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

NCT01929408 | Completed Results

• 2 other identifiers: 2368.00RSG-13-084-01-CPHPS
• Study Type: observational
• Target: 703
• Locations: 1 country
• Sites: 12

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)

  Percentage analyzed participants receiving HCT

  1 year after starting induction

Secondary Outcomes (1)

• Percentage Analyzed Participants Without HCT and Deceased

  1 year after starting induction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• American Cancer Society, Inc.: collaborator

Study Sites (12)

Stanford Cancer Institute

Stanford, California, 94305, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

SCCA Network Clinics

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• Sorror ML, Gooley TA, Storer BE, Gerds AT, Sekeres MA, Medeiros BC, Wang ES, Shami PJ, Adekola K, Luger S, Baer MR, Rizzieri DA, Wildes TM, Koprivnikar J, Smith J, Garrison M, Kojouri K, Schuler TA, Leisenring WM, Onstad LE, Becker PS, McCune JS, Lee SJ, Sandmaier BM, Appelbaum FR, Estey EH. An 8-year pragmatic observation evaluation of the benefits of allogeneic HCT in older and medically infirm patients with AML. Blood. 2023 Jan 19;141(3):295-308. doi: 10.1182/blood.2022016916.

  PMID: 36260765 DERIVED

• 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.

  PMID: 34351368 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Results Point of Contact

• Title: Mohamed Sorror, MD, MSc
• Organization: Fred Hutchinson Cancer Research Center

msorror@fredhutch.org

(206) 667-6298

Study Officials

• Mohamed Sorror, MD, MSc

  Associate Member, Fred Hutch; Associate Professor of Medicine, UW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 28, 2013
• Study Start: July 19, 2013
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: November 15, 2019
• Results First Posted: November 15, 2019

Record last verified: 2019-11

Locations

US (12)