AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission

StatusTerminated
PhasePhase 2
Started

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Record History

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  1. Trial terminated Sponsor's reason: \<75% participation
    • Final enrollment: 36 participants (planned 50)
    • Primary completion date changed from estimate of Oct 31, 2030 to Oct 12, 2026
  2. Eligibility criteria shortened, about 7 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Publications: details revised at 1 of 1 entry
  3. 5 versions Re-verified since Jul 28, 2025, no change to tracked fieldsv19-v23
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v18
  5. 11 versions Re-verified since Oct 12, 2021, no change to tracked fieldsv7-v17
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  1. Study title shortened, about 2 wordsv6
  2. Eligibility criteria expanded, about 6 wordsv5
  3. 2 versions Re-verified since Feb 18, 2020, no change to tracked fieldsv3-v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 17, 2020 to Sep 13, 2019
    • Site details revised
    • Collaborators: 1 to 2
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II trial studies how well azacitidine and venetoclax work in treating patients with acute myeloid leukemia that is in remission. Drugs used in chemotherapy, such as azacitidine and venetoclax, 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 NCT04062266
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI), Genentech, Inc.
Conditions
(from sponsor)		 Acute Myeloid Leukemia in Remission, FLT3 Gene Mutation, Hematologic and Lymphocytic Disorder, Acute Myeloid Leukemia, Minimal Residual Disease Persistence, Therapy-Related Acute Myeloid Leukemia
Related terms Hematologic Diseases, Leukemia, Myeloid, Acute
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov