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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)

C

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Additional biological samples
Experimental group
Description:
Blood samples will be realized at inclusion and 6 months after inclusion (optional). Peripheral Blood Mononuclear Cells (PBMC) will be collected.
Treatment:
Other: Additional biological samples

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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