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Clinical Trials/NCT01929408
NCT01929408CompletedNot Applicable

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

Fred Hutchinson Cancer Center12 sites in 1 country703 target enrollmentStarted: July 19, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
703
Locations
12
Primary Endpoint
Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)

Time Frame: 1 year after starting induction

Percentage analyzed participants receiving HCT

Secondary Outcomes

  • Percentage Analyzed Participants Without HCT and Deceased(1 year after starting induction)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (12)

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