Myeloproliferative NeoplasmCALRSUIVINCT04942080
Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)
A study testing CALR allele burden quantification in people with Myeloproliferative Neoplasm and Essential Thrombocythemia, run by University Hospital, Angers at 10 sites in France.
Trial summary
Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm, Essential Thrombocythemia, Primary Myelofibrosis, Prefibrotic Stage
- What is being tested?
- CALR allele burden quantification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 10 sitesFrance
- Study dates
- 28 Oct 2021to 28 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- adults (age ≥18 years),
- affiliated to the national social security system,
- with CALR mutated myeloproliferative neoplasm diagnosed between 2006 - 2020,
- for which at least one sample is available at the time of diagnosis or before cytoreductive treatment,
- who signed the consent to participate in the study,
- included, or consenting to be included, in the national clinical-biological database of France Intergroupe Syndrome Myéloprolifératifs (FIM).
Who cannot join
- patient with another active hematological disease or cancer at the time of diagnosis,
- person subject to legal protection scheme or incapable of giving consent.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CHU Angers
Angers
Laurane COTTIN, Dr
- Recruiting
Chu Bordeaux
Bordeaux, 33604
Olivier MANSIER, DOCTOR, +335 57 65 64 78, olivier.mansier@u-bordeaux.fr
- Recruiting
Chu Brest
Brest, 29200
ERIC LIPPERT, PROFESSOR, +332 98 34 70 33, eric.lippert@chu-brest.fr
- Recruiting
Ch Cholet
Cholet, 49300
CHARLES BESCOND, DOCTOR, +332 41 49 68 07, alain.zannetti@ch-cholet.fr
- Recruiting
Ch Le Mans
Le Mans, 72037
KAMEL LARIBI, DOCTOR, +332 43 43 43 60, klaribi@ch-lemans.fr
- Recruiting
Ch Morlaix
Morlaix, 29672
CHRISTOPHE NICOL, DOCTOR, +332 98 62 60 38, CNicol@ch-morlaix.fr
- Recruiting
AP-HP Henri Mondor
Paris, 94010
Lydia ROY, DOCTOR, +331 49 81 20 57, lydia.roy@aphp.fr
- Recruiting
Chu Poitiers
Poitiers, 86021
Jose Miguel TORREGROSA-DIAZ, DOCTOR, +335 49 44 44 44, jose-miguel.torregrosa-diaz@inserm.eu
- Recruiting
Ch Quimper
Quimper, 29107
Lenaig LE CLECH, DOCTOR, +332 98 52 61 50, l.leclech@ch-cornouaille.fr
- Recruiting
Chu Tours
Tours, 37000
Olivier HERAULT, PROFESSOR, +332 47 47 47 21, olivier.herault@univ-tours.fr
About this study
Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.
Read the detailed description
A first local study on 45 patients showed the prognostic impact of CALR mutation quantification in follow-up, independently of the European LeukemiaNet (ELN) prognostic score validated in this group of patients.
This study aims to evaluate a multicenter cohort of 260 patients, including all types of CALR-mutated MPNs and several follow-up samples, to model the temporal evolution of CALR allele burden.
Blood of MPN patients will be collected, at the time of diagnosis and for 3 years (max 1 sample/year), for the quantification of the CALR allele burden. During follow-up, a clinicobiological score to define the progression or not of the disease for each patient will be evaluated in Essential Thrombocythemia (ET) and MyeloFibrosis (MF).
- Conditions
- Myeloproliferative Neoplasm, Essential Thrombocythemia, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage
- Being tested
- CALR allele burden quantification
- Keywords
- CALR, Myeloproliferative Neoplasm, Essential Thrombocythemia, Primary Myelofibrosis, Thrombocytosis
- Medical subject headings
- Myeloproliferative Disorders, Thrombocythemia, Essential, Primary Myelofibrosis, Thrombocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALR allele burden quantificationBiological
- DNA extraction from blood sample for CALR mutation quantification (fragment analysis)
- at diagnosis and follow-up (inclusion period: 3 years)
- max 1 sample/year
- secondary outcome: mutational landscape by Next Generation Sequencing (NGS) analysis at diagnosis
| Study group | Role | What they receive |
|---|---|---|
| CALRSUIVI cohort | Experimental | Not described Receives: Biological: CALR allele burden quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
For each disease, Hazard Ratio of the different trajectories of CALR allele burden to explain the time to onset of disease progression by the clinicobiological score.
Clinicobiological score :
For ET, disease progression if ≥ 1 of:
- leukocytosis > 12 G/L or myelemia > 10% or erythroblasts > 1%,
- anemia or thrombocytopenia not related to drug toxicity,
- development or worsening of splenomegaly,
- development of thrombocytosis (platelets > 450 G/L) on cytoreductive therapy,
- poor disease control (at least one change in therapy for reasons other than adverse events),
- hematologic transformation or death related to hematologic pathology.
For MF, disease progression if ≥ 1 of:
- anemia < 100 g/L, neutropenia < 1 G/L, thrombocytopenia < 100 G/L and/or development of general signs not previously present or recurring after improvement,
- increase in leukocytosis > 25 G/L not previously present,
- appearance or aggravation of transfusion dependence,
- appearance (> 5 cm) or aggravation (> 50%) of splenomegaly,
- leukemic transformation or death related to the hematologic pathology.
Measured: 3 years follow-up
Secondary outcomes (1)
A multinomial logistic model will be performed to identify the characteristics associated with the different trajectories of CALR allele burden (pathology, treatment, additional mutations, type of CALR mutation).
