Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 39 days later Nov 10, 2025 → Dec 19, 2025
See other at-risk trials from Alliance Foundation Trials, LLC.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Study completion pushed from Aug 30, 2026 to Jul 30, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Publications: details revised at 8 of 8 entries
    • Study description expanded, about 2 words
  3. Primary completion pushed from Nov 10, 2025 to Dec 19, 2025v24
  4. Primary completion moved earlier from Mar 30, 2026 to Nov 10, 2025
    • Study completion pushed from Mar 30, 2026 to Aug 30, 2026
    v23
  5. 2 versions Re-verified since Dec 16, 2025, no change to tracked fieldsv21-v22
Show 19 earlier versionsHide 19 earlier versions
  1. Primary completion date: Jun 30, 2025 to Mar 30, 2026
    • Study completion date: Dec 2025 to Mar 30, 2026
    v20
  2. Primary completion date: Jun 1, 2024 to Jun 30, 2025
    • Study completion date: Dec 2024 to Dec 2025
    v19
  3. 2 versions Re-verified since Jan 5, 2024, no change to tracked fieldsv17-v18
  4. Primary completion date: Aug 1, 2023 to Jun 1, 2024
    • Study completion date: Dec 2023 to Dec 2024
    v16
  5. Trial status: Recruiting to Active, Not Recruitingv15 Show 4 more changesShow less
    • Enrollment target: estimated 61 to confirmed 39
    • Study sites: 11 to 9
    • Primary completion date: Jun 1, 2023 to Aug 1, 2023
    • Eligibility criteria expanded, about 34 words
  6. Re-verified, no change to tracked fieldsv14
  7. Primary completion date: Jun 2023 to Jun 1, 2023v13
  8. Primary completion date: Jun 2022 to Jun 2023
    • Study completion date: Dec 2022 to Dec 2023
    • Site details revised at 1 of 11 sites
    v12
  9. Study sites: 10 to 11v11
  10. Re-verified, no change to tracked fieldsv10
  11. Study sites: 8 to 10v9
  12. Site details revised at 8 of 8 sitesv8
  13. Study sites: 7 to 8v7
  14. Study sites: 5 to 7v6
  15. Re-verified, no change to tracked fieldsv5
  16. Study sites: 2 to 5
    • Publications: 5 to 8
    v4
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2018 to Sep 11, 2018
    v3
  18. Start date: Jun 2018 to Sep 2018v2 Show 4 more changesShow less
    • Primary completion date: Feb 2022 to Jun 2022
    • Study completion date: Aug 2022 to Dec 2022
    • Interventions: Ibrutinib Pill (Drug), Palbociclib (Drug) to Ibrutinib (Drug), Palbociclib (Drug)
    • Eligibility criteria shortened, about 1 word
  1. Study First Submitted
  • 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.
The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and the secondary objectives to include ORR, CR, DOR, OS and toxicity. Subjects will be enrolled and treated with palbociclib and ibrutinib with each cycle of therapy being 28 days. Treatment will be based on the recommended phase II dose (RP2D) from the phase I combination trial.
Trial Details
NCT Number NCT03478514
Lead Sponsor Alliance Foundation Trials, LLC.
Collaborators: Pfizer
Conditions
(from sponsor)		 Mantle Cell Lymphoma, B Cell Lymphoma
Related terms Lymphoma, B-Cell, Lymphoma, Mantle-Cell
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov