Impact of Treatment Intensity on Survival, Quality of Life, and Resource Utilization in Medically Less Fit Adults With Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms: A Randomized Pilot Study
Fred Hutchinson Cancer Center
Summary
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.
Description
OUTLINE: This pilot umbrella trial will explore the feasibility of randomizing patients to higher or lower intensity treatment regimens. The exact treatment regimens given will be at the discretion of the treating physician and will be provided either as standard of care or following enrollment on a subsequent treatment trial. Patients and physicians indicate willingness to randomize, those willing are randomized to 1 of 2 arms, those unwilling choose arm III or IV. ARM I: Patients receive standard of care (SOC) or investigational higher-intensity therapy on a subsequent treatment trial th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of high grade myeloid neoplasm (\> 10% blasts in blood or marrow), other than acute promyelocytic leukemia (APL) according to the 2022 International Consensus Classification (ICC) classification. Patients with acute leukemias of ambiguous lineage are eligible * The use of cytoreductive therapy before treatment is permitted. Patients with symptoms/signs of leukostasis, white blood cell (WBC) \> 100,000/μL, or acute symptoms that in the opinion of the treating physician are likely related to their high-grade myeloid neoplasm may receive up to 2 d…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Collection
Undergo bone marrow assessment
- OtherElectronic Health Record Review
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington