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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350152
• Other study ID #: HCL
• Status: Completed
• Phase: N/A
• First received: November 8, 2017
• Last updated: November 20, 2017
• Start date: January 1, 2000
• Est. completion date: June 1, 2014

Study information

• Verified date: October 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: June 1, 2014
• Est. primary completion date: June 1, 2014
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
France	CORTIAL	Pierre-Bénite	Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)	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.	Date of last contact if alive, up to 100 months