Clinical trial NCT01929408: Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS)
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: American Cancer Society, Inc.
First posted: 2013-08-28
Enrollment: 703
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

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.

Eligibility 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.

Primary outcomes:
measure: Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)
timeFrame: 1 year after starting induction
Secondary outcomes:
measure: Percentage Analyzed Participants Without HCT and Deceased
timeFrame: 1 year after starting induction
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: The John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: SCCA Network Clinics
state: Washington
Study officials:
affiliation: Associate Member, Fred Hutch; Associate Professor of Medicine, UW
name: Mohamed Sorror, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorror ML, Storer BE, Fathi AT, Brunner A, Gerds AT, Sekeres MA, Mukherjee S, Medeiros BC, Wang ES, Vachhani P, Shami PJ, Pena E, Elsawy M, Adekola K, Luger S, Baer MR, Rizzieri D, Wildes TM, Koprivnikar J, Smith J, Garrison M, Kojouri K, Leisenring W, Onstad L, Nyland JE, Becker PS, McCune JS, Lee SJ, Sandmaier BM, Appelbaum FR, Estey EH. Multisite 11-year experience of less-intensive vs intensive therapies in acute myeloid leukemia. Blood. 2021 Aug 5;138(5):387-400. doi: 10.1182/blood.2020008812.