MyelofibrosisPEG-MFNCT02910258
Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis
An observational study of Myelofibrosis, run by University Hospital, Brest at 12 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- How many people
- 62 participants
- Where
- 12 sitesFrance
- Study dates
- Sep 2012to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed for PMF or SMF and treated with pegykated interferon α2a
Who may be able to join
- Primary or secondary Myelofibrosis
- Prescription of pegylated interferon α2a
- Age > 18 years-old
Who cannot join
- Other MPNs treated with pegylated interferon α2a
- Patients treated for PMF or SMF but without pegylated interferon
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU d'Angers
Angers, 49000
Hopital du genevois
Annecy
CHRU de Brest
Brest, 29609
Centre Hospitalier du Mans
Le Mans
Centre Hospitalier de Lens
Lens
Institut Paoli Calmette
Marseille
CH des pays de Morlaix
Morlaix, 29672
Centre Hospitalier de Nice
Nice
AP-HP Hôpital Saint Louis
Paris, 75475
CHIC de Cornouaille
Quimper, 29000
Centre Hospitalier de Tours
Tours
CHU de Nancy
Vandœuvre-lès-Nancy, 54511
About this study
Official title: 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.
Read the 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.
- Conditions
- Myelofibrosis
- Keywords
- myelofibrosis, pegylated interferon
- Medical subject headings
- Primary Myelofibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of the interferon in Myelofibrosis
Evaluation on the presence or not of splenomegaly and physical signs or the normalization of blood counts.
Measured: Evaluation at 1 year
Secondary outcomes (2)
Rate of survival of patients with Myelofibrosis under interferon
Patients dead or alive at this time
Measured: Evaluation at 5 years
Tolerance of Interferon
Presence or not of psychiatric symptoms, cramps, hepatitic abnormalities
Measured: Evaluation at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startSep 2012
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Ianotto, MD, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910258
- Sponsor's protocol ID
- PEG-MF
- Acronym
- PEG-MF
- Status last verified
- Sep 2018
- First submitted
- 26 Aug 2016
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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 pegylated interferon-alpha2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.
PubMed 29217781
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de l'efficacité et de la tolérance de l'interféron-pégylé Dans Les myélofibroses
- ClinicalTrials.gov ID
- NCT02910258
- Acronym / sponsor ID
- PEG-MF / PEG-MF
- Conditions
- Myelofibrosis
- Keywords
- myelofibrosis, pegylated interferon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed for PMF or SMF and treated with pegykated interferon α2a
Key inclusion criteria (3 listed)
- Primary or secondary Myelofibrosis
- Prescription of pegylated interferon α2a
- Age > 18 years-old
Key exclusion criteria (2 listed)
- Other MPNs treated with pegylated interferon α2a
- Patients treated for PMF or SMF but without pegylated interferon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
2 secondary outcomes
Rate of survival of patients with Myelofibrosis under interferon
Time frame: Evaluation at 5 years
Tolerance of Interferon
Time frame: Evaluation at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Results publication: PubMed 29217781Ianotto 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 pegylated interferon-alpha2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe Ianotto, MD study director
CHRU de Brest
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis, run by University Hospital, Brest at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of the interferon in Myelofibrosis (time frame: Evaluation at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.