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

PHASE1RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

June 20, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Acute Myeloid Leukemia With KMT2A RearrangementAcute Myeloid Leukemia With NPM1 Mutation
Interventions
PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Revumenib

Given PO

PROCEDURE

Transthoracic Echocardiography Test

Undergo transthoracic ECHO

Trial Locations (21)

21201

RECRUITING

University of Maryland/Greenebaum Cancer Center, Baltimore

22908

RECRUITING

University of Virginia Cancer Center, Charlottesville

27157

RECRUITING

Wake Forest University Health Sciences, Winston-Salem

27599

RECRUITING

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

28203

RECRUITING

Carolinas Medical Center/Levine Cancer Institute, Charlotte

33136

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33146

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables

33180

RECRUITING

UM Sylvester Comprehensive Cancer Center at Aventura, Aventura

33324

RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation

33442

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

45069

RECRUITING

University of Cincinnati Cancer Center-West Chester, West Chester

45219

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

60637

RECRUITING

University of Chicago Comprehensive Cancer Center, Chicago

66160

RECRUITING

University of Kansas Cancer Center, Kansas City

66205

RECRUITING

University of Kansas Clinical Research Center, Fairway

RECRUITING

University of Kansas Hospital-Westwood Cancer Center, Westwood

66211

RECRUITING

University of Kansas Hospital-Indian Creek Campus, Overland Park

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

84112

RECRUITING

Huntsman Cancer Institute/University of Utah, Salt Lake City

92868

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH