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OpenTrials
Completed

NCT Number: NCT03350152

Treatment With Low-Dose Cytarabine in Elderly Patients (Age 70 Years or Older) With Acute Myeloid Leukemia: A Single Institution Experience.

The treatment of very elderly patients (≥70 years) with acute myeloid leukemia remains controversial. Although the outcome in younger adults has improved because of cytarabine- and anthracycline-based chemotherapy with advanced supportive care and introduction of hematopoietic stem cell transplantation, the benefit associated with standard intensive chemotherapy in older patients remain debatable. Life expectancy in elderly patients is a function of age, disability and comorbidity, performance score, along with leukemia characteristics such as genetic alterations or white blood cell count at diagnosis 'Older' patients are generally considered those aged 60 years or older.

Intensive chemotherapy delivered to the very elderly with AML (patients _70 years of age), may not be beneficial to most and could be harmful to some. However, these patients are often referred to as 'unfit' or ineligible for intensive remission induction therapy. In daily practice, the final decision to treat intensively or not is made by the treating hematologist on a case by case basis according to patient's age, cytogenetics, performance score, concomitant diseases and type of AML (de novo or secondary).

In older patients considered 'unfit' for intensive treatment, LD-AraC has been demonstrated to be more beneficial than best supportive care and hydroxyurea. The recent availability of new drugs that may have an improved side effect profile and in some cases bioavailability may offer future improvement for this patient population. The efficacy of hypomethylating agents has been studied in older AML patients with conflicting results. Recent publications refined prognostic information, which not only optimize existing treatments but also could lead to the development of additional targeted therapeutic approaches.

In this study, the investigators focus on patients with AML (_20% blasts) aged 70 or older seen in our institution over a 14-year period. The objectives of the analysis are to describe the demographic, clinical and biological characteristics of this population and to evaluate how these characteristics and the treatment chosen affect

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Key information

Study type

Observational

Primary location

CORTIAL

Pierre-Bénite, Rhone, 69310, France

Who can participate

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

Inclusion criteria

  • Have a diagnosis of AML according to World Health Organization (WHO) classification
  • Are at least 70 years of age

Exclusion criteria

  • Patients with M3 AML of FAB classification (APL, Acute Promyelocytic Leukemia)

Treatment and study plan

Primary outcomes

  1. overall survival (OS)

    Time frame: Date of last contact if alive, up to 100 months

    OS was the main endpoint for this analysis. The event for OS was death, and patients were censored at the date of last contact, if alive.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2000
Primary completion
2014
Study completion
2014
First posted
Nov 22, 2017
Registry last updated
Nov 22, 2017

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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