The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL

Description

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

B-cell Acute Lymphoblastic Leukemia

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Study Overview

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Study Details

Study overview

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).

A Phase II Pilot Trial to Estimate Survival After a Non-total Body Irradiation (TBI) Based Conditioning Regimen in Patients Diagnosed With B-acute Lymphoblastic Leukemia (ALL) Who Are Pre-allogeneic Hematopoietic Cell Transplantation (HCT) Next-generation-sequence (NGS) Minimal Residual Disease (MRD) Negative

The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL

Condition
B-cell Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's of Alabama/University of Alabama in Birmingham(UAB), Birmingham, Alabama, United States, 35233

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Duarte

City of Hope, Duarte, California, United States, 91010

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Los Angeles

UCLA Mattel Children's Hospital, Los Angeles, California, United States, 90095

Oakland

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States, 94609

San Francisco

UCSF, San Francisco, California, United States, 94123

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

New Haven

Yale University School of Medicine, New Haven, Connecticut, United States, 06520

Wilmington

Alfred I. duPont Hospital for Children - Nemours Deleware, Wilmington, Delaware, United States, 19803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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).

Ages Eligible for Study

1 Year to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Los Angeles,

Hisham Abdel-Azim, MD, STUDY_CHAIR, Children's Hospital Los Angeles

Troy Quigg, DO, STUDY_CHAIR, Methodist Hospital - Texas Transplant Institute

Study Record Dates

2026-07-01