Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

June 5, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Acute Leukemia of Ambiguous LineageB Acute Lymphoblastic Leukemia
Interventions
DRUG

Asparaginase Erwinia chrysanthemi

Given recombinant crisantaspase IM or crisantaspase IM or IV

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

BIOLOGICAL

Blinatumomab

Given IV

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

DRUG

Calaspargase Pegol

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT or IV

DRUG

Daunorubicin

Given IV

DRUG

Dexamethasone

Given PO or NG or IV

DRUG

Doxorubicin

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET

DRUG

Leucovorin

Given PO or NG or IV

DRUG

Levoleucovorin

Given IV

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Mercaptopurine

Given PO or NG

DRUG

Methotrexate

Given IT or IV or PO or NG

DRUG

Methylprednisolone

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Prednisolone

Given PO or NG

DRUG

Prednisone

Given PO or NG

DRUG

Therapeutic Hydrocortisone

Given IT

DRUG

Thioguanine

Given PO or NG

DRUG

Venetoclax

Given PO or NG

DRUG

Vincristine

Given IV

Trial Locations (78)

10016

RECRUITING

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

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

RECRUITING

NYP/Weill Cornell Medical Center, New York

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

10595

RECRUITING

New York Medical College, Valhalla

12208

RECRUITING

Albany Medical Center, Albany

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

14642

RECRUITING

University of Rochester, Rochester

15224

RECRUITING

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17822

RECRUITING

Geisinger Medical Center, Danville

18103

RECRUITING

Lehigh Valley Hospital-Cedar Crest, Allentown

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19803

RECRUITING

Alfred I duPont Hospital for Children, Wilmington

20010

RECRUITING

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

21215

RECRUITING

Sinai Hospital of Baltimore, Baltimore

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22908

RECRUITING

University of Virginia Cancer Center, Charlottesville

23507

RECRUITING

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

27157

RECRUITING

Wake Forest University Health Sciences, Winston-Salem

27834

RECRUITING

East Carolina University, Greenville

28203

RECRUITING

Carolinas Medical Center/Levine Cancer Institute, Charlotte

29203

RECRUITING

Prisma Health Richland Hospital, Columbia

29605

RECRUITING

BI-LO Charities Children's Cancer Center, Greenville

30329

RECRUITING

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

32207

RECRUITING

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

RECRUITING

University of Florida Health Science Center - Gainesville, Gainesville

32803

RECRUITING

AdventHealth Orlando, Orlando

32806

RECRUITING

Arnold Palmer Hospital for Children, Orlando

32827

RECRUITING

Nemours Children's Hospital, Orlando

33021

RECRUITING

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

33607

RECRUITING

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

37203

RECRUITING

The Children's Hospital at TriStar Centennial, Nashville

37232

RECRUITING

Vanderbilt University/Ingram Cancer Center, Nashville

37916

RECRUITING

East Tennessee Childrens Hospital, Knoxville

38105

RECRUITING

Saint Jude Children's Research Hospital, Memphis

39216

RECRUITING

University of Mississippi Medical Center, Jackson

40202

RECRUITING

Norton Children's Hospital, Louisville

40536

RECRUITING

University of Kentucky/Markey Cancer Center, Lexington

43606

RECRUITING

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo

44106

RECRUITING

Rainbow Babies and Childrens Hospital, Cleveland

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

RECRUITING

Riley Hospital for Children, Indianapolis

48109

RECRUITING

C S Mott Children's Hospital, Ann Arbor

49007

RECRUITING

Bronson Methodist Hospital, Kalamazoo

49503

RECRUITING

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids

53226

RECRUITING

Children's Hospital of Wisconsin, Milwaukee

54301

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

55455

RECRUITING

University of Minnesota/Masonic Cancer Center, Minneapolis

60611

RECRUITING

Lurie Children's Hospital-Chicago, Chicago

62702

RECRUITING

Southern Illinois University School of Medicine, Springfield

63141

RECRUITING

Mercy Hospital Saint Louis, St Louis

64108

RECRUITING

Children's Mercy Hospitals and Clinics, Kansas City

68114

RECRUITING

Children's Hospital and Medical Center of Omaha, Omaha

70118

RECRUITING

Children's Hospital New Orleans, New Orleans

70121

RECRUITING

Ochsner Medical Center Jefferson, New Orleans

75230

RECRUITING

Medical City Dallas Hospital, Dallas

75390

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

77030

RECRUITING

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

78207

RECRUITING

Children's Hospital of San Antonio, San Antonio

78229

RECRUITING

Methodist Children's Hospital of South Texas, San Antonio

78723

RECRUITING

Dell Children's Medical Center of Central Texas, Austin

79905

RECRUITING

El Paso Children's Hospital, El Paso

80045

RECRUITING

Children's Hospital Colorado, Aurora

83712

RECRUITING

Saint Luke's Cancer Institute - Boise, Boise

92354

RECRUITING

Loma Linda University Medical Center, Loma Linda

94611

RECRUITING

Kaiser Permanente-Oakland, Oakland

98105

RECRUITING

Seattle Children's Hospital, Seattle

99204

RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital, Spokane

99508

RECRUITING

Providence Alaska Medical Center, Anchorage

72202-3591

RECRUITING

Arkansas Children's Hospital, Little Rock

06106

RECRUITING

Connecticut Children's Medical Center, Hartford

04074

RECRUITING

Maine Children's Cancer Program, Scarborough

01655

RECRUITING

UMass Memorial Medical Center - University Campus, Worcester

03756

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

08903

RECRUITING

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

07503

RECRUITING

Saint Joseph's Regional Medical Center, Paterson

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

00926

RECRUITING

University Pediatric Hospital, San Juan

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT06317662 - Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia | Biotech Hunter | Biotech Hunter