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

Chronic Leukemia Clinical Trial

— PAMIR01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842333
• Other study ID #: P/2015/263
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 6, 2020

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 6, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• Additional biological samples
Blood samples

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Besançon	Besançon
France	CHU de Dijon	Dijon
France	CHU de Nice	Nice
France	Hôpital Saint-Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UCP-specific Th1 responses measured by ELISPOT assay		at inclusion