Pilot Study Immunomonitoring Natural Killers Cells in Patients With Myeloid Malignancies Treated With Lenalidomide

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies

Conditions
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Acute Myeloid Leukemia or Myelodysplasic Syndrome

Intervention / Treatment
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* Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 years and above, 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: Allogeneic patients beyond, Patient deprived of liberty or under supervision of a guardian, Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute myeloïd leukemia<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of NK functions | Evaluation with blood analysis | Time from inclusion (Day 0) until Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytotoxic response therapy | Evaluation of cytotoxic response therapy with lenalidomide | Time from inclusion until relapse or death (until 5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myeloid leukemia or myelodysplasic syndrome