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Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Study completion pushed from Jul 2026 to Jan 2027 Show 4 more changesShow less
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description revised
    • Publications: details revised at 53 of 55 entries
    • Eligibility criteria expanded, about 4 words
  2. 2 versions Re-verified since Feb 17, 2026, no change to tracked fieldsv13-v14
  3. Study completion date: Oct 2025 to Jul 2026v12
  4. Study completion date: Dec 2024 to Oct 2025v11
  5. Study completion date: Jan 2024 to Dec 2024v10
Show 8 earlier versionsHide 8 earlier versions
  1. Results first posted: Jan 26, 2024v9 Show 4 more changesShow less
    • Primary endpoint revised
    • Primary completion date changed from estimate of Dec 2022 to Jan 3, 2017
    • Study completion date: Dec 2022 to Jan 2024
    • Secondary endpoints: 1 to 4
  2. 2 versions Re-verified since Apr 30, 2021, no change to tracked fieldsv7-v8
  3. Primary completion date: Feb 2020 to Dec 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 38 to confirmed 27
    • Site details revised
    v6
  4. Primary completion date: Dec 2019 to Feb 2020v5
  5. Primary completion date: Jun 2019 to Dec 2019
    • Study completion date: Jun 2022 to Dec 2022
    v4
  6. Primary completion date: Apr 2018 to Jun 2019
    • Study completion date: Jun 2020 to Jun 2022
    v3
  7. Primary completion date: May 2017 to Apr 2018
    • Study completion date: Nov 2017 to Jun 2020
    • Start date: May 2015 to Jun 18, 2015
    • Study title shortened, about 7 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a dose-escalation to determine the MTD and/or RPII for combinations of ibrutinib (PCI-32765) plus lenalidomide/rituximab in patients with relapsed/refractory mantle cell lymphoma.
Trial Details
NCT Number NCT02446236
Lead Sponsor Hackensack Meridian Health
Conditions
(from sponsor)		 Mantle Cell Lymphoma
Related terms Lymphoma, Mantle-Cell
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov