NCT02842333CompletedNot Applicable
Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor
Centre Hospitalier Universitaire de Besancon4 sites in 1 country57 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 57
- Locations
- 4
- Primary Endpoint
- UCP-specific Th1 responses measured by ELISPOT assay
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Additional biological samples
Experimental
Blood samples will be realized at inclusion and 6 months after inclusion (optional).
Peripheral Blood Mononuclear Cells (PBMC) will be collected.
Intervention: Additional biological samples (Other)
Outcomes
Primary Outcomes
UCP-specific Th1 responses measured by ELISPOT assay
Time Frame: at inclusion
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
Loading locations...
Similar Trials
Completed
Not Applicable
Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT02817178Centre Hospitalier Universitaire de Besancon258
Recruiting
Not Applicable
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic TumorsHematologic CancerSolid Tumor, ChildhoodSolid Tumor, AdultNCT05481502Gustave Roussy, Cancer Campus, Grand Paris160
Completed
Not Applicable
Red Cell Distribution With to Lymphocyte Ratio in Cardiac SurgeryCardiac SurgeryNCT05341037Ankara City Hospital Bilkent700
Completed
Not Applicable
Evaluation of Preexisting Immunity Markers in Human Tumor Tissue SampleCancerNCT00568867Stanford University300
Active, not recruiting
Not Applicable
Detect and Expunge Concealed Tumors of the LiverLiver CancerNCT06141564Johns Hopkins University360