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

Study acronym: ALLO-T-DART
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site contacts updated at 1 of 16 sitesv6
  2. Site details revised at 2 of 16 sitesv5
  3. Study sites: 1 to 16
    • Eligibility criteria expanded, about 3 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2023 to May 22, 2023
    v3
  5. Phase: Phase 2 to Phase 1v2 Show 5 more changesShow less
    • Primary completion date: Sep 2025 to Sep 2027
    • Start date: Sep 2021 to May 2023
    • Enrollment target: 40 to 30
    • Study completion date: Sep 2026 to Sep 2028
    • Study description expanded, about 82 words
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04972942
Lead Sponsor New York Medical College
Conditions
(from sponsor)		 T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma
Related terms Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov