ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 30, 2026 → Oct 30, 2028
Enrollment reduced 44% 70 → 39 participants
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 30, 2026 to Oct 30, 2028
  2. Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 5 of 5 entries
  3. Enrollment reduced: 70 → 39 participants
    • Enrollment closed, study ongoing
    • Site details revised
    v16
  4. 4 versions Re-verified since Feb 28, 2025, no change to tracked fieldsv12-v15
  5. Primary and study completion dates: Oct 30, 2024 to Oct 30, 2026v11
Show 9 earlier versionsHide 9 earlier versions
  1. Re-verified, no change to tracked fieldsv10
  2. Eligibility criteria expanded, about 34 wordsv9
  3. 2 versions Re-verified since Oct 2, 2023, no change to tracked fieldsv7-v8
  4. Primary and study completion dates: Oct 30, 2023 to Oct 30, 2024v6
  5. Primary and study completion dates: Oct 30, 2022 to Oct 30, 2023v5
  6. Re-verified, no change to tracked fieldsv4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 30, 2021 to Oct 21, 2021
    • Site details revised
    v3
  8. Start date: Oct 30, 2021 to Dec 30, 2021v2
  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 effect of ASTX727 and dasatinib in treating patients with newly diagnosed Philadelphia chromosome or BCR-ABL positive chronic myeloid leukemia in chronic phase. Philadelphia chromosome positive and BCR-ABL positive are types of genetic mutations (changes). Chemotherapy drugs, such as ASTX727, 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. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 and dasatinib may help to control Philadelphia chromosome-positive chronic myeloid leukemia or BCR-ABL positive chronic myeloid leukemia in chronic phase.
Trial Details
NCT Number NCT05007873
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI), Astex Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Chronic Phase Chronic Myelogenous Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Related terms Leukemia, Myeloid, Chronic-Phase
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov