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NCT Number: NCT04942080

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

Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.

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Key information

Conditions

Myeloproliferative Neoplasm Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Essential Thrombocythemia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Myeloproliferative Disorders Primary Myelofibrosis Primary Myelofibrosis, Fibrotic Stage Primary Myelofibrosis, Prefibrotic Stage Thrombocythemia, Essential Thrombocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CALR allele burden quantification

Biological
  • 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

Primary outcomes

  1. 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.

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).

    Time frame: 3 years follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Emma BLANCHET

CONTACT

[email protected]

+33 2 41 35 63 38

Laurane COTTIN, Doctor

CONTACT

[email protected]

+33 2 41 35 53 53

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Ligue contre le cancer, France

Registry information

Acronym: CALRSUIVI

Important dates

Study start
2021
Primary completion
2027
Study completion
2030
First posted
Jun 28, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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