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

Institut Paoli-Calmettes

Status: Completed

Conditions: Acute Myeloid Leukemia or Myelodysplasic Syndrome

Treatments: Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02525250

MDS-AML-NK / IPC-2012-007

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

14 participants in 1 patient group

Acute myeloïd leukemia

Experimental group

Description:

Realization of 3 blood samples at day 0, day 15 and day 28.

Treatment:

Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide