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Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion moved earlier from Sep 11, 2026 to Oct 24, 2023
    • Results first posted: Aug 18, 2026
    v20
  2. Enrollment target: estimated 30 to confirmed 29v19 Show 5 more changesShow less
    • Primary completion date changed from estimate of Sep 11, 2026 to Oct 24, 2023
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints revised (8)
    • Primary endpoint revised
    • Study site revised
  3. Re-verified, no change to tracked fieldsv18
  4. Primary completion date: Sep 11, 2025 to Sep 11, 2026
    • Study completion date: Feb 20, 2031 to Feb 20, 2032
    v17
  5. Primary completion date: Dec 31, 2024 to Sep 11, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary completion date: Feb 20, 2024 to Dec 31, 2024v15
  2. Primary completion date: Dec 2023 to Feb 20, 2024
    • Study completion date: Dec 2023 to Feb 20, 2031
    v14
  3. Primary endpoint revisedv13 Show 4 more changesShow less
    • Interventions: Ibrutinib (Drug), Obinutuzumab (Drug) to Ibrutinib (Drug), Laboratory Biomarker Analysis (Other), Obinutuzumab (Biological)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 4 to 8
    • Study description expanded, about 114 words
  4. 2 versions Re-verified since Apr 17, 2023, no change to tracked fieldsv11-v12
  5. Primary completion date: Dec 2022 to Dec 2023v10
  6. Primary completion date: Nov 2021 to Dec 2022
    • Study completion date: Jan 2022 to Dec 2023
    v9
  7. Secondary endpoints expanded, about 22 wordsv8
  8. Re-verified, no change to tracked fieldsv7
  9. Site contact updatedv6
  10. Eligibility criteria shortened, about 25 wordsv5
  11. Eligibility criteria expanded, about 49 wordsv4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2018 to Feb 20, 2018
    v3
  13. Start date: Nov 2017 to Dec 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's lymphomas.
Trial Details
NCT Number NCT03198026
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Collaborators: Genentech, Inc., Pharmacyclics LLC.
Conditions
(from sponsor)		 Non-Hodgkin's Lymphoma, Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Ann Arbor Stage II Follicular Lymphoma, Ann Arbor Stage II Nodal Marginal Zone Lymphoma, Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma, Ann Arbor Stage III Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Ann Arbor Stage III Follicular Lymphoma, Ann Arbor Stage III Nodal Marginal Zone Lymphoma +11 more
Related terms Lymphoma, Follicular, Lymphoma, Non-Hodgkin
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov