The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL

PHASE2RecruitingINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

August 29, 2018

Primary Completion Date

July 1, 2025

Study Completion Date

July 1, 2026

Conditions
B-cell Acute Lymphoblastic Leukemia
Interventions
DIAGNOSTIC_TEST

NGS-MRD

Next generation sequencing minimal residual disease (NGS-MRD) is a test that has increased sensitivity over multichannel flow cytometry to better identify risk of key outcomes after HCT. Patients that have a pre-HCT negative NGS-MRD results may be eligible to proceed to the treatment arm of the study that uses a non-TBI conditioning regimen.

DRUG

Myeloablative allogeneic HCT with a non-TBI conditioning regimen

"Myeloablative study regimen will consist of busulfan, fludarabine and thiotepa.~day -7: Fludarabine and Busulfan day -6: Fludarabine and Busulfan day -5: Fludarabine and Busulfan day -4: Fludarabine and Busulfan day -3: Fludarabine day -2: Thiotepa day -1: Rest Day 0: Transplant"

Trial Locations (24)

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

19803

RECRUITING

Alfred I. duPont Hospital for Children - Nemours Deleware, Wilmington

28203

RECRUITING

Atrium Health - Levine Cancer Center, Charlotte

30322

RECRUITING

Children's Healthcare of Atlanta, Atlanta

32610

RECRUITING

University of Florida, Gainesville

33155

RECRUITING

Nicklaus Children's Hospital, Miami

33701

RECRUITING

Johns Hopkins All Children's Hospital, St. Petersburg

35233

RECRUITING

Children's of Alabama/University of Alabama in Birmingham(UAB), Birmingham

46202

RECRUITING

Riley Hospital for Children - Indiana University, Indianapolis

49503

RECRUITING

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids

64108

RECRUITING

Children's Mercy Hospital, Kansas City

77030

RECRUITING

The University of Texas M. D. Anderson Cancer Center, Houston

78229

RECRUITING

Methodist Healthcare System, San Antonio

80045

RECRUITING

Children's Hospital Colorado, Aurora

85016

RECRUITING

Phoenix Children's Hospital, Phoenix

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

90095

RECRUITING

UCLA Mattel Children's Hospital, Los Angeles

91010

RECRUITING

City of Hope, Duarte

94123

RECRUITING

UCSF, San Francisco

94609

RECRUITING

UCSF Benioff Children's Hospital Oakland, Oakland

06520

RECRUITING

Yale University School of Medicine, New Haven

02111

RECRUITING

Floating Hospital for Children at Tufts Medical Center, Boston

02215

RECRUITING

Dana Faber Cancer Institute/ Boston Children's Hospital, Boston

07601

RECRUITING

Hackensack University Medical Center, Hackensack

All Listed Sponsors
lead

Pediatric Transplantation & Cellular Therapy Consortium

OTHER

NCT03509961 - The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL | Biotech Hunter | Biotech Hunter