Clinical trial · Interventional
Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)
NCT04942080CI-TRIAL-00104837CALRSUIVIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Essential Thrombocythemia | Essential Thrombocythemia | ONTOLOGY_EXACT | 0.98 |
| Myeloproliferative Neoplasm | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Primary Myelofibrosis, Fibrotic Stage | Overt Primary Myelofibrosis | ALIAS | 0.90 |
| Primary Myelofibrosis, Prefibrotic Stage | Prefibrotic Primary Myelofibrosis | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CALR allele burden quantification | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CALRSUIVI cohort
- interventionNames
- Biological: CALR allele burden quantification
Primary outcomes (1)
- 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.
- timeFrame
- 3 years follow-up
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDCottin 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. PMID 31710700