A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

January 8, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Recurrent Acute Leukemia of Ambiguous LineageRecurrent Acute Lymphoblastic LeukemiaRecurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous LineageRecurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-RearrangedRecurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute LeukemiaRecurrent Mixed Phenotype Acute LeukemiaRefractory Acute Leukemia of Ambiguous LineageRefractory Acute Lymphoblastic LeukemiaRefractory Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous LineageRefractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-RearrangedRefractory Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute LeukemiaRefractory Mixed Phenotype Acute Leukemia
Interventions
PROCEDURE

Biospecimen Collection

Undergo collection of blood and CSF samples

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

DRUG

Calaspargase Pegol

Given IV

DRUG

Cytarabine

Given IV and IT

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Fludarabine Phosphate

Given IV

DRUG

Hydrocortisone Sodium Succinate

Given IT

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

DRUG

Methotrexate

Given IT

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

DRUG

Prednisolone

Given PO or via NG, NJ, ND or G-tube

DRUG

Prednisone

Given PO or via NG, NJ, ND or G-tube

DRUG

Revumenib

Given PO or via NG, NJ, ND or G-tube

DRUG

Vincristine Sulfate

Given IV

Trial Locations (84)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10065

Memorial Sloan Kettering Cancer Center, New York

12208

Albany Medical Center, Albany

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17822

Geisinger Medical Center, Danville

19104

Children's Hospital of Philadelphia, Philadelphia

19134

Saint Christopher's Hospital for Children, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20010

Children's National Medical Center, Washington D.C.

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22908

University of Virginia Cancer Center, Charlottesville

23507

Children's Hospital of The King's Daughters, Norfolk

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

29203

Prisma Health Richland Hospital, Columbia

29605

BI-LO Charities Children's Cancer Center, Greenville

30329

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta

32610

University of Florida Health Science Center - Gainesville, Gainesville

32803

AdventHealth Orlando, Orlando

32806

Arnold Palmer Hospital for Children, Orlando

32827

Nemours Children's Hospital, Orlando

33021

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood

33155

Nicklaus Children's Hospital, Miami

33607

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa

33908

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

Children's Hospital of Alabama, Birmingham

37203

The Children's Hospital at TriStar Centennial, Nashville

37232

Vanderbilt University/Ingram Cancer Center, Nashville

38105

Saint Jude Children's Research Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

40536

University of Kentucky/Markey Cancer Center, Lexington

43205

Nationwide Children's Hospital, Columbus

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

Dayton Children's Hospital, Dayton

46202

Riley Hospital for Children, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

48201

Children's Hospital of Michigan, Detroit

49007

Bronson Methodist Hospital, Kalamazoo

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

58122

Sanford Broadway Medical Center, Fargo

60611

Lurie Children's Hospital-Chicago, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

63110

Washington University School of Medicine, St Louis

63141

Mercy Hospital Saint Louis, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

68114

Children's Hospital and Medical Center of Omaha, Omaha

68198

University of Nebraska Medical Center, Omaha

75230

Medical City Dallas Hospital, Dallas

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

M D Anderson Cancer Center, Houston

78207

Children's Hospital of San Antonio, San Antonio

78723

Dell Children's Medical Center of Central Texas, Austin

80045

Children's Hospital Colorado, Aurora

87106

University of New Mexico Cancer Center, Albuquerque

89135

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas

89502

Renown Regional Medical Center, Reno

90242

Kaiser Permanente Downey Medical Center, Downey

92354

Loma Linda University Medical Center, Loma Linda

94158

UCSF Medical Center-Mission Bay, San Francisco

94609

UCSF Benioff Children's Hospital Oakland, Oakland

94611

Kaiser Permanente-Oakland, Oakland

97227

Legacy Emanuel Children's Hospital, Portland

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

72202-3591

Arkansas Children's Hospital, Little Rock

06106

Connecticut Children's Medical Center, Hartford

07601

Hackensack University Medical Center, Hackensack

08903

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick

07112

Newark Beth Israel Medical Center, Newark

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

V6H 3V4

British Columbia Children's Hospital, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

B3K 6R8

IWK Health Centre, Halifax

L8N 3Z5

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

N6A 5W9

Children's Hospital, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital for Sick Children, Toronto

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

G1V 4G2

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL), Québec

All Listed Sponsors
lead

Children's Oncology Group

NETWORK

NCT05761171 - A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia | Biotech Hunter | Biotech Hunter