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Trial record 2 of 18 for:    "Bone Marrow Cancer" | "interferons"

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
Sponsor:
Information provided by:
PV-Nord

Tracking Information
First Submitted Date  ICMJE October 17, 2005
First Posted Date  ICMJE October 18, 