Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis (PEG-MF)

September 20, 2018 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • CHU d'Angers
      • Annecy, France
        • Hopital du genevois
      • Brest, France, 29609
        • CHRU de Brest
      • LE Mans, France
        • Centre Hospitalier Du Mans
      • Lens, France
        • Centre Hospitalier de LENS
      • Marseille, France
        • Institut Paoli Calmette
      • Morlaix, France, 29672
        • CH des Pays de Morlaix
      • Nice, France
        • Centre Hospitalier de Nice
      • Paris, France, 75475
        • AP-HP Hôpital Saint Louis
      • Quimper, France, 29000
        • CHIC de Cornouaille
      • Tours, France
        • Centre Hospitalier de Tours
      • Vandoeuvre-les-Nancy, France, 54511
        • Chu de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed for PMF or SMF and treated with pegykated interferon α2a

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Evaluation at 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEG-MF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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