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NCT Number: NCT02525250

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

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.

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Key information

Conditions

Acute Myeloid Leukemia or Myelodysplasic Syndrome Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas PREBET, MD

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Realization of 3 Blood samples during study during treatment with lenalidomide

Procedure

Primary outcomes

  1. Evaluation of NK functions

    Time frame: Time from inclusion (Day 0) until Day 28

    Evaluation with blood analysis

Secondary outcomes

  1. cytotoxic response therapy

    Time frame: Time from inclusion until relapse or death (until 5 years)

    Evaluation of cytotoxic response therapy with lenalidomide

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 17, 2015
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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