The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
Trial Parameters
Brief 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).
Eligibility Criteria
Inclusion Criteria for the Observational Arm: 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. * 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 no