- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00241241
Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera
Multicenter Phase 2 Study of Efficacy and Safety of Pegylated Interferon-alfa 2a in Polycythemia Vera Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Bobigny, France
- Hôpital Avicenne
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Lille, France
- Hopital Huriez
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Limoges, France
- Hôpital Dupuytren
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Paris, France
- Hôpital Lariboisière
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Paris, France
- Hôpital Saint-Louis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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response rate after one year of treatment
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Secondary Outcome Measures
Outcome Measure |
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safety
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molecular response
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Collaborators and Investigators
Sponsor
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
Publications and helpful links
General Publications
- Berk PD, Goldberg JD, Donovan PB, Fruchtman SM, Berlin NI, Wasserman LR. Therapeutic recommendations in polycythemia vera based on Polycythemia Vera Study Group protocols. Semin Hematol. 1986 Apr;23(2):132-43.
- Fruchtman SM, Mack K, Kaplan ME, Peterson P, Berk PD, Wasserman LR. From efficacy to safety: a Polycythemia Vera Study group report on hydroxyurea in patients with polycythemia vera. Semin Hematol. 1997 Jan;34(1):17-23. No abstract available.
- Kiladjian JJ, Bernard JF, Fenaux P. Is life expectancy of polycythemia vera patients clearly different from that of the general population? Am J Med. 2005 May;118(5):565; author reply 565-6. doi: 10.1016/j.amjmed.2004.12.026. No abstract available.
- Lengfelder E, Berger U, Hehlmann R. Interferon alpha in the treatment of polycythemia vera. Ann Hematol. 2000 Mar;79(3):103-9. doi: 10.1007/s002770050563.
- Streiff MB, Smith B, Spivak JL. The diagnosis and management of polycythemia vera in the era since the Polycythemia Vera Study Group: a survey of American Society of Hematology members' practice patterns. Blood. 2002 Feb 15;99(4):1144-9. doi: 10.1182/blood.v99.4.1144.
- Kiladjian JJ, Cassinat B, Chevret S, Turlure P, Cambier N, Roussel M, Bellucci S, Grandchamp B, Chomienne C, Fenaux P. Pegylated interferon-alfa-2a induces complete hematologic and molecular responses with low toxicity in polycythemia vera. Blood. 2008 Oct 15;112(8):3065-72. doi: 10.1182/blood-2008-03-143537. Epub 2008 Jul 23.
- Kiladjian JJ, Cassinat B, Turlure P, Cambier N, Roussel M, Bellucci S, Menot ML, Massonnet G, Dutel JL, Ghomari K, Rousselot P, Grange MJ, Chait Y, Vainchenker W, Parquet N, Abdelkader-Aljassem L, Bernard JF, Rain JD, Chevret S, Chomienne C, Fenaux P. High molecular response rate of polycythemia vera patients treated with pegylated interferon alpha-2a. Blood. 2006 Sep 15;108(6):2037-40. doi: 10.1182/blood-2006-03-009860. Epub 2006 May 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Bone Marrow Neoplasms
- Hematologic Neoplasms
- Polycythemia Vera
- Polycythemia
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- PVN1
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.
Clinical Trials on Polycythemia Vera
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PharmaEssentia Japan K.K.RecruitingPolycythemia Vera (PV)Japan
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Novartis PharmaceuticalsCompletedPolycythemia Vera (PV)United States
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PharmaEssentia Japan K.K.CompletedPolycythemia Vera (PV)Japan
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