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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- UCP-specific Th1 responses measured by ELISPOT assay [ Time Frame: at inclusion ]
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
|Contact: Fabrice LAROSA, Drfirstname.lastname@example.org|
|Contact: Christophe BORG, Premail@example.com|
|Centre Hospitalier Régional Universitaire de Besançon||Recruiting|
|Contact: Fabrice LAROSA, Dr firstname.lastname@example.org|
|Principal Investigator: Fabrice LAROSA, Dr|
|CHU de Dijon||Recruiting|
|Contact: Denis CAILLOT, Dr email@example.com|
|Principal Investigator: Denis CAILLOT, Dr|
|CHU de Nice||Recruiting|
|Contact: Laurence LEGROS, Dr Legros.firstname.lastname@example.org|
|Principal Investigator: Laurence LEGROS, Dr|
|Contact: Delphine REA, Dr email@example.com|
|Principal Investigator: Delphine REA, Dr|