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 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 tr

Trial Details

NCT ID
NCT03509961
Phase
PHASE2
Sponsor
Pediatric Transplantation & Cellular Therapy Consortium
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • NGS-MRD
  • Myeloablative allogeneic HCT with a non-TBI conditioning regimen
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Any patient with ALL who undergoes Myeloablative HCT including any of the following:
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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