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

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929408
• Other study ID #: 2368.00
• Secondary ID: RSG-13-084-01-CP
• Status: Completed
• Start date: July 19, 2013
• Est. completion date: December 4, 2018

Study information

• Verified date: November 2019
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	The John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
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	Stanford Cancer Institute	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	American Cancer Society, Inc., Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)	Percentage analyzed participants receiving HCT	1 year after starting induction
Secondary	Percentage Analyzed Participants Without HCT and Deceased	Percentage analyzed participants without HCT and Deceased	1 year after starting induction