Chronic LeukemiaPAMIR01NCT02842333
Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor
A study testing Additional biological samples in people with Chronic Leukemia, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Leukemia
- What is being tested?
- Additional biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 4 sitesFrance
- Study dates
- May 2016to 6 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier Régional Universitaire de Besançon
Besançon
CHU de Dijon
Dijon
CHU de Nice
Nice
Hôpital Saint-Louis
Paris
About this study
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.
- Conditions
- Chronic Leukemia
- Being tested
- Additional biological samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional biological samplesOther
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Additional biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCP-specific Th1 responses measured by ELISPOT assay
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startMay 2016
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic LeukemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842333
- Sponsor's protocol ID
- P/2015/263
- Acronym
- PAMIR01
- Status last verified
- Apr 2023
- First submitted
- 20 Jul 2016
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02842333
- Acronym / sponsor ID
- PAMIR01 / P/2015/263
- Conditions
- Chronic Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional biological samples | Experimental | Other: Additional biological samplesBlood samples will be realized at inclusion and 6 months after inclusion (optional). Peripheral Blood Mononuclear Cells (PBMC) will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For cohort A :
- For cohort B :
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional biological samplesBlood samples | Other | Additional biological samples |
Primary outcome
UCP-specific Th1 responses measured by ELISPOT assay
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional biological samples in people with Chronic Leukemia, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCP-specific Th1 responses measured by ELISPOT assay (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.