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

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ClinicalTrials.gov Identifier: NCT04942080
Recruitment Status : Recruiting
First Posted : June 28, 2021
Last Update Posted : November 3, 2022
Sponsor:
Collaborator:
Ligue contre le cancer, France
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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Brief Summary:
Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.

Condition or disease Intervention/treatment Phase
Myeloproliferative Neoplasm Essential Thrombocythemia Primary Myelofibrosis, Prefibrotic Stage Primary Myelofibrosis, Fibrotic Stage Biological: CALR allele burden quantification Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)
Actual Study Start Date : October 28, 2021
Estimated Primary Completion Date : April 28, 2023
Estimated Study Completion Date : April 28, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04942080


Contacts
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Contact: Laurane COTTIN, Doctor +33 2 41 35 53 53 Laurane.Cottin@chu-angers.fr
Contact: Emma BLANCHET +33 2 41 35 63 38 EmBlanchet@chu-angers.fr

Locations
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France
CHU Angers Recruiting
Angers, France
Contact: Laurane COTTIN, Dr         
Sponsors and Collaborators
University Hospital, Angers
Ligue contre le cancer, France
More Information
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Publications:

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04942080    
Other Study ID Numbers: 49RC21_0156
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
CALR
Myeloproliferative Neoplasm
Essential Thrombocythemia
Primary Myelofibrosis
Thrombocytosis
Additional relevant MeSH terms:
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Primary Myelofibrosis
Myeloproliferative Disorders
Thrombocytosis
Thrombocythemia, Essential
Bone Marrow Diseases
 Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders