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Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Leukemia

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion pushed from Jun 30, 2026 to Sep 30, 2026v12
  2. Primary completion moved earlier from Jun 15, 2026 to Feb 19, 2026v11
  3. Re-verified, no change to tracked fieldsv10
  4. Primary completion date: Jan 15, 2026 to Jun 15, 2026
    • Study completion date: Jan 31, 2026 to Jun 30, 2026
    v9
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 27 to confirmed 11
    • Site details revised at 2 of 2 sites
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Aug 15, 2024 to Jan 15, 2026
    • Study sites: 1 to 2
    • Study completion date: Dec 31, 2025 to Jan 31, 2026
    • Eligibility criteria expanded, about 46 words
    v7
  2. Primary completion date changed from estimate of Dec 31, 2024 to Aug 15, 2024v6
  3. Lead sponsor: John Reneau to Jonathan Brammer
    • Site contact updated
    v5
  4. Enrollment target: 21 to 27
    • Eligibility criteria shortened, about 7 words
    v4
  5. Lead sponsor: Jonathan Brammer to John Reneau
    • Start date changed from estimate of May 1, 2022 to Jun 29, 2022
    • Site contact updated
    v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Start date: Dec 1, 2021 to May 1, 2022
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Secondary endpoints revised (9)
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Jonathan Brammer
3 trials monitored
See 1 trial at risk
Leukemia
2,948 trials monitored
See 180 trials at risk
This phase I/II trial studies the best dose, possible benefits and/or side effects of oral azacitidine in treating patients with T-cell large granular lymphocytic leukemia that has come back (relapsed) or has not responded to previous treatment (refractory). Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Trial Details
NCT Number NCT05141682
Lead Sponsor Jonathan Brammer
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 T-Cell Large Granular Lymphocyte Leukemia
Related terms Leukemia, Large Granular Lymphocytic
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov