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Natural Killer Cells in Older Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540956
First Posted: October 8, 2007
Last Update Posted: May 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Leukemia Drug: cytarabine Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Descriptive Study Evaluating the Presence and Function of Natural Killer Cells in Elderly Patients With Acute Myeloid Leukemia in First Remission.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Evolution of functional natural killer (NK) cells after chemotherapy

Secondary Outcome Measures:
  • Kinetics of NK cells
  • Activation markers of NK cells

Estimated Enrollment: 40
Study Start Date: November 2006
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540956


Locations
France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
OverallOfficial: Norbert Vey, MD Institut Paoli-Calmettes
  More Information

ClinicalTrials.gov Identifier: NCT00540956     History of Changes
Other Study ID Numbers: CDR0000564106
IPC-LAM-NK
INCA-RECF0429
IPC-2006/002
First Submitted: October 5, 2007
First Posted: October 8, 2007
Last Update Posted: May 16, 2011
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs