Acute Myeloid Leukemia Clinical Trial

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

Summary

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

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Full Description

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.

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Eligibility Criteria

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.

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

703

Study ID:

NCT01929408

Recruitment Status:

Completed

Sponsor:

Fred Hutchinson Cancer Center

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There are 11 Locations for this study

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Stanford Cancer Institute
Stanford California, 94305, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
University of Maryland
Baltimore Maryland, 21201, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
The John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Duke University
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
University of Utah Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
SCCA Network Clinics
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

703

Study ID:

NCT01929408

Recruitment Status:

Completed

Sponsor:


Fred Hutchinson Cancer Center

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