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Tazemetostat and Palbociclib With CPX-351for R/R AML

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Study description expanded, about 25 wordsv15
  2. Re-verified, no change to tracked fieldsv14
  3. Trial status: Suspended to Recruiting
    • Primary completion date: Jan 2026 to Jan 2028
    • Study completion date: Jan 2026 to Jan 2029
    • Site details revised
    v13
  4. Study description shortened, about 35 words
    • Study title shortened, about 10 words
    • Collaborators expanded, about 4 words
    v12
  5. Trial status: Recruiting to Suspended Sponsor's reason: Cohort Closed
    • Site details revised
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Re-verified, no change to tracked fieldsv10
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2023 to Aug 28, 2023
    • Site details revised
    v9
  3. Enrollment target: 15 to 24
    • Study description expanded, about 135 words
    • Study title revised
    • Study arms: 1 to 2
    v8
  4. Start date: Jul 2023 to Aug 2023
    • Study description shortened, about 41 words
    v7
  5. Start date: May 2023 to Jul 2023v6
  6. Start date: Mar 2023 to May 2023v5
  7. Start date: Feb 2023 to Mar 2023v4
  8. Start date: Dec 2022 to Feb 2023v3
  9. Start date: Nov 2022 to Dec 2022v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 two-part phase Ib dose escalation study to evaluate the safety and preliminary efficacy of the combination of tazemetostat and CPX-351 (Part 1) and of pre-treatment with palbociclib followed by CPX-351 (Part 2) for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). Part 1 of the study will seek to establish the safety, tolerability, biological activity and recommended dose for further evaluation (RDFE) of tazemetostat in combination with standard-dose CPX-351. Part 2 of the study will seek to establish the safety, tolerability, biological activity RDFE of pre-treatment palbociclib prior CPX-351.
Trial Details
NCT Number NCT05627232
Lead Sponsor Thomas Jefferson University
Collaborators: Pennsylvania Department of Health
Conditions
(from sponsor)		 Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov