RecruitingB-cell Acute Lymphoblastic Leukemia

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

Eligible age

1–25 yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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About this study

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).

Sponsor: Pediatric Transplantation & Cellular Therapy Consortium

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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).