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

Completed

• Conditions: Myelodysplastic Syndrome (MDS); Acute Myeloid Leukemia (AML)

• Registration Number: NCT01929408
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2013-07-19
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-28
• Primary Completion: 2018-12-04
• Study Completion: 2018-12-04
• Results First Submitted: 2019-04-26
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Results First Posted: 2019-11-15
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 703

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)	1 year after starting induction	Percentage analyzed participants receiving HCT

Secondary Outcome Measures

Name	Time	Method
Percentage Analyzed Participants Without HCT and Deceased	1 year after starting induction	Percentage analyzed participants without HCT and Deceased

Trial Locations

Locations (12)

Stanford Cancer Institute; 🇺🇸 Stanford, California, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

The John Theurer Cancer Center at Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

University of Utah Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

SCCA Network Clinics; 🇺🇸 Seattle, Washington, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States