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NCT03509961 · ClinicalTrials.gov registry record · Phase 2
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
A Phase 2 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Pediatric Transplantation & Cellular Therapy Consortium.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT03509961 is a Phase 2 study of B-cell Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Pediatric Transplantation & Cellular Therapy Consortium. The registered enrollment target is 95 participants, above the 84-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT03509961, a Phase 2 study of B-cell Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Pediatric Transplantation & Cellular Therapy Consortium.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
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?
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, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 84-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (13% higher). The listed sponsor is Pediatric Transplantation & Cellular Therapy Consortium, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT03509961 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Massachusetts.
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.
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).
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.
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.
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