Acute Myeloid Leukemia or Myelodysplasic Syndrome Clinical Trial
Official title:
Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies
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.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Thomas PREBET, MD | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Paoli-Calmettes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of NK functions | Evaluation with blood analysis | Time from inclusion (Day 0) until Day 28 | No |
| Secondary | cytotoxic response therapy | Evaluation of cytotoxic response therapy with lenalidomide | Time from inclusion until relapse or death (until 5 years) | No |