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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-01

Study Completion Date

2014-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chemotherapy, Low-intensity therapy, elderly, prognosis,

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LAM group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Eligible Sex

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CORTIAL

Pierre-Bénite, Rhone, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HCL

Identifier Type: -

Identifier Source: org_study_id