Randomization for the Identification of Best Treatment Intensity for Less Fit Adults With Acute Myeloid Leukemia and Myeloid Neoplasms

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Start date changed from estimate of Oct 15, 2026 to Oct 13, 2026
  2. Notable Start date: Sep 1, 2026 to Oct 15, 2026
    • Eligibility criteria expanded, about 19 words
    • Site details revised
  3. Notable Start date: Aug 1, 2026 to Sep 1, 2026v6
  4. Notable Start date: Jul 1, 2026 to Aug 1, 2026
    • Eligibility criteria expanded, about 34 words
    • Study description expanded, about 8 words
    v5
  5. Notable Recruitment opened
    • Start date: Jun 1, 2026 to Jul 1, 2026
    • Primary and study completion dates: Jun 1, 2029 to Jun 8, 2029
    • Site details revised
    v4
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  1. Notable Start date: Mar 1, 2026 to Jun 1, 2026v3
  2. Notable Start date: Dec 1, 2025 to Mar 1, 2026v2
  1. Minor 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 clinical trial studies whether less fit adults with acute myeloid leukemia (AML) or myeloid neoplasms are willing to let a computer program decide (randomization) whether they receive lower- or higher-intensity chemotherapy. Historically, treatment decision-making for patients with AML or myeloid neoplasms has divided patients into two categories, with patients considered fit receiving intensive "curative" chemotherapy, and patients considered unfit, such as older patients with a higher risk of early death from therapy, receiving non-intensive "palliative" therapy or no therapy. With the introduction of new treatment agents, it has become difficult to determine the difference between intensive and non-intensive therapy, especially for patients considered unfit for whom treatment-related side effects remain a concern. Treatment intensity is best identified through randomized trials but often patients are unwilling to undergo randomization due to preset beliefs. However, with improved supportive care and the awareness that new treatment agents may have similar risks as intensive therapy, it may be possible that more patients are willing to be randomized. This may help identify the best treatment intensity for less fit adults with AML or myeloid neoplasms, which may improve outcomes.
Trial Details
NCT Number NCT07094750
Lead Sponsor Fred Hutchinson Cancer Center
Conditions
(from sponsor)
Acute Leukemia of Ambiguous Lineage, Acute Myeloid Leukemia, Myeloid Neoplasm
Related terms Leukemia, Biphenotypic, Acute, Leukemia, Myeloid, Acute
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov