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A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 81 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv81
  2. Study completion date: Oct 23, 2028 to Oct 23, 2034v80
  3. Study completion date: Oct 23, 2023 to Oct 23, 2028v79
  4. Study completion date: Feb 4, 2022 to Oct 23, 2023v78
  5. Study completion date: Feb 4, 2023 to Feb 4, 2022v77
Show 45 earlier versionsHide 45 earlier versions
  1. Results first posted: Oct 8, 2020v76 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Study completion date: Feb 4, 2022 to Feb 4, 2023
    • Eligibility criteria shortened, about 82 words
    • Study site revised
    • Study title shortened, about 8 words
    • Study description expanded, about 1 word
  2. 5 versions Re-verified since Apr 24, 2020, no change to tracked fieldsv71-v75
  3. Primary endpoint revised
    • Enrollment target: 28 to 29
    • Primary completion date changed from estimate of Feb 4, 2021 to Oct 2, 2019
    • Study completion date: Jul 1, 2021 to Feb 4, 2022
    v70
  4. 8 versions Re-verified since Oct 25, 2019, no change to tracked fieldsv62-v69
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 32 to confirmed 28
    • Site details revised
    v61
  6. 9 versions Re-verified since May 22, 2019, no change to tracked fieldsv52-v60
  7. Eligibility criteria revisedv51
  8. Re-verified, no change to tracked fieldsv50
  9. Primary completion date: Feb 4, 2020 to Feb 4, 2021
    • Start date: Jul 31, 2015 to Dec 9, 2015
    • Study completion date: Jul 1, 2020 to Jul 1, 2021
    v49
  10. 8 versions Re-verified since Aug 4, 2018, no change to tracked fieldsv41-v48
  11. Study description revised
    • Study arms: 0 to 1
    v40
  12. 5 versions Re-verified since May 22, 2018, no change to tracked fieldsv35-v39
  13. Site contact updatedv34
  14. 2 versions Re-verified since Mar 17, 2018, no change to tracked fieldsv32-v33
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pilot phase 2 study investigating the safety and efficacy of ibrutinib combined with short-course fludarabine in previously untreated CLL patients. Ibrutinib will be given daily until disease progression or intolerable side effects occur. Fludarabine will be given in cycles 3 and 4. The primary efficacy endpoint is the rate of complete response after 6 cycles or 24 weeks. The primary safety endpoint is the rate of treatment discontinuation after 6 cycles or 24 weeks.
Trial Details
NCT Number NCT02514083
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Related terms Leukemia, Lymphocytic, Chronic, B-Cell
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov