting
38
Hospital San Pedro de Alcantara
Cáceres, Spain, 10003
Actively Recruiting
39
Hospital Universitario Virgen de Las Nieves
Granada, Spain, 18014
Actively Recruiting
40
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
41
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
42
Hospital Universitario De Salamanca
Salamanca, Spain, 37007
Actively Recruiting
43
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41013
Actively Recruiting
44
Universitat de Valencia
Valencia, Spain, 46026
Actively Recruiting
45
Hammersmith Hospital
London, London, City of, United Kingdom, W12 0HS
Actively Recruiting
46
The Royal Marsden NHS
Sutton, United Kingdom, SM2 5PT
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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