Clinical Trial: Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: University Hospital, Brest

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of survival of patients with Myelofibrosis under interferon [ Time Frame: Evaluation at 5 years ]
    Patients dead or alive at this time
  • Tolerance of Interferon [ Time Frame: Evaluation at 1 year ]
    Presence or not of psychiatric symptoms, cramps, hepatitic abnormalities


Original Secondary Outcome: Same as current

Information By: University Hospital, Brest

Dates:
Date Received: August 26, 2016
Date Started: September 2012
Date Completion: December 2017
Last Updated: September 19, 2016
Last Verified: September 2016