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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-10-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Additional biological samples

Blood samples will be realized at inclusion and 6 months after inclusion (optional).

Peripheral Blood Mononuclear Cells (PBMC) will be collected.

Group Type EXPERIMENTAL

Additional biological samples

Intervention Type OTHER

Blood samples

Interventions

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Additional biological samples

Blood samples

Intervention Type OTHER

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No