Back to resultsStudy of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor (PAMIR01)
Primary Purpose
Chronic Leukemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional biological samples
Sponsored by
About this trial
This is an interventional other trial for Chronic Leukemia
Eligibility 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.
Sites / Locations
- Centre Hospitalier Régional Universitaire de Besançon
- CHU de Dijon
- CHU de Nice
- Hôpital Saint-Louis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Additional biological samples
Arm Description
Blood samples will be realized at inclusion and 6 months after inclusion (optional). Peripheral Blood Mononuclear Cells (PBMC) will be collected.
Outcomes
Primary Outcome Measures
UCP-specific Th1 responses measured by ELISPOT assay
Secondary Outcome Measures
Full Information
NCT ID
NCT02842333
First Posted
July 20, 2016
Last Updated
April 20, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02842333
Brief 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
Acronym
PAMIR01
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 6, 2020 (Actual)
Study Completion Date
October 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Leukemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Additional biological samples
Arm Type
Experimental
Arm Description
Blood samples will be realized at inclusion and 6 months after inclusion (optional).
Peripheral Blood Mononuclear Cells (PBMC) will be collected.
Intervention Type
Other
Intervention Name(s)
Additional biological samples
Intervention Description
Blood samples
Primary Outcome Measure Information:
Title
UCP-specific Th1 responses measured by ELISPOT assay
Time Frame
at inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Besançon
City
Besançon
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU de Nice
City
Nice
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor
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