Skip to content

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

Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02525250
Enrollment
14
Registered
2015-08-17
Start date
2012-12-31
Completion date
2015-01-31
Last updated
2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia or Myelodysplasic Syndrome

Keywords

Acute myeloid leukemia or myelodysplasic syndrome

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.

Interventions

PROCEDURERealization of 3 Blood samples during study during treatment with lenalidomide

Sponsors

Institut Paoli-Calmettes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of NK functionsTime from inclusion (Day 0) until Day 28Evaluation with blood analysis

Secondary

MeasureTime frameDescription
cytotoxic response therapyTime from inclusion until relapse or death (until 5 years)Evaluation of cytotoxic response therapy with lenalidomide

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026