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



Status:Completed
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 80
Updated:1/2/2019
Start Date:July 19, 2013
End Date:December 4, 2018

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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

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

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.

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.
We found this trial at
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sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Eunice Wang, MD
Phone: 716-845-4971
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Aaron Gerds, MD
Phone: 216-636-5646
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: David Rizzieri, MD
Phone: 919-668-1016
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Mohamed Sorror, MD, MSc
Phone: 206-667-7263
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Maria Baer, MD
Phone: 410-328-2577
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Kehinde Adekola, MD
Phone: 312-695-8700
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Principal Investigator: Jamie Koprivnikar, MD
Phone: 551-996-8017
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Philadelphia, Pennsylvania 19104
Principal Investigator: Selina Luger, MD
Phone: 215-614-1812
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Tanya Wildes, MD, MSCI
Phone: 314-747-4678
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84112
Principal Investigator: Paul Shami, MD
Phone: 801-581-4467
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Seattle, Washington 98109
Phone: 206-288-7232
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Stanford, California 94305
Principal Investigator: Bruno Medeiros, MD
Phone: 650-723-2781
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