Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera
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|ClinicalTrials.gov Identifier: NCT00241241|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : October 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Polycythemia Vera||Drug: pegylated interferon-alfa 2a||Phase 2|
The aim of PV treatment is to reduce the risk of vascular thrombosis without enhancing the long-term risk of evolution toward myelofibrosis or MDS/AL. Although currently controversial, phlebotomies have been shown in the old PVSG01 study to increase the risk of both thrombosis and myelofibrosis. On the other hand, currently available cytoreductive treatments have been shown to efficiently reduce the thrombotic risk, but were demonstrated (32P, busulfan, chlorambucil) or suspected (pipobroman, hydroxyurea) to enhance the risk of evolution to MDS/AL. In fact, the main widely used cytoreductive treatment, when indicated, is hydroxyurea (HU). This drug is very efficient to control myeloproliferation with a response rate of 80 to 90%. It is generally well tolerated, even if long term toxicity leads to treatment change in 10% of cases. Although no prospective study has yet clearly demonstrated its leukemogenic potential in PV, a non-leukemogenic alternative treatment is highly warranted, especially for younger patient.
Interferon (IFN) alpha is a promising agent in PV both because of good efficacy and absence of leukemogenic risk. Expanded experience with IFN-alpha was recently reported, showing a control of erythrocytosis in approximately 75% of patients. A similar percentage of patients also have resolution of disease-related symptoms, in particular a reduction in spleen size and relief from intractable pruritus. In some cases, long-term persisting remissions after treatment discontinuation have been observed as well as demonstration of eradication of the myeloproliferative clone. However, 20% of patients may not tolerate the treatment because of side effects. Furthermore, the treatment schedule (three times per week administration) may be a factor reducing long-term compliance to this drug.
In this regard, pegylated-IFN could be a major drug in PV. The weekly administration and better tolerance by comparison to IFN reported in hepatitis patients could allow to obtain results similar to chemotherapy in terms of compliance to treatment and efficacy, with a major advantage, its lack of mutagenicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase 2 Study of Efficacy and Safety of Pegylated Interferon-alfa 2a in Polycythemia Vera Patients|
|Study Start Date :||September 2004|
|Primary Completion Date :||October 2006|
|Study Completion Date :||January 2008|
- response rate after one year of treatment
- molecular response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241241
|Principal Investigator:||Jean-Jacques Kiladjian, MD||PV-Nord|
|Study Chair:||Pierre Fenaux, MD, PhD||PV-Nord|
|Study Chair:||Christine Chomienne, MD, PhD||PV-Nord|
|Study Chair:||Sylvia Bellucci, MD||PV-Nord|
|Study Chair:||Bruno Cassinat, MD||PV-Nord|
|Study Chair:||Marie-Jose Grange, MD||PV-Nord|
|Study Chair:||Nathalie Cambier, MD||PV-Nord|
|Study Chair:||Jean-Francois Bernard, MD||PV-Nord|
|Study Chair:||Philippe Rousselot, MD||PV-Nord|