NCT01929408

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 703 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia (AML)
• Myelodysplastic Syndrome (MDS)

Timeline

• Start date: 2013-07-19
• Primary completion: 2018-12-04
• Completion: 2018-12-04
• First posted: 2013-08-28
• Last updated: 2019-11-15
• Results posted: 2019-11-15

Locations

12 sites across 1 country: United States