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 imm

Trial Details

NCT ID
NCT04972942
Phase
PHASE1
Sponsor
New York Medical College
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Daratumumab
Locations (sample)
  • Phoeniz, Arizona, United States
  • Loma Linda, California, United States|34.04835,-117.26115
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Francisco, California, United States|37.77493,-122.41942
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy (including seco…
  • Planned allogeneic stem cell transplantation with donor identified
  • Performance status ≥ 60%
  • Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

For full eligibility, visit ClinicalTrials.gov.

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