NCT00540956

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 16, 2011

Status Verified

July 1, 2009

Enrollment Period

4.5 years

First QC Date

October 5, 2007

Last Update Submit

May 13, 2011

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemiaadult 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) abnormalitiesadult 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)

Outcome Measures

Primary Outcomes (1)

  • Evolution of functional natural killer (NK) cells after chemotherapy

Secondary Outcomes (2)

  • Kinetics of NK cells

  • Activation markers of NK cells

Interventions

cytarabineDRUG
laboratory biomarker analysisOTHER

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Marseille, 13273, France

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Erythroblastic, AcuteCongenital Abnormalities

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Norbert Vey, MD

    Institut Paoli-Calmettes

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 8, 2007

Study Start

November 1, 2006

Primary Completion

May 1, 2011

Last Updated

May 16, 2011

Record last verified: 2009-07

Locations

FR(1)