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NCT00540956 Clinical Trial

Natural Killer Cells in Older Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:
Descriptive Study Evaluating the Presence and Function of Natural Killer Cells in Elderly Patients With Acute Myeloid Leukemia in First Remission.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00540956
Other study ID # CDR0000564106
Secondary ID IPC-LAM-NKINCA-R
Status Completed
Phase N/A
First received October 5, 2007
Last updated May 13, 2011
Start date November 2006

Study information
Verified date July 2009
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Studying natural killer cells in samples of blood from patients with cancer may help doctors find out how these cells are effected by chemotherapy.

PURPOSE: This clinical trial is studying natural killer cells in older patients with acute myeloid leukemia.

Description:

OBJECTIVES:

Primary

- Determine the evolution of functional receptors of natural killer (NK) cells after completion of chemotherapy in elderly patients with acute myeloid leukemia in first remission.

Secondary

- Measure the kinetics of cytotoxic functional recovery of NK cells.

- Determine activation markers of NK cells.

OUTLINE: This is a multicenter study.

Patients receive 1 course of consolidation therapy comprising an anthracycline and cytarabine to induce first remission.

Blood is collected on day 0 of the consolidation course and then every 2 weeks for 8 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of acute myeloid leukemia

- No promyelocytic leukemia

- No prior therapy

PATIENT CHARACTERISTICS:

- Hemoglobin > 10 g/dL

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• cytarabine

Other:
• laboratory biomarker analysis

Locations
Country Name City State
France Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Marseille

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evolution of functional natural killer (NK) cells after chemotherapy No
Secondary Kinetics of NK cells No
Secondary Activation markers of NK cells No
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