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

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01929408

RSG-13-084-01-CPHPS (Other Grant/Funding Number)

2368.00

Details and patient eligibility

About

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

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.

Enrollment: 703 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design