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
1 other identifier
interventional
40
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2004
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedOctober 21, 2015
October 1, 2015
2.1 years
October 17, 2005
October 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate after one year of treatment
Secondary Outcomes (2)
safety
molecular response
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PV-Nordlead
Study Sites (5)
Hopital Avicenne
Bobigny, France
Hopital Huriez
Lille, France
Hopital Dupuytren
Limoges, France
Hopital Lariboisiere
Paris, France
Hopital Saint-Louis
Paris, France
Related Publications (7)
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.
PMID: 3704665BACKGROUNDFruchtman 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.
PMID: 9025158BACKGROUNDKiladjian 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.
PMID: 15866263BACKGROUNDLengfelder 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.
PMID: 10803930BACKGROUNDStreiff 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.
PMID: 11830459BACKGROUNDKiladjian 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.
PMID: 18650451DERIVEDKiladjian 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.
PMID: 16709929DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 18, 2005
Study Start
September 1, 2004
Primary Completion
October 1, 2006
Study Completion
January 1, 2008
Last Updated
October 21, 2015
Record last verified: 2015-10