Myeloproliferative Neoplastic Diseases Observatory From Brest

Primary Myelofibrosis Clinical Trial

— OBENE  

Official title:

Observatoire Brestois Des Néoplasies Myéloprolifératives

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02897297
• Other study ID #: OBENE
• Status: Recruiting
• Start date: September 2015
• Est. completion date: September 2025

Study information

• Verified date: May 2019
• Source: University Hospital, Brest
• Contact: Jean-Christophe Ianotto
• Email: jean-christophe.Ianotto[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

All patients diagnosed or followed in Brest University Hospital for Philadelphia negative myeloproliferative neoplasms will be included in this observational study.

Myeloproliferative neoplasms recorded included: polycythemia vera, essential Thrombocythemia and Primary Myelofibrosis.

This is a not interventional study. Alive patients need to sign a non-opposition consent form.

Patients will be followed until last news (death, change of reference centre...).

Description:

In this retrospective and prospective study, clinical and biological data from diagnosis until last news will be recorded.

Clinical data collected: patients and disease characteristics at the time of the diagnosis, disease and mutational status, cardio-vascular risk factors, history of thrombosis and cancer.

Biological data collected: hemogram and bone marrow results if available. During the follow-up new data will be noted: treatment changes (reasons of change and type of drug), thrombotic events (localization, date and hemogram), phenotypic evolutions (type and date), death (date and etiology).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with essentiel thrombocythemia, polycythemia vera or primary myelofibrosis

• Signature of the non-opposition consent form

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Polycythemia
• Polycythemia Vera
• Primary Myelofibrosis
• Thrombocythemia, Essential
• Thrombocytosis

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (9)

Delluc A, Lacut K, Pan-Petesch B, Galinat H, Lippert E, Ianotto JC. Statin exposure and thrombosis risk in patients with myeloproliferative neoplasms. Thromb Res. 2018 Jul;167:57-59. doi: 10.1016/j.thromres.2018.05.014. Epub 2018 May 16. — View Citation

Ianotto JC, Chauveau A, Boyer-Perrard F, Gyan E, Laribi K, Cony-Makhoul P, Demory JL, de Renzis B, Dosquet C, Rey J, Roy L, Dupriez B, Knoops L, Legros L, Malou M, Hutin P, Ranta D, Benbrahim O, Ugo V, Lippert E, Kiladjian JJ. Benefits and pitfalls of peg — View Citation

Ianotto JC, Couturier MA, Galinat H, Mottier D, Berthou C, Guillerm G, Lippert E, Delluc A. Administration of direct oral anticoagulants in patients with myeloproliferative neoplasms. Int J Hematol. 2017 Oct;106(4):517-521. doi: 10.1007/s12185-017-2282-5. — View Citation

Le Calloch R, Lacut K, Le Gall-Ianotto C, Nowak E, Abiven M, Tempescul A, Dalbies F, Eveillard JR, Ugo V, Giraudier S, Guillerm G, Lippert E, Berthou C, Ianotto JC. Non-adherence to treatment with cytoreductive and/or antithrombotic drugs is frequent and — View Citation

Le Clech L, Sakka M, Meskar A, Kerspern H, Eveillard JR, Berthou C, Buors C, Lippert E, Guillerm G, Quintin-Roué I, Carré JL, Ianotto JC. The presence of monoclonal gammopathy in Ph-negative myeloproliferative neoplasms is associated with a detrimental ef — View Citation

Le Gall-Ianotto C, Brenaut E, Gouillou M, Lacut K, Nowak E, Tempescul A, Berthou C, Ugo V, Carré JL, Misery L, Ianotto JC. Clinical characteristics of aquagenic pruritus in patients with myeloproliferative neoplasms. Br J Dermatol. 2017 Jan;176(1):255-258 — View Citation

Mahé K, Delluc A, Chauveau A, Castellant P, Mottier D, Dalbies F, Berthou C, Guillerm G, Lippert E, Ianotto JC. Incidence and impact of atrial arrhythmias on thrombotic events in MPNs. Ann Hematol. 2018 Jan;97(1):101-107. doi: 10.1007/s00277-017-3164-x. E — View Citation

Mansier O, Luque Paz D, Ianotto JC, Le Bris Y, Chauveau A, Boyer F, Conejero C, Fitoussi O, Riou J, Adiko D, Touati M, Chauzeix J, Viallard JF, Béné MC, Giraudier S, Ugo V, Lippert E. Clinical and biological characterization of MPN patients harboring two — View Citation

Mollard LM, Chauveau A, Boyer-Perrard F, Douet-Guilbert N, Houot R, Quintin-Roué I, Couturier MA, Dagorne A, Malou M, Le Calloch R, Luycx O, Thepot S, Hunault M, Guillerm G, Berthou C, Ugo V, Lippert É, Ianotto JC. Outcome of Ph negative myeloproliferativ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	occurrence of death	10 years
Secondary	Incidence of evolutions	occurrence of transformation into polycythemia vera, secondary myelofibrosis, myelodysplastic syndrome or acute leukemia	10 years
Secondary	Incidence of thromboses	occurrence of arterial or venous thrombotic events	10 years