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Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor (PAMIR01)

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ClinicalTrials.gov Identifier: NCT02842333
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.

The aim of this prospective preliminary study is to evaluate the presence of UCP-specific Th1 responses in patients in complete remission of CML two years after end of Tyrosine Kinase Inhibitor (TKi) treatments.


Condition or disease Intervention/treatment Phase
Chronic Leukemia Other: Additional biological samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor
Actual Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: Additional biological samples

Blood samples will be realized at inclusion and 6 months after inclusion (optional).

Peripheral Blood Mononuclear Cells (PBMC) will be collected.

Other: Additional biological samples
Blood samples




Primary Outcome Measures :
  1. UCP-specific Th1 responses measured by ELISPOT assay [ Time Frame: at inclusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For cohort A :

    • patient with chronic myelogenous leukemia in chronic phase in deep molecular response (MR4.0) persistent for 2 years or more after end of TKi treatments
    • patient with total cessation of TKi treatment
    • signed written informed consent
  • For cohort B :

    • patient with chronic myelogenous leukemia in chronic phase, for whom a diagnosis of relapse was increased 1 year or less after stopping treatment with TKIs (inclusion of patient under TKi treatment after relapse is possible).
    • signed written informed consent

Exclusion Criteria (for all patients) :

  • patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (corticoids ≤ 10 mg/day is allowed)
  • active autoimmune diseases, HIV, hepatitis C or B virus
  • patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
  • patient under guardianship, curator or under the protection of justice.

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 ClinicalTrials.gov identifier (NCT number): NCT02842333


Contacts
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Contact: Fabrice LAROSA, Dr flarosa@chu-besancon.fr
Contact: Christophe BORG, Pr christophe.borg@efs.sante.fr

Locations
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France
Centre Hospitalier Régional Universitaire de Besançon Recruiting
Besançon, France
Contact: Fabrice LAROSA, Dr       flarosa@chu-besancon.fr   
Principal Investigator: Fabrice LAROSA, Dr         
CHU de Dijon Recruiting
Dijon, France
Contact: Denis CAILLOT, Dr       denis.caillot@chu-dijon.fr   
Principal Investigator: Denis CAILLOT, Dr         
CHU de Nice Recruiting
Nice, France
Contact: Laurence LEGROS, Dr       Legros.l@chu-nice.fr   
Principal Investigator: Laurence LEGROS, Dr         
Hôpital Saint-Louis Recruiting
Paris, France
Contact: Delphine REA, Dr       delphine.rea@aphp.fr   
Principal Investigator: Delphine REA, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02842333     History of Changes
Other Study ID Numbers: P/2015/263
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases