Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis

Myelofibrosis Clinical Trial

— PEG-MF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910258
• Other study ID #: PEG-MF
• Status: Completed
• Start date: September 2012
• Est. completion date: March 2017

Study information

• Verified date: September 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary or secondary Myelofibrosis

• Prescription of pegylated interferon a2a

• Age > 18 years-old

Exclusion Criteria:

• Other MPNs treated with pegylated interferon a2a

• Patients treated for PMF or SMF but without pegylated interferon

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Locations

Country	Name	City	State
France	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	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (1)

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 peg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency of the interferon in Myelofibrosis	Evaluation on the presence or not of splenomegaly and physical signs or the normalization of blood counts.	Evaluation at 1 year
Secondary	Rate of survival of patients with Myelofibrosis under interferon	Patients dead or alive at this time	Evaluation at 5 years
Secondary	Tolerance of Interferon	Presence or not of psychiatric symptoms, cramps, hepatitic abnormalities	Evaluation at 1 year