Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
NCT03509961 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST NGS-MRD
- DRUG Myeloablative allogeneic HCT with a non-TBI conditioning regimen
Study Locations (20)
California
- City of Hope — Duarte
- Children's Hospital Los Angeles — Los Angeles
- UCLA Mattel Children's Hospital — Los Angeles
- UCSF Benioff Children's Hospital Oakland — Oakland
- UCSF — San Francisco
Florida
- University of Florida — Gainesville
- Nicklaus Children's Hospital — Miami
- Johns Hopkins All Children's Hospital — St. Petersburg
Massachusetts
- Floating Hospital for Children at Tufts Medical Center — Boston
- Dana Faber Cancer Institute/ Boston Children's Hospital — Boston
Alabama
- Children's of Alabama/University of Alabama in Birmingham(UAB) — Birmingham
Arizona
- Phoenix Children's Hospital — Phoenix
Colorado
- Children's Hospital Colorado — Aurora
Connecticut
- Yale University School of Medicine — New Haven
Delaware
- Alfred I. duPont Hospital for Children - Nemours Deleware — Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03509961
The ClinicalTrials.gov registry entry for NCT03509961 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pediatric Transplantation & Cellular Therapy Consortium, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with B-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 2 interventions — of which NGS-MRD is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03509961 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03509961 about?
NCT03509961 is a clinical study titled "The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL". 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 ...
What is the current status of trial NCT03509961?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2018-08-29. Estimated completion is 2026-07-01.
What conditions does trial NCT03509961 study?
This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03509961?
The interventions under investigation include: NGS-MRD (DIAGNOSTIC_TEST), Myeloablative allogeneic HCT with a non-TBI conditioning regimen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03509961?
This trial is sponsored by Pediatric Transplantation & Cellular Therapy Consortium, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03509961 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.