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Completed

NCT Number: NCT00540956

Natural Killer Cells in Older Patients With Acute Myeloid Leukemia

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.

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Key information

Conditions

Leukemia Bone Marrow Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Erythroblastic, Acute Leukemia, Megakaryoblastic, Acute Leukemia, Monocytic, Acute Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Marseille, 13273, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytarabine

Drug

laboratory biomarker analysis

Other

Primary outcomes

  1. Evolution of functional natural killer (NK) cells after chemotherapy

Secondary outcomes

  1. Kinetics of NK cells

  2. Activation markers of NK cells

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
First posted
Oct 8, 2007
Registry last updated
May 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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