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Completed

NCT Number: NCT01929408

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Cancer Institute, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)

    Time frame: 1 year after starting induction

    Percentage analyzed participants receiving HCT

Secondary outcomes

  1. Percentage Analyzed Participants Without HCT and Deceased

    Time frame: 1 year after starting induction

    Percentage analyzed participants without HCT and Deceased

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.
  • Patient-Centered Outcomes Research Institute

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2013
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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