Myeloproliferative Neoplasm Clinical Trial
— CALRSUIVIOfficial title:
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.
Status | Recruiting |
Enrollment | 260 |
Est. completion date | April 28, 2026 |
Est. primary completion date | April 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Angers | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers | Ligue contre le cancer, France |
France,
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-Roué I, Martin A, Sadot-Lebouvier S, Delneste Y, Chrétien 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
3 years follow-up | |
Secondary | 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). | 3 years follow-up |
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