Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI) (CALRSUIVI)

March 5, 2026 updated by: University Hospital, Angers
Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • Laurane COTTIN, Dr
      • Bordeaux, France, 33604
      • Brest, France, 29200
      • Cholet, France, 49300
      • Le Mans, France, 72037
        • Recruiting
        • CH Le Mans
        • Contact:
      • Morlaix, France, 29672
        • Recruiting
        • CH Morlaix
        • Contact:
      • Paris, France, 94010
        • Recruiting
        • AP-HP Henri Mondor
        • Contact:
      • Poitiers, France, 86021
      • Quimper, France, 29107
      • Tours, France, 37000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • patient with another active hematological disease or cancer at the time of diagnosis,
  • person subject to legal protection scheme or incapable of giving consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CALRSUIVI cohort
Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

Ligue contre le cancer, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2021

Primary Completion (Estimated)

April 28, 2027

Study Completion (Estimated)

April 28, 2030

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC21_0156

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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