Pilot Study Immunomonitoring Natural Killers Cells in Patients With Myeloid Malignancies Treated With Lenalidomide
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|ClinicalTrials.gov Identifier: NCT02525250|
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : August 17, 2015
This project is a framework for developing new therapeutic strategies for acute myeloid leukemia(AML)based immunotherapy.
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia or Myelodysplasic Syndrome||Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Acute myeloïd leukemia
Realization of 3 blood samples at day 0, day 15 and day 28.
Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide
- Evaluation of NK functions [ Time Frame: Time from inclusion (Day 0) until Day 28 ]Evaluation with blood analysis
- cytotoxic response therapy [ Time Frame: Time from inclusion until relapse or death (until 5 years) ]Evaluation of cytotoxic response therapy with lenalidomide
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): NCT02525250
|Thomas PREBET, MD|
|Marseille, France, 13009|
|Principal Investigator:||Thomas PREBET, MD||Institut Paoli-Calmettes|