Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Detailed Description
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This is a prospective multicenter observational study in a Consortium of collaborating institutions investigating how often older and medically infirm patients who are diagnosed with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndromes (MDS) and treated with induction chemotherapy undergo allogeneic HCT. Investigators will look at the rate of undergoing allogeneic HCT among older and medically infirm AML and high-risk MDS patients compared to younger and relatively healthier patients. Investigators will also compare the characteristics and outcomes of patients who did versus did not proceed to allogeneic HCT. A number of outcomes will be assessed including mortality, morbidity, and quality of life (QOL). Baseline information will be collected on different domains of QOL, geriatric assessment, health status measures, AML features, and socioeconomic status. Information will help physicians and patients to decide on best treatment choices for AML and high-risk MDS in older and medically infirm patients.

Official Title
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Feasibility and Outcomes of Allogeneic Hematopoietic Cell Transplantation (HCT) Compared to Conventional Therapy for Older and Medically Infirm Patients Diagnosed With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes: A Prospective Observational Study

Conditions
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Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients with new diagnoses of non-M3 AML or high-risk MDS, myeloproliferative neoplasms (MPN), or myelofibrosis (MF) (showing 10% or more blasts in bone marrow) who: Present for an AML-like treatment that could plausibly produce a complete remission (CR); for example intensive induction chemotherapy, low dose single agent chemotherapy, hypomethylation agent, or a similar therapy Possibility to retrieve follow-up records from the collaborating institution or treating primary care physician Patients with primary refractory or first relapse presenting for salvage chemotherapy will be allowed Patients of 18 years of age or older, and are being treated by the adult AML service. Able to speak and read English. Willing and able to provide informed consent. Exclusion Criteria Patients of ≤17 years of age or who are 18 or older and receive treatment under the pediatric AML service. Patients older than 80 years Patients with <6 months projected survival due to active second malignancy or other medical problem.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT) | Percentage analyzed participants receiving HCT | 1 year after starting induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Analyzed Participants Without HCT and Deceased | Percentage analyzed participants without HCT and Deceased | 1 year after starting induction |