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Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Site contacts updated at 1 of 6 sitesv9
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2027
    • Study completion date: Dec 31, 2026 to Dec 31, 2028
    v8
  3. Primary completion date: Dec 31, 2023 to Dec 31, 2025
    • Study sites: 2 to 6
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v7
  4. Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v6
  5. Study sites: 1 to 2v5
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  1. Interventions: Brentuximab Vedotin (Drug), Dexamethasone (Drug), Doxorubicin (Drug), Etoposide (Drug), Ifosfamide (Drug), Methotrexate (Drug)… to Brentuximab Vedotin (Drug), Dexamethasone (Drug), Doxorubicin (Drug), Etoposide (Drug), Ifosfamide (Drug), Methotrexate (Drug), Prednisone…v4
  2. Interventions: Methotrexate, ifosfamide, dexamethasone, etoposide, pegasparagase, (Drug), pralatraxate, cyclophosphamide, doxorubicin, prednisone… to Brentuximab Vedotin (Drug), Dexamethasone (Drug), Doxorubicin (Drug), Etoposide (Drug), Ifosfamide (Drug), Methotrexate (Drug)…v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2018 to Mar 1, 2019
    • Study sites: 0 to 1
    • Study title shortened, about 19 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients are in 2 cohorts: Cohort 1: dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide (modified SMILE) chemotherapy regimen alone and pembrolizumab in children, adolescents, and young adults with advanced stage NK lymphoma and leukemia Cohort 2: combining pralatrexate (PRX) (Cycles 1, 2, 4, 6) and brentuximab vedotin (BV) (Cycles 3, 5) to cyclophosphamide, doxorubicin, and prednisone in children, adolescent, and young adults with advanced peripheral T-cell lymphoma (non-anaplastic large cell lymphoma or non-NK lymphoma/leukemia) . Both groups proceed to allogeneic stem cell transplant with disease response.
Trial Details
NCT Number NCT03719105
Lead Sponsor New York Medical College
Collaborators: University of Alabama at Birmingham
Conditions
(from sponsor)		 NK-Cell Lymphoma, NK-Cell Leukemia, Peripheral T Cell Lymphoma
Related terms Leukemia, Large Granular Lymphocytic, Lymphoma, T-Cell, Peripheral
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov