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
Objective
Primary Objective: Estimate 2-year event free survival (EFS) in pre-HCT NGS-MRD negative patients with B-ALL undergoing a non-TBI based conditioning regimen through a multi-center prospective trial.
Exploratory Objectives: Estimate overall survival (OS) following a non-TBI based conditioning regimen in B-ALL patients who are pre-HCT NGS-MRD negative. Correlate the presence of and level of pre-HCT NGS-MRD in BM samples of B-ALL patients screened for the trial with detectable disease with relapse, EFS, and OS after best available therapy offered by their transplant centers. Correlate the presence and level of NGS-MRD in BM samples of B-ALL patients pre- and post-HCT with overall and event-free survival (OS, EFS). Correlate pre- and post-HCT NGS-MRD levels in peripheral blood (PB) and BM samples of B-ALL patients pre- and post-HCT with relapse, OS, and EFS. Compare NGS-MRD in BM samples of B-ALL patients pre- and post-HCT with multichannel flow cytometry (MFC) for predictive ability for relapse, OS, and EFS. Assess the effect of acute and chronic GVHD on relapse, EFS, and OS in B-ALL patients with and without the presence of MRD measured by NGS or by MFC. Screen B-ALL clones at relapse post-HCT to assess whether changes in B-cell clonal rearrangements occur compared to pre-HCT blasts. Estimate rates of relapse, EFS, and OS in children < 3 undergoing a non-TBI based conditioning regimen for B-ALL and correlate these outcomes with flow and NGS-MRD measured pre- and post-HCT. Correlate the presence and level of NGS-MRD in BM samples of T-ALL and MPAL patients pre- and post-HCT with overall and event-free survival (OS, EFS).
