Viewing Study NCT02525250


Ignite Creation Date: 2025-12-24 @ 5:05 PM
Ignite Modification Date: 2025-12-28 @ 7:44 PM
Study NCT ID: NCT02525250
Status: COMPLETED
Last Update Posted: 2015-08-17
First Post: 2013-04-03
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Pilot Study Immunomonitoring Natural Killers Cells in Patients With Myeloid Malignancies Treated With Lenalidomide
Sponsor: Institut Paoli-Calmettes
Organization:

Study Overview

Official Title: Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies
Status: COMPLETED
Status Verified Date: 2015-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: