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Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v12
  2. Primary completion date: Dec 2024 to Dec 2026v11
  3. Study sites: 1 to 2
    • Collaborators expanded, about 5 words
    v10
  4. Re-verified, no change to tracked fieldsv9
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2022 to Feb 11, 2022
    • Site details revised
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Dec 2021 to Feb 2022v7
  2. Start date: Oct 2021 to Dec 2021v6
  3. Start date: Mar 2021 to Oct 2021v5
  4. Start date: Dec 2020 to Mar 2021v4
  5. Re-verified, no change to tracked fieldsv3
  6. Start date: Jun 2020 to Dec 2020
    • Primary completion date: Jun 2024 to Dec 2024
    • Study completion date: Jun 2026 to Dec 2026
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Aim of the trial is to evaluate the activity and tolerability of the anti PD1 agent Pembrolizumab in combination with RadioTherapy for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma who are not eligible to chemotherapy. It is planned to enroll 30 patients in chinese sites. All eligible patients will be treated with standard radiotherapy and concurrent pembrolizumab administered intravenously every 3 weeks. After 6 cycles of pembrolizumab patients with complete remission, partial response and stable disease will continue with pembrolizumab maintenance up to 2 years. Patients will be followed up to 4 years from treatment start.
Trial Details
NCT Number NCT04417166
Lead Sponsor International Extranodal Lymphoma Study Group (IELSG)
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Lymphoma, Extranodal NK-T-Cell
Related terms Lymphoma, Extranodal NK-T-Cell
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov