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Completed

NCT Number: NCT02910258

Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Efficiency of the interferon in Myelofibrosis

    Time frame: Evaluation at 1 year

    Evaluation on the presence or not of splenomegaly and physical signs or the normalization of blood counts.

Secondary outcomes

  1. Rate of survival of patients with Myelofibrosis under interferon

    Time frame: Evaluation at 5 years

    Patients dead or alive at this time

  2. Tolerance of Interferon

    Time frame: Evaluation at 1 year

    Presence or not of psychiatric symptoms, cramps, hepatitic abnormalities

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: PEG-MF

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2016
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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