Measured: 3 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start28 Oct 2021
- Primary completion28 Apr 2027 (estimated)
- Study completion28 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942080
- Sponsor's protocol ID
- 49RC21_0156
- Acronym
- CALRSUIVI
- Status last verified
- Mar 2026
- First submitted
- 9 Jun 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cottin L, Riou J, Orvain C, Ianotto JC, Boyer F, Renard M, Truchan-Graczyk M, Murati A, Jouanneau-Courville R, Allangba O, Mansier O, Burroni B, Rousselet MC, Quintin-Roue I, Martin A, Sadot-Lebouvier S, Delneste Y, Chretien JM, Hunault-Berger M, Blanchet O, Lippert E, Ugo V, Luque Paz D. Sequential mutational evaluation of CALR -mutated myeloproliferative neoplasms with thrombocytosis reveals an association between CALR allele burden evolution and disease progression. Br J Haematol. 2020 Mar;188(6):935-944. doi: 10.1111/bjh.16276. Epub 2019 Nov 11.
PubMed 31710700
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)
- ClinicalTrials.gov ID
- NCT04942080
- Acronym / sponsor ID
- CALRSUIVI / 49RC21_0156
- Conditions
- Myeloproliferative Neoplasm, Essential Thrombocythemia, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage
- Keywords
- CALR, Myeloproliferative Neoplasm, Essential Thrombocythemia, Primary Myelofibrosis, Thrombocytosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Ligue contre le cancer, France
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 28 Apr 2030 (estimated)
- First posted
- 28 Jun 2021 (actual)
- 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.
Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.
Detailed description
A first local study on 45 patients showed the prognostic impact of CALR mutation quantification in follow-up, independently of the European LeukemiaNet (ELN) prognostic score validated in this group of patients.
This study aims to evaluate a multicenter cohort of 260 patients, including all types of CALR-mutated MPNs and several follow-up samples, to model the temporal evolution of CALR allele burden.
Blood of MPN patients will be collected, at the time of diagnosis and for 3 years (max 1 sample/year), for the quantification of the CALR allele burden. During follow-up, a clinicobiological score to define the progression or not of the disease for each patient will be evaluated in Essential Thrombocythemia (ET) and MyeloFibrosis (MF).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CALRSUIVI cohort | Experimental | Biological: CALR allele burden quantification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults (age ≥18 years),
- affiliated to the national social security system,
- with CALR mutated myeloproliferative neoplasm diagnosed between 2006 - 2020,
- for which at least one sample is available at the time of diagnosis or before cytoreductive treatment,
- who signed the consent to participate in the study,
Key exclusion criteria (2 listed)
- patient with another active hematological disease or cancer at the time of diagnosis,
- person subject to legal protection scheme or incapable of giving consent.
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 |
|---|---|---|
| CALR allele burden quantification* DNA extraction from blood sample for CALR mutation quantification (fragment analysis) * at diagnosis and follow-up (inclusion period: 3 years) * max 1 sample/year * secondary outcome: mutational landscape by Next Generation Sequencing (NGS) analysis at diagnosis | Biological | CALRSUIVI cohort |
Primary outcome
For each disease, Hazard Ratio of the different trajectories of CALR allele burden to explain the time to onset of disease progression by the clinicobiological score.
Time frame: 3 years follow-up
Clinicobiological score : For ET, disease progression if ≥ 1 of: * leukocytosis > 12 G/L or myelemia > 10% or erythroblasts > 1%, * anemia or thrombocytopenia not related to drug toxicity, * development or worsening of splenomegaly, * development of thrombocytosis (platelets > 450 G/L) on cytoreductive therapy, * poor disease control (at least one change in therapy for reasons other than adverse events), * hematologic transformation or death related to hematologic pathology. For MF, disease progression if ≥ 1 of: * anemia < 100 g/L, neutropenia < 1 G/L, thrombocytopenia < 100 G/L and/or development of general signs not previously present or recurring after improvement, * increase in leukocytosis > 25 G/L not previously present, * appearance or aggravation of transfusion dependence, * appearance (> 5 cm) or aggravation (> 50%) of splenomegaly, * leukemic transformation or death related to the hematologic pathology.
1 secondary outcome
A multinomial logistic model will be performed to identify the characteristics associated with the different trajectories of CALR allele burden (pathology, treatment, additional mutations, type of CALR mutation).
Time frame: 3 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 31710700Cottin L, Riou J, Orvain C, Ianotto JC, Boyer F, Renard M, Truchan-Graczyk M, Murati A, Jouanneau-Courville R, Allangba O, Mansier O, Burroni B, Rousselet MC, Quintin-Roue I, Martin A, Sadot-Lebouvier S, Delneste Y, Chretien JM, Hunault-Berger M, Blanchet O, Lippert E, Ugo V, Luque Paz D. Sequential mutational evaluation of CALR -mutated myeloproliferative neoplasms with thrombocytosis reveals an association between CALR allele burden evolution and disease progression. Br J Haematol. 2020 Mar;188(6):935-944. doi: 10.1111/bjh.16276. Epub 2019 Nov 11.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CALR allele burden quantification in people with Myeloproliferative Neoplasm and Essential Thrombocythemia, run by University Hospital, Angers at 10 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurane COTTIN, Doctor (+33 2 41 35 53 53, Laurane.Cottin@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For each disease, Hazard Ratio of the different trajectories of CALR allele burden to explain the time to onset of disease progression by the clinicobiological score. (time frame: 3 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942080, which also lists 1 linked publication.
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 6 Mar 2026.