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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02525250
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : August 17, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia or Myelodysplasic Syndrome Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies
Study Start Date : December 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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

Primary Outcome Measures :
  1. Evaluation of NK functions [ Time Frame: Time from inclusion (Day 0) until Day 28 ]
    Evaluation with blood analysis

Secondary Outcome Measures :
  1. cytotoxic response therapy [ Time Frame: Time from inclusion until relapse or death (until 5 years) ]
    Evaluation of cytotoxic response therapy with lenalidomide

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02525250

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Marseille, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
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Principal Investigator: Thomas PREBET, MD Institut Paoli-Calmettes

Additional Information:
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Responsible Party: Institut Paoli-Calmettes Identifier: NCT02525250    
Other Study ID Numbers: MDS-AML-NK / IPC-2012-007
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: July 2015
Keywords provided by Institut Paoli-Calmettes:
Acute myeloid leukemia or myelodysplasic syndrome
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents