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Immunoevasive Tactics Employed by Myeloid Malignancy After Allogeneic Stem Cell Transplantation (EVADE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03964922
Recruitment Status : Not yet recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the only treatment available to cure acute myeloid leukemia and high risk myelodysplasia. Allo-HSCT has an anti-tumor effect (called the graft versus leukemia effect= GVL) mediated by donor lymphocytes. This GVL effect is often associated with graft-versus-host disease (GVHD). Several studies have shown that the relapse incidence is lower in patients developing chronic GVHD. These studies confirm the impact of donor immune system on leukemic residual cells. In fact, the relapse incidence increased in patients with no sign of GVHD. The investigators assume that leukemic cells probably use mechanisms to inhibit the allogeneic response. These escape mechanisms to immunosurveillance have been described in other malignancies. Out of context of the allo-HSCT, in acute myeloid leukemias and myelodysplasia, correlations between the severity of the disease and the presence of regulatory T cells (Tregs) or exhausted T cells (PD1 positive) in the bone marrow and in the blood of patients were described at the time of diagnosis or relapse. Myeloid Derived Suppressive Cells (MDSCs) have been described as capable of inducing Tregs and exhausted T cells in the tumor microenvironment.The investigators want to evaluate the role of myeloid suppressive cells in bone marrow after allo HSCT. They hypothesize that their presence in bone marrow and / or blood recipient is correlated to the relapse incidence.

Condition or disease Intervention/treatment Phase
Relapse Leukemia Allogeneic Stem Cell Transplantation Immune Evasion, Tumor Biological: blood sample Biological: bone marrow sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of the Immunoevasive Mecanisms and Especially Myeloid Suppressive Cells in the Medullar Microenvironment Employed by Myeloid Malignancy (AML and High Risk MDS) When Relapsing After Allogeneic Stem Cell Transplantation
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : November 1, 2022

Arm Intervention/treatment
Experimental: immune escape mecanims
Cohort study with a representative sample of patients
Biological: blood sample
20 ml at inclusion, and 20ml at 1, 3, 6 and 12 months after allo HSCT

Biological: bone marrow sample
3 ml at inclusion, and 3 ml at 1, 3, 6 and 12 months after allo HSCT

Primary Outcome Measures :
  1. Myeloid suppressive cells and relapse incidence [ Time Frame: 2 years ]

    To investigate the relationship between the percentage of myeloid derived suppressive cells (MDSCs) in total leukocytes in peripheral blood and the relapse incidence after allogeneic stem cell transplantation.

    The patients will be grouped according to median MDSC frequency values. Relapse incidence will be compared across the two groups (low and high frequency of MDSC).

Secondary Outcome Measures :
  1. Myeloid suppressive cells and the medullar microenvironment (regulatory T cells and mesenchymal stem cells) [ Time Frame: 2 years ]
    To correlate levels of bone marrow MDSC and regulatory T cells (Tregs) and exhausted T cells and the quality of mesenchymal cells in bone marrow.

  2. percentage of myeloid suppressive cells [ Time Frame: 2 years ]
  3. incidence of acute GVHD [ Time Frame: 2 years ]
  4. incidence of chronic GVHD [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with acute myeloid leukemia in complete cytological remission with intermediate or high risk prognosis according to ELN 2017
  • Patients with myelodysplasia according to the WHO 2016 definition, with IPSS ≥1.5 and disease status is : stable or in partial response or complete response according to IWG 2006.
  • Patients with indication of first allo-HSCT with a matched related or unrelated donor
  • Patients receiving non-myeloablative or reduced toxicity conditioning
  • Patients affiliated to a social security scheme
  • Patients who have received a complete information on the organization of the research and signed his informed consent

Exclusion Criteria:

  • Patients with an alternative donor (HLA 5/10 or unit cord blood)
  • Patients with another active cancer or a history of cancer diagnosed in the previous 5 years
  • Patients with uncontrolled infection at the time of inclusion, or with positive HIV (1 + 2) or HTLV (1 + 2), Hepatitis C or active hepatitis B
  • Patients referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.

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): NCT03964922

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Contact: Maud D'AVENI, MD +33383153289
Contact: Marie-Therese RUBIO, MD +33383153282

Sponsors and Collaborators
Central Hospital, Nancy, France
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Responsible Party: Central Hospital, Nancy, France Identifier: NCT03964922    
Other Study ID Numbers: 2019-A00842-55
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes