- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rhone
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Pierre-Bénite, Rhone, France, 69310
- CORTIAL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Have a diagnosis of AML according to World Health Organization (WHO) classification
- Are at least 70 years of age
- Gender male and female
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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LAM group
Have a diagnosis of AML according to World Health Organization (WHO) classification Are at least 70 years of age
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival (OS)
Time Frame: Date of last contact if alive, up to 100 months
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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.
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Date of last contact if alive, up to 100 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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