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 |
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Recruitment Status :
Recruiting
First Posted : June 28, 2021
Last Update Posted : November 3, 2022
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| 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 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: CALRSUIVI cohort |
Biological: CALR allele burden quantification
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- 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.
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| 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 |
| France | |
| CHU Angers | Recruiting |
| Angers, France | |
| Contact: Laurane COTTIN, Dr | |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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CALR Myeloproliferative Neoplasm Essential Thrombocythemia Primary Myelofibrosis Thrombocytosis |
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Primary Myelofibrosis Myeloproliferative Disorders Thrombocytosis Thrombocythemia, Essential Bone Marrow Diseases |
Hematologic Diseases Blood Platelet Disorders Blood Coagulation Disorders Hemorrhagic Disorders |