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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02842333
Acronym
PAMIR01
Enrollment
57
Registered
2016-07-22
Start date
2016-05-31
Completion date
2020-10-06
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Leukemia

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.

Interventions

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
UCP-specific Th1 responses measured by ELISPOT assayat inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026