PAMIR01: Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Unknown status
CT.gov ID
NCT02842333
Collaborator
(none)
120
Enrollment
4
Locations
1
Arm
48
Anticipated Duration (Months)
30
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Additional biological samples
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor
Actual Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Additional biological samples

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

Other: Additional biological samples
Blood samples

Outcome Measures

Primary Outcome Measures

  1. UCP-specific Th1 responses measured by ELISPOT assay [at inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Centre Hospitalier Régional Universitaire de BesançonBesançonFrance
2CHU de DijonDijonFrance
3CHU de NiceNiceFrance
4Hôpital Saint-LouisParisFrance

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT02842333
Other Study ID Numbers:
  • P/2015/263
First Posted:
Jul 22, 2016
Last Update Posted:
Jul 2, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Results

No Results Posted as of Jul 2, 2018