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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929408
Recruitment Status : Completed
First Posted : August 28, 2013
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
American Cancer Society, Inc.
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research 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).

Condition or disease
Acute Myeloid Leukemia (AML) 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.

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Study Type : Observational
Actual Enrollment : 703 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 19, 2013
Actual Primary Completion Date : December 4, 2018
Actual Study Completion Date : December 4, 2018





Primary Outcome Measures :
  1. Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT) [ Time Frame: 1 year after starting induction ]
    Percentage analyzed participants receiving HCT


Secondary Outcome Measures :
  1. Percentage Analyzed Participants Without HCT and Deceased [ Time Frame: 1 year after starting induction ]
    Percentage analyzed participants without HCT and Deceased



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include non-M3 AML (including first relapsed and primary refractory AML) and high-risk MDS, MPN, and MF adult patients considered for chemotherapy at FHCRC and the Seattle Cancer Care Alliance Network and other Core institutions (Stanford School of Medicine, Cleveland Clinic, Northwestern University, University of Utah, University of Pennsylvania, Washington University in St. Louis, Roswell Park Cancer Institute, Hackensack University, University of Maryland, and Duke University).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929408


Locations
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United States, California
Stanford Cancer Institute
Stanford, California, United States, 94305
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
The John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
SCCA Network Clinics
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Patient-Centered Outcomes Research Institute
American Cancer Society, Inc.
Investigators
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Principal Investigator: Mohamed Sorror, MD, MSc Associate Member, Fred Hutch; Associate Professor of Medicine, UW
  Study Documents (Full-Text)

Documents provided by Fred Hutchinson Cancer Research Center:
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01929408    
Other Study ID Numbers: 2368.00
RSG-13-084-01-CPHPS ( Other Grant/Funding Number: American Cancer Society )
First Posted: August 28, 2013    Key Record Dates
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions