Primary Myelofibrosis Clinical Trial
— PHEMOPOfficial title:
Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes-PHEMOP
Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 19, 2027 |
Est. primary completion date | October 19, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of PV, ET, pre-myelofibrosis or primary myelofibrosis according to WHO 2022 criteria (including BOM for ET, premyelofibrosis and primary myelofibrosis) - Patient who has not received treatment specific to hemopathy at the time of sampling - Obtaining the signature of consent to participate in the study - Patient having consented to be included in the "Malignant Hemopathy" collection of Angers University Hospital and in FIMBANK database Exclusion Criteria: - Person not affiliated to a social security scheme or beneficiary of such a scheme - Patient with another hemopathy or another active cancer at the time of diagnosis - Minor patient at diagnosis (< 18 years old) - Patient not capable or without agreement from the guardian or legal representative |
Country | Name | City | State |
---|---|---|---|
France | GOUBAND Agathe | Angers | Maine Et Loire |
France | BESCOND Charles | Cholet | Maine Et Loire |
France | TRUCHAN-GRACZYK Malgorzata | Saumur | Maine Et Loire |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | WHO 2016 criteria for polycythemia vera, prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis | Assessment of the monocytic signature against the WHO diagnosis (AUC will be determined) | Day 0 | |
Secondary | Identify correlation between the monocytic signature and driver mutations (mutation in JAK2, CALR or MPL gene). | The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis | 24 months | |
Secondary | Identify correlation between the monocytic signature and the grade of fibrosis | The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis The monocytic signature will be compared between the different stages of fibrosis (WHO definition for fibrosis grading) | 24 months | |
Secondary | prognostic value of the monocytic signature using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6 | Evaluate the prognostic value of the monocytic signature for treatment response
The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6 : Complete response: normal blood counts Partial response: platelets between 400 and 600 G/L No response: absence of complete or partial response |
12, 24 months | |
Secondary | Prognostic value of the monocyte signature for disease worsening according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022 | Evaluate the prognostic value of the monocyte signature for disease worsening The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis
Disease worsening criteria according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022): - Worsening is defined by the presence of at least one of the following criteria: i) leukocytosis >12 G/L or presence of immature granulocytes >2% or erythroblasts >1%; (ii) anemia (hemoglobin <12 g/dL in a woman or <13 g/dL in man) not related to treatment toxicity; (iii) thrombocytopenia (platelet count <150G/L) not related to treatment toxicity; (iv) onset of splenomegaly or progression of pre-existing splenomegaly; (v) thrombocytosis despite cytoreductive therapy |
24 months | |
Secondary | leukemia-free survival | The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis Outcome measure : leukemia-free survival and myelofibrosis-free survival Evaluate the prognostic value of the monocytic signature for hematological progression (acute myeloid leukemia or myelofibrosis) | 24 months | |
Secondary | myelofibrosis-free survival | The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis Outcome measure : leukemia-free survival and myelofibrosis-free survival Evaluate the prognostic value of the monocytic signature for hematological progression (acute myeloid leukemia or myelofibrosis) | 24 months | |
Secondary | Monocytes parameters for hematological progression | Evaluate the prosnostic value of monocytes parameters for hematological progression Hematological free survival wil be evaluated by cox models | 24 months |
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