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

Not Applicable

Completed

• Conditions: Acute Myeloid Leukemia or Myelodysplasic Syndrome
• Interventions: Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide

• Registration Number: NCT02525250
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-04-03
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-07
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-17
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute myeloïd leukemia	Realization of 3 Blood samples during study during treatment with lenalidomide	Realization of 3 blood samples at day 0, day 15 and day 28.

Primary Outcome Measures

Name	Time	Method
Evaluation of NK functions	Time from inclusion (Day 0) until Day 28	Evaluation with blood analysis

Secondary Outcome Measures

Name	Time	Method
cytotoxic response therapy	Time from inclusion until relapse or death (until 5 years)	Evaluation of cytotoxic response therapy with lenalidomide

Trial Locations

Locations (1)

Thomas PREBET, MD; 🇫🇷 Marseille, France