Actively Recruiting
Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
28
Participants Needed
22
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL/KMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone.
CONDITIONS
Official Title
Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-75 years with newly diagnosed NPM1-mutated/FLT3 wild type or MLL(KMT2A)-rearranged acute myeloid leukemia
- Candidates for intensive induction chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky score ≥ 60%)
- Total bilirubin ≤ 2 times the upper limit of normal (ULN), except Gilbert's syndrome
- AST/ALT ≤ 3 times ULN
- Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m²
- HIV patients on effective antiretroviral therapy with undetectable viral load within 6 months
- Patients with controlled hepatitis B or treated hepatitis C infection
- Patients with prior or concurrent malignancies that do not interfere with safety or efficacy assessment
- Cardiac function assessed as New York Heart Association class 2B or better
- Ejection fraction ≥ 50% (or ≥ 45% if no heart failure symptoms) by ECHO or MUGA
- White blood cell count less than 25 x 10⁹/L; hydroxyurea/leukapheresis allowed prior to enrollment but stopped 24 hours before treatment
- Female patients of childbearing potential must use two forms of contraception from screening until 120 days after last treatment dose
- Male patients with partners of childbearing potential must abstain or use two forms of contraception during the same period
- No prior AML treatment except hydroxyurea or all-trans retinoic acid (if APL ruled out)
- Ability to understand and sign informed consent (legally authorized representatives may consent)
You will not qualify if you...
- Allergic reactions to SNDX-5613, daunorubicin, or cytarabine
- Uncontrolled illnesses making participation unsafe
- Use of strong/moderate CYP3A4 inhibitors or inducers (except antifungals) or sensitive MATE1 substrates within 7 days before enrollment
- Pregnancy or breastfeeding
- Isolated myeloid sarcoma without blood or marrow involvement
- Acute promyelocytic leukemia (FAB M3)
- Active central nervous system involvement by AML
- Uncontrolled bleeding or thrombosis due to coagulopathy
- QTcF ≥ 450 ms or risk factors for arrhythmia unless cleared by cardiology
- Exceeding lifetime anthracycline exposure limits
- Upper gastrointestinal conditions affecting oral drug absorption
- Cirrhosis with Child-Pugh score B or C
- Down Syndrome due to increased chemotherapy toxicity risk
- Myelodysplastic syndromes treated with intensive induction similar to 7+3 chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
2
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Suspended
3
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
4
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
5
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
6
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
7
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
8
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
9
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
10
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
11
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
12
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
13
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
14
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
15
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
16
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
17
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
18
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
19
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
20
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
21
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
22
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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