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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: Recruiting Phase 2 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Pediatric Transplantation & Cellular Therapy Consortium.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The primary objective of this study is the two Year Event-free Survival for patients with high-risk or recurrent B-ALL who proceed to HCT and who are NGS-MRD negative when treated with a non-TBI preparative regimen.
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 |
What NCT03509961 shows while recruiting
NCT03509961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 84-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (13% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Where NCT03509961's enrollment target sits among peer trials
95 7th of 21 higher than 15 of 21 other B-cell Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other B-cell Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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