Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor

Not Applicable

Completed

• Conditions: Chronic Leukemia
• Interventions: Other: Additional biological samples

• Registration Number: NCT02842333
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-22
• Primary Completion: 2020-10-06
• Study Completion: 2020-10-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Additional biological samples	Additional biological samples	Blood samples will be realized at inclusion and 6 months after inclusion (optional). Peripheral Blood Mononuclear Cells (PBMC) will be collected.

Primary Outcome Measures

Name	Time	Method
UCP-specific Th1 responses measured by ELISPOT assay	at inclusion

Trial Locations

Locations (4)

Hôpital Saint-Louis; 🇫🇷 Paris, France

Centre Hospitalier Régional Universitaire de Besançon; 🇫🇷 Besançon, France

CHU de Nice; 🇫🇷 Nice, France

CHU de Dijon; 🇫🇷 Dijon, France