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

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Completed

CT.gov ID

NCT02525250

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia or Myelodysplasic Syndrome	Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acute myeloïd leukemia Realization of 3 blood samples at day 0, day 15 and day 28.	Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide

Arm

Intervention/Treatment

Experimental: Acute myeloïd leukemia

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas PREBET, MD	Marseille		France	13009

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

Principal Investigator: Thomas PREBET, MD, Institut Paoli-Calmettes

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

official web site of the sponsor

Publications

None provided.

Responsible Party:

Institut Paoli-Calmettes

ClinicalTrials.gov Identifier:

NCT02525250

Other Study ID Numbers:

MDS-AML-NK / IPC-2012-007

First Posted:

Aug 17, 2015

Last Update Posted:

Aug 17, 2015

Last Verified:

Jul 1, 2015

Keywords provided by Institut Paoli-Calmettes

Acute myeloid leukemia or myelodysplasic syndrome

Additional relevant MeSH terms:

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Lenalidomide

Study Results

No Results Posted as of Aug 17, 2015