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

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).

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 703

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • The John Theurer Cancer Center at Hackensack University Medical Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Abramson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Huntsman Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center
    • Seattle, Washington, United States, 98109
      • SCCA Network Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)	Percentage analyzed participants receiving HCT	1 year after starting induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Analyzed Participants Without HCT and Deceased	Percentage analyzed participants without HCT and Deceased	1 year after starting induction

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: Patient-Centered Outcomes Research Institute; American Cancer Society, Inc.
• Investigators: Principal Investigator: Mohamed Sorror, MD, MSc, Associate Member, Fred Hutch; Associate Professor of Medicine, UW

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2013
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): December 4, 2018

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (Estimate): August 28, 2013

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Myelodysplastic Syndromes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia
• Other Study ID Numbers: 2368.00; RSG-13-084-01-CPHPS (Other Grant/Funding Number: American Cancer Society)