NCT02842333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

May 25, 2025

Status Verified

April 1, 2023

Enrollment Period

4.4 years

First QC Date

July 20, 2016

Last Update Submit

May 21, 2025

Conditions

Chronic Leukemia

Outcome Measures

Primary Outcomes (1)

  • UCP-specific Th1 responses measured by ELISPOT assay

    at inclusion

Study Arms (1)

Additional biological samples

EXPERIMENTAL

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

Interventions

Additional biological samplesOTHER

Blood samples

Additional biological samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 :
  • signed written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Nice

Nice, France

Location

Hôpital Saint-Louis

Paris, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 22, 2016

Study Start

May 1, 2016

Primary Completion

October 6, 2020

Study Completion

October 6, 2020

Last Updated

May 25, 2025

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)