Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis
NCT ID: NCT02910258
Last Updated: 2018-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
62 participants
OBSERVATIONAL
2012-09-30
2017-03-31
Brief Summary
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A non-opposition consent form need to be signed before entering this study.
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Detailed Description
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Pegylated-interferon is one of the better weapons that can be used in these cases. These treatments are well known and used from many years in french hematological centres.
The investigators to collect clinical and biological data from patients treated with pegylated-interferon α2a (the most use) in case of PMF/SMF in order to assess efficacity and tolerance to this drug. The prescription of the product and the dose are under the responsibility of each practician.
Clinical data collected: disease and patients characteristics at the time of diagnosis and at the beginning of the drug use, spleen and liver size, presence of constitutive symptoms, transfusion needs.
Biological data collected: complete hemogram, CD34+ cells count, allele burden of JAK2V617F and calreticulin clones if DNA samples are collected.
These data will be collected avery 3 months during the two first years and every 6 months after.
The investigators also recorded adverse side effects if significative, the concomitant use of hematological drugs (cytoreductive treatments, ASE...), modalities of prescription of the drugs and the reason for stopping the drug and etiology of death if happened.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Prescription of pegylated interferon α2a
* Age \> 18 years-old
Exclusion Criteria
* Patients treated for PMF or SMF but without pegylated interferon
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Jean-Christophe Ianotto, MD
Role: STUDY_DIRECTOR
CHRU de Brest
Locations
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CHU d'Angers
Angers, , France
Hopital du genevois
Annecy, , France
CHRU de Brest
Brest, , France
Centre Hospitalier du Mans
Le Mans, , France
Centre Hospitalier de Lens
Lens, , France
Institut Paoli Calmette
Marseille, , France
CH des pays de Morlaix
Morlaix, , France
Centre Hospitalier de Nice
Nice, , France
AP-HP Hôpital Saint Louis
Paris, , France
CHIC de Cornouaille
Quimper, , France
Centre Hospitalier de Tours
Tours, , France
CHU de Nancy
Vandœuvre-lès-Nancy, , France
Countries
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References
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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 pegylated interferon-alpha2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.
Other Identifiers
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PEG-MF
Identifier Type: -
Identifier Source: org_study_id
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