Pilot Study Immunomonitoring Natural Killers Cells in Patients With Myeloid Malignancies Treated With Lenalidomide
NCT ID: NCT02525250
Last Updated: 2015-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2012-12-31
2015-01-31
Brief Summary
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the role of NK cells was demonstrated in AML and especially GVL effect (graft versus leukemia) during allogeneic transplantation in these patients. However, it has been shown that the phenotype of NK cells and their cytotoxic functions were altered during this malignancy. In addition, in these patients, impaired NK function is associated with relapse.
lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a role in leukemic cells in this malignancy? what is its effect on the production of pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of NK cells from healthy donors and patients with LAM, and despite these phenotypic changes, the cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase in the production of TNF-alpha (tumor necrosis factor) by NK.
It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this study confirm these results in vivo in peripheral blood cells in patients treated with lenalidomide.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Acute myeloïd leukemia
Realization of 3 blood samples at day 0, day 15 and day 28.
Realization of 3 Blood samples during study during treatment with lenalidomide
Interventions
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Realization of 3 Blood samples during study during treatment with lenalidomide
Eligibility Criteria
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Inclusion Criteria
* Patient with myeloid acute leukemia or with myelodysplasic syndrome, treated or should be treated with Revlimid,
* Signed consent to participate,
* Patient affiliated to a social security system or benefiting from such as a system.
Exclusion Criteria
* Patient deprived of liberty or under supervision of a guardian,
* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
18 Years
ALL
No
Sponsors
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Institut Paoli-Calmettes
OTHER
Responsible Party
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Principal Investigators
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Thomas PREBET, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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Thomas PREBET, MD
Marseille, , France
Countries
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Related Links
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official web site of the sponsor
Other Identifiers
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MDS-AML-NK / IPC-2012-007
Identifier Type: -
Identifier Source: org_study_id
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