Actively Recruiting
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
Led by Pediatric Transplantation & Cellular Therapy Consortium · Updated on 2025-05-04
95
Participants Needed
24
Research Sites
409 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pre-HCT NGS-MRD negative
- Age between 1 and 25 years
- Diagnosed with B-ALL in first or second remission (CR1 or CR2)
- No prior allogeneic hematopoietic stem cell transplant
- Patients in CR1 or CR2 after blinatumomab treatment
- Patients in CR1 or CR2 after CAR-T cellular therapy
- Karnofsky Index or Lansky Play-Performance Scale ≥ 60% before transplant
- Ability to give informed consent if over 18 years, or have a legal guardian if under 18
- Adequate organ function within 4 weeks before preparative regimen, including:
- Pulmonary function tests (FEV1, FVC, DLCO) ≥ 50% of predicted or no dyspnea/supplemental oxygen for young children
- Renal function with creatinine clearance or GFR ≥ 60 mL/min/1.73 m2 or age/gender-based serum creatinine
- Cardiac function with shortening fraction ≥ 27% or ejection fraction ≥ 50%
- Hepatic function with AST/ALT less than 5 times upper limit of normal, conjugated bilirubin under 2.5 mg/dL unless Gilbert's Syndrome
You will not qualify if you...
- Patients in second remission with history of CNS relapse (excluded from treatment arm)
- Patients who received inotuzumab treatment before allogeneic HCT (ineligible for treatment arm)
- Patients receiving non-myeloablative conditioning (not allowed on observational arm)
- Pregnant or lactating females
- Patients with HIV or uncontrolled fungal, bacterial, or viral infections
- Patients with active CNS leukemia or other active extramedullary disease at enrollment
- T-ALL and MPAL patients are only allowed in the observational arm
- Patients with genetic disorders prone to secondary AML/ALL with poor outcomes (e.g., Fanconi Anemia, Kostmann Syndrome, Dyskeratosis Congenita)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Children's of Alabama/University of Alabama in Birmingham(UAB)
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
4
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
5
UCLA Mattel Children's Hospital
Los Angeles, California, United States, 90095
Actively Recruiting
6
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
7
UCSF
San Francisco, California, United States, 94123
Actively Recruiting
8
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Actively Recruiting
10
Alfred I. duPont Hospital for Children - Nemours Deleware
Wilmington, Delaware, United States, 19803
Actively Recruiting
11
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
12
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
13
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
14
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
15
Riley Hospital for Children - Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
16
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
17
Dana Faber Cancer Institute/ Boston Children's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
18
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
19
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
20
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
21
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
22
Atrium Health - Levine Cancer Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
23
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
24
Methodist Healthcare System
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
L
Liz Gourdine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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