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Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study completion date: Sep 13, 2024 to Sep 13, 2025v29
  2. Study completion date: May 13, 2024 to Sep 13, 2024v28
  3. 4 versions Re-verified since Mar 20, 2024, no change to tracked fieldsv24-v27
  4. Secondary endpoints: details revised at 3 of 5 entriesv23
  5. 4 versions Re-verified since Dec 16, 2020, no change to tracked fieldsv19-v22
Show 17 earlier versionsHide 17 earlier versions
  1. Results first posted: Sep 22, 2020v18 Show 4 more changesShow less
    • Primary endpoint revised
    • Interventions: Brentuximab Vedotin (Drug), Laboratory Biomarker Analysis (Other), Nivolumab (Biological) to Brentuximab Vedotin (Drug), Nivolumab (Biological)
    • Secondary endpoints revised (5)
    • Study description revised
  2. Enrollment target: estimated 75 to confirmed 46v17 Show 4 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study sites revised (9)
    • Study description expanded, about 1 word
  3. Primary completion date changed from estimate of Nov 13, 2019 to Aug 13, 2019v16
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 10 to 9
    v15
  5. Study sites: 9 to 10v14
  6. Primary endpoint revisedv13 Show 4 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints revised (5)
    • Site contacts updated at 3 of 9 sites
    • Study description expanded, about 4 words
  7. Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 7 of 9 sites
    • Study description shortened, about 4 words
    v12
  8. Site details revised at 1 of 9 sitesv11
  9. Study sites: 7 to 9v10 Show 6 more changesShow less
    • Primary completion date: Nov 2019 to Nov 13, 2019
    • Study completion date: May 2024 to May 13, 2024
    • Start date: May 2016 to May 13, 2016
    • Eligibility criteria expanded, about 74 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description expanded, about 4 words
  10. Study sites: 8 to 7
    • Primary completion date: Nov 13, 2019 to Nov 2019
    • Study completion date: May 13, 2024 to May 2024
    • Eligibility criteria expanded, about 4 words
    v9
  11. Site details revised at 1 of 8 sitesv8
  12. Primary completion date: Feb 2018 to Nov 13, 2019
    • Study completion date: May 13, 2024
    v7
  13. Site details revised at 1 of 8 sitesv6
  14. Site details revised at 1 of 8 sitesv5
  15. Site details revised at 1 of 8 sitesv4
  16. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 8 of 8 sites
    v3
  17. Start date: Apr 2016 to May 2016v2
  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.
This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older patients with untreated Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Biological therapies, such as brentuximab vedotin, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Nivolumab and brentuximab vedotin may work better in treating older patients with untreated Hodgkin lymphoma.
Trial Details
NCT Number NCT02758717
Lead Sponsor Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Ann Arbor Stage IB Hodgkin Lymphoma, Ann Arbor Stage II Hodgkin Lymphoma, Ann Arbor Stage IIA Hodgkin Lymphoma, Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage IIIA Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma +3 more
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov