Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 31, 2026 → Oct 31, 2028
See other at-risk trials from M.D. Anderson Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 31, 2026 to Oct 31, 2028
    • Eligibility criteria shortened, about 40 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 1 of 1 entry
  2. 6 versions Re-verified since Sep 4, 2025, no change to tracked fieldsv18-v23
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 85
    • Site details revised
    v17
  4. Site contact updatedv16
  5. Site contact updatedv15
Show 13 earlier versionsHide 13 earlier versions
  1. Enrollment target: 40 to 100
    • Primary and study completion dates: Oct 15, 2024 to Oct 31, 2026
    • Site contact updated
    v14
  2. 6 versions Re-verified since Sep 11, 2023, no change to tracked fieldsv8-v13
  3. Primary and study completion dates: Oct 15, 2023 to Oct 15, 2024v7
  4. Eligibility criteria shortened, about 3 words
    • Study description expanded, about 5 words
    v6
  5. Primary and study completion dates: Oct 15, 2022 to Oct 15, 2023v5
  6. Start date: Feb 21, 2021 to Feb 22, 2021v4
  7. Re-verified, no change to tracked fieldsv3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 31, 2021 to Feb 21, 2021
    • Site details revised
    v2
  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.
This phase II trial studies the possible benefits of venetoclax and ASTX727 in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory), or elderly patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive chemotherapy. Venetoclax may help block the formation of growths that may become cancer. ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Giving venetoclax and ASTX727 may help to control the disease.
Trial Details
NCT Number NCT04746235
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov