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)

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Chronic Leukemia

Treatments

Other: Additional biological samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02842333

P/2015/263

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.