The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
Start Date
8/29/2018
Completion Date
7/1/2026
Summary
This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center standard and will be followed in an observational cohort (HCT center standard of care).
Detailed Description
A Phase II pilot trial will estimate survival after a non-TBI based conditioning regimen in patients diagnosed with B-acute lymphoblastic leukemia (ALL) who are pre-allogeneic hematopoietic cell transplantation (HCT) next-generation-sequence (NGS) minimal residual disease (MRD) negative. The relationship of NGS-MRD status to survival in children, adolescents, and young adults with B-ALL undergoing any approach to allogeneic HCT will be explored in a larger cohort (treatment \[phase II\] and observational arms of the study). The primary objective is to estimate 2-year event free survival (EFS) in pre-HCT NGS-MRD negative patients with B-ALL undergoing a non-TBI based conditioning regimen through a multi-center prospective trial. The accrual period is 3 years. Patients that are NGS-MRD negative with B-ALL may be eligible for the Treatment Arm, which is myeloablative non-TBI conditioning with busulfan, fludarabine, and thiotepa followed -matched related, unrelated, and umbilical cord blood transplants. Patients that are NGS-MRD positive will be followed on the observational arm for outcome. Study sampling will include NGS-MRD bone marrow (BM) aspirate and peripheral blood (PB) samples collected \[same day when possible\] pre-HCT (within 4 weeks), and post-HCT on days 42 ± 14, 100 ± 20, and 365 ± 60; PB samples only will also be collected day 180± 60 and 270± 60; day +30, day +100, and 1-year post-HCT. NGS-MRD peripheral blood sample only at 6 months and 9 months post-HCT; (Blast specimen at time of diagnosis or relapse is required for NGS-MRD testing).
Eligibility Criteria
Age Range: 1 years to 25 years
Interventions
NGS-MRD
Myeloablative allogeneic HCT with a non-TBI conditioning regimen
Conditions
Locations
Children's of Alabama/University of Alabama in Birmingham(UAB)
Birmingham, Alabama 35233
United States
Phoenix Children's Hospital
Phoenix, Arizona 85016
United States
City of Hope
Duarte, California 91010
United States
Children's Hospital Los Angeles
Los Angeles, California 90027
United States
UCLA Mattel Children's Hospital
Los Angeles, California 90095
United States
UCSF Benioff Children's Hospital Oakland
Oakland, California 94609
United States
UCSF
San Francisco, California 94123
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Yale University School of Medicine
New Haven, Connecticut 06520
United States
Alfred I. duPont Hospital for Children - Nemours Deleware
Wilmington, Delaware 19803
United States
University of Florida
Gainesville, Florida 32610
United States
Nicklaus Children's Hospital
Miami, Florida 33155
United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida 33701
United States
Children's Healthcare of Atlanta
Atlanta, Georgia 30322
United States
Riley Hospital for Children - Indiana University
Indianapolis, Indiana 46202
United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts 02111
United States
Dana Faber Cancer Institute/ Boston Children's Hospital
Boston, Massachusetts 02215
United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan 49503
United States
Children's Mercy Hospital
Kansas City, Missouri 64108
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Atrium Health - Levine Cancer Center
Charlotte, North Carolina 28203
United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas 77030
United States
Methodist Healthcare System
San Antonio, Texas 78229
United States