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Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by PV-Nord.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
PV-Nord
ClinicalTrials.gov Identifier:
NCT00241241
First received: October 17, 2005
Last updated: December 21, 2005
Last verified: October 2005
  Purpose

Interferon alfa is an effective treatment of polycythemia vera (PV), but about 20% of patients discontinue their treatment because of side effects and treatment schedule (three times per week administration). The pegylated form of interferon alfa-2a has shown a better tolerance in hepatitis patients and is administered only once a week. The purpose of this study is to determine efficacy and safety of pegylated interferon alfa-2a in the treatment of PV patients.


Condition Intervention Phase
Polycythemia Vera
Drug: pegylated interferon-alfa 2a
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Phase 2 Study of Efficacy and Safety of Pegylated Interferon-Alfa 2a in Polycythemia Vera Patients

Resource links provided by NLM:


Further study details as provided by PV-Nord:

Primary Outcome Measures:
  • response rate after one year of treatment

Secondary Outcome Measures:
  • safety
  • molecular response

Estimated Enrollment: 40
Study Start Date: September 2004
Estimated Study Completion Date: August 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • polycythemia vera diagnosed according to PVSG criteria, modified by Pearson
  • Previously untreated patients or patients treated by phlebotomy only or HU or pipobroman for less than 2 years
  • Age 18 to 65 years
  • Signed informed consent

Exclusion Criteria:

  • Contra indication for interferon
  • Severe renal or liver disease
  • ECOG performance status > 2
  • Pregnancy
  • Uncontrolled endocrine disorders except well regulated hyperthyroidism and diabetes
  • Severe concomitant heart failure or psychiatric disorder
  • Patients receiving an other investigational treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241241

Locations
France
Hopital Avicenne
Bobigny, France
Hopital Huriez
Lille, France
Hopital Dupuytren
Limoges, France
Hopital Lariboisiere
Paris, France
Hopital Saint-Louis
Paris, France
Sponsors and Collaborators
PV-Nord
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00241241     History of Changes
Other Study ID Numbers: PVN1
Study First Received: October 17, 2005
Last Updated: December 21, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by PV-Nord:
myeloproliferative disorder
polycythemia vera
interferon

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Interferon-alpha
Interferons
Peginterferon alfa-2a
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014