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Natural Killer Cells in Older Patients With Acute Myeloid Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cytarabine
laboratory biomarker analysis
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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)

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Outcomes

Primary Outcome Measures

Evolution of functional natural killer (NK) cells after chemotherapy

Secondary Outcome Measures

Kinetics of NK cells
Activation markers of NK cells

Full Information

First Posted
October 5, 2007
Last Updated
May 13, 2011
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT00540956
Brief Title
Natural Killer Cells in Older Patients With Acute Myeloid Leukemia
Official Title
Descriptive Study Evaluating the Presence and Function of Natural Killer Cells in Elderly Patients With Acute Myeloid Leukemia in First Remission.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Evolution of functional natural killer (NK) cells after chemotherapy
Secondary Outcome Measure Information:
Title
Kinetics of NK cells
Title
Activation markers of NK cells

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Vey, MD
Organizational Affiliation
Institut Paoli-Calmettes
Facility Information:
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France

12. IPD Sharing Statement

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Natural Killer Cells in Older Patients With Acute Myeloid Leukemia

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