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Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis

Etude de l'efficacité et de la tolérance de l'interféron-pégylé Dans Les myélofibroses

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02910258
Acronym
PEG-MF
Enrollment
62
Registered
2016-09-22
Start date
2012-09-30
Completion date
2017-03-31
Last updated
2018-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Keywords

myelofibrosis, pegylated interferon

Brief summary

Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly α2a) are eligible to this prospective study. Biological and clinical parameters will be collected from the beginning of the drug use until last news. A non-opposition consent form need to be signed before entering this study.

Detailed description

In all centres interested, patients who were diagnosed for PMF/SMF can be treated with oral or sub-cutaneous drugs in order to reduce clinical symptoms and biological abnormalities belonging to these diseases. 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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary or secondary Myelofibrosis * Prescription of pegylated interferon α2a * Age \> 18 years-old

Exclusion criteria

* Other MPNs treated with pegylated interferon α2a * Patients treated for PMF or SMF but without pegylated interferon

Design outcomes

Primary

MeasureTime frameDescription
Efficiency of the interferon in MyelofibrosisEvaluation at 1 yearEvaluation on the presence or not of splenomegaly and physical signs or the normalization of blood counts.

Secondary

MeasureTime frameDescription
Rate of survival of patients with Myelofibrosis under interferonEvaluation at 5 yearsPatients dead or alive at this time
Tolerance of InterferonEvaluation at 1 yearPresence or not of psychiatric symptoms, cramps, hepatitic abnormalities

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026