The EndRAD Trial: Eliminating Total Body Irradiation for B-ALL
This study, called the EndRAD Trial, is for children, adolescents, and young adults (ages 1 to 25) with B-cell Acute Lymphoblastic Leukemia (B-ALL) who are candidates for a stem cell transplant (HCT). It aims to see if a special test, called NGS-MRD (next generation sequencing minimal residual disease), can help identify patients who might not need total body irradiation (TBI) before their transplant. If your NGS-MRD test before transplant is negative, you might be eligible for a treatment that uses a different conditioning regimen with busulfan, fludarabine, and thiotepa instead of TBI. The main goal is to see how many patients are free from events (like relapse) two years after this treatment. Patients with a positive NGS-MRD test will be observed.
- Study design
- This is an interventional study planning to enroll 95 participants. It is a Phase II pilot trial.
- What's involved
- You would undergo an NGS-MRD test before your transplant. If eligible, you would receive a specific conditioning regimen over several days before your transplant.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your event-free survival will be measured at two years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03509961
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
Recruiting
PHASE2Ages 1–25InterventionalTreatmentPediatric Transplantation & Cellular Therapy ConsortiumInvestigator-initiated
~95 participants
Updated 2025-05-04 on ClinicalTrials.gov
What's tested:NGS-MRDMyeloablative allogeneic HCT with a non-TBI conditioning regimen
At a glance
Recruiting sites
24 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Two Year Event-free Survival
Measured over Two years
Conditions
Where it's being run
24 sites across 16 statesCalifornia5
Florida3
Massachusetts2
Texas2
Alabama1
Arizona1
Colorado1
Connecticut1
Study leadership
- Abdel-Azim Hisham, MD · PRINCIPAL_INVESTIGATOR · Loma Linda University
- Troy Quigg, DO, MS · PRINCIPAL_INVESTIGATOR · Helen DeVos Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patients who are pre-HCT NGS-MRD positive.
Patients \<1 year old who are pre-HCT NGS-MRD negative.
Patients who are pre-HCT NGS-MRD negative (CR1/CR2) who received inotuzumab ozogamicin therapy before proceeding to HCT.
Patients who are pre-HCT NGS-MRD negative and will be receiving haploidentical HCT.
Patients who are pre-HCT NGS-MRD negative in CR2 with history of CNS relapse.
Patients who have received blinatumomab, but are \>CR2 prior to HCT.
Patients who have received CART-T cellular therapy, but are \>CR2 prior to HCT.
Patients with pre-HCT NGS-MRD negative in ≥ CR3.
Any T-ALL and MPAL patients undergoing first allogeneic HCT
Any patient who is pre-HCT NGS-MRD negative and eligible for participation in the treatment arm but family does not consent for treatment arm or treating physician believe it is in the patient best interest not to enroll on the treatment arm
Pre-HCT NGS-MRD negative
Age ≥ 1 year and ≤ 25 years
Disease status: B-ALL in first (CR1) or second remission (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 % on pre-transplant evaluation. Karnofsky scores must be used for patients \> 16 years of age and Lansky scores for patients \< 16 years of age.
Able to give informed consent if \> 18 years, or with a legal guardian capable of giving informed consent if \< 18 years.
Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:
Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.
Renal: Creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73 m2 or a serum creatinine based on age/gender.
Cardiac: Shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA), choice of test according to local standard of care.
Hepatic: SGOT (AST) or SGPT (ALT) \< 5 x upper limit of normal (ULN) for age. Conjugated bilirubin \< 2.5 mg/dL, unless attributable to Gilbert's Syndrome.
Exclusion
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).
What this trial measures
- Two Year Event-free SurvivalTwo years
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.