Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

435

Participants

Timeline

Start Date

March 15, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic Syndrome
Interventions
PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

DRUG

Busulfan

Given intravenously (IV)

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Fludarabine

Given IV

PROCEDURE

Haploidentical Hematopoietic Cell Transplantation

Undergo haploHCT

BIOLOGICAL

Lapine T-Lymphocyte Immune Globulin

Given IV

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Matched Unrelated Donor Hematopoietic Cell Transplantation

Undergo MUD-HCT

DRUG

Melphalan

Given IV

DRUG

Methotrexate

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Mycophenolate Mofetil

Given IV

PROCEDURE

Myeloablative Conditioning

Receive myeloablative conditioning regimen

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Rituximab

Given IV

PROCEDURE

T-Cell Depletion Therapy

Undergo haploHCT with alpha beta T cell depletion

DRUG

Tacrolimus

Given IV

DRUG

Thiotepa

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

Trial Locations (63)

2145

The Children's Hospital at Westmead, Westmead

10016

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

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

10595

New York Medical College, Valhalla

11040

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

17033

Penn State Children's Hospital, Hershey

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

23298

VCU Massey Comprehensive Cancer Center, Richmond

27710

Duke University Medical Center, Durham

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

29425

Medical University of South Carolina, Charleston

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

University of Florida Health Science Center - Gainesville, Gainesville

32803

AdventHealth Orlando, Orlando

33136

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

33155

Nicklaus Children's Hospital, Miami

33701

Johns Hopkins All Children's Hospital, St. Petersburg

35233

Children's Hospital of Alabama, Birmingham

37203

The Children's Hospital at TriStar Centennial, Nashville

37232

Vanderbilt University/Ingram Cancer Center, Nashville

39216

University of Mississippi Medical Center, Jackson

40202

Norton Children's Hospital, Louisville

44195

Cleveland Clinic Foundation, Cleveland

46202

Riley Hospital for Children, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

48201

Children's Hospital of Michigan, Detroit

49503

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

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

55905

Mayo Clinic in Rochester, Rochester

60611

Lurie Children's Hospital-Chicago, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

63110

Washington University School of Medicine, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

70118

Children's Hospital New Orleans, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

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

78229

Methodist Children's Hospital of South Texas, San Antonio

80045

Children's Hospital Colorado, Aurora

84113

Primary Children's Hospital, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

91010

City of Hope Comprehensive Cancer Center, Duarte

92354

Loma Linda University Medical Center, Loma Linda

94158

UCSF Medical Center-Mission Bay, San Francisco

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

94609

UCSF Benioff Children's Hospital Oakland, Oakland

72202-3591

Arkansas Children's Hospital, Little Rock

06520

Yale University, New Haven

07601

Hackensack University Medical Center, Hackensack

T3B 6A8

Alberta Children's Hospital, Calgary

V6H 3V4

British Columbia Children's Hospital, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

M5G 1X8

Hospital for Sick Children, Toronto

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

All Listed Sponsors
lead

Children's Oncology Group

NETWORK