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A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv21
  2. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Jul 31, 2025 to Jul 2029
    • Study completion date: Aug 2027 to Jul 2030
    • Site details revised at 8 of 8 sites
    v20
  3. Re-verified, no change to tracked fieldsv19
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 8 of 8 sites
    v18
  5. Study sites: 7 to 8v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 6 to 7v16
  2. Primary completion date: Aug 2022 to Jul 31, 2025
    • Study completion date: Aug 2024 to Aug 2027
    v15
  3. Study description expanded, about 9 wordsv14
  4. Study sites: 5 to 6v13
  5. Study sites: 4 to 5v12
  6. Study sites: 3 to 4v11
  7. Study sites: 2 to 3v10
  8. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v9
  9. Start date: Nov 30, 2019 to May 24, 2021v8
  10. Study sites: 1 to 2v7
  11. Re-verified, no change to tracked fieldsv6
  12. Trial status: Suspended to Active, Not Recruitingv5 Show 5 more changesShow less
    • Primary completion date: Jun 30, 2021 to Aug 2022
    • Study completion date: Jun 30, 2023 to Aug 2024
    • Start date: Dec 5, 2019 to Nov 30, 2019
    • Eligibility criteria expanded, about 12 words
    • Study description shortened, about 29 words
  13. Trial status: Recruiting to Suspended Sponsor's reason: Study contract changes
    • Study site revised
    • Collaborators: 3 to 6
    v4
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 30, 2019 to Dec 5, 2019
    v3
  15. Collaborators: 1 to 3v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 feasibility trial studies how well daratumumab in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-EPOCH) works in treating patients with newly diagnosed stage I-IV plasmablastic lymphoma. Plasmablastic lymphoma cells have high levels of a protein called CD38. Daratumumab is a monoclonal antibody that specifically targets CD38 expressing cells, and may help the body's immune system attack the cancer and interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab may enhance the effectiveness of a standard chemotherapy (DA-EPOCH) in patients with plasmablastic lymphoma.
Trial Details
NCT Number NCT04139304
Lead Sponsor AIDS Malignancy Consortium
Collaborators: National Cancer Institute (NCI), Janssen Scientific Affairs, LLC, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center, AIDS and Cancer Specimen Resource, The Emmes Company, LLC
Conditions
(from sponsor)		 Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma, Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
Related terms Plasmablastic Lymphoma
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov