Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma

A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Pre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.

NCT Number	NCT04972942
Lead Sponsor	New York Medical College
Conditions	T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma
Enrollment	30 participants
Start Date	2023-05-22
Primary Completion	2027-09 (estimated)
Study Completion	2028-09 (estimated)
Updated on ClinicalTrials.gov	2026-04-15