The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
Recruiting now · Phase 2
Conditions studied: B-cell Acute Lymphoblastic Leukemia
In brief
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).
Key facts
- Study ID
- NCT03509961
- Run by
- Pediatric Transplantation & Cellular Therapy Consortium
- People needed
- 95
- Starts
- 2018-08-29
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2025-05-04
Who can join
Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- CR2: exclude patients with history of CNS relapse (i.e. in CR2 with history of CNS isolated or combined relapse; CNS 2 will also be considered as CNS 3 for this purpose) from the treatment arm of study (can be enrolled on the observational arm).
- Patients who have received inotuzumab treatment prior to allogeneic HCT are NOT eligible for the study treatment arm. Inotuzumab treatment may increase the risk of VOD/SOS for any allogeneic HCT recipient, but could potentiate the risk for with busulfan-based myeloablation (study-directed non-TBI conditioning). All inotuzumab-treated patients are eligible for the observational arm (HCT center standard of care).
- Patients receiving non-myeloablative conditioning are not allowed on the observational arm (reduced toxicity conditioning with Flu/Mel/Thio is allowed on the observational arm).
- Pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants.
- Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded. Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no evidence or minimal evidence of non-progressive disease remaining by CT evaluation.
- Patients with active CNS leukemia or any other active site of extramedullary disease at the time of enrollment are not permitted.
- T-ALL and MPAL patients are only allowed on the observational arm.
- Patients with genetic disorders (generally marrow failure syndromes) prone to secondary AML/ALL with known poor outcome are not eligible (Fanconi Anemia, Kostmann Syndrome, Dyskeratosis Congenita, etc).
Where it is running
- Children's of Alabama/University of Alabama in Birmingham(UAB) — Birmingham, Alabama, United States (enrolling)
- Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
- City of Hope — Duarte, California, United States (enrolling)
- Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
- UCLA Mattel Children's Hospital — Los Angeles, California, United States (enrolling)
- UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (enrolling)
- UCSF — San Francisco, California, United States (enrolling)
- Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
- Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
- Alfred I. duPont Hospital for Children - Nemours Deleware — Wilmington, Delaware, United States (enrolling)
- University of Florida — Gainesville, Florida, United States (enrolling)
- Nicklaus Children's Hospital — Miami, Florida, United States (enrolling)
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (enrolling)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
- Riley Hospital for Children - Indiana University — Indianapolis, Indiana, United States (enrolling)
- Floating Hospital for Children at Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
- Dana Faber Cancer Institute/ Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
- Helen DeVos Children's Hospital at Spectrum Health — Grand Rapids, Michigan, United States (enrolling)
- Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
- Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
- Atrium Health - Levine Cancer Center — Charlotte, North Carolina, United States (enrolling)
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Methodist Healthcare System — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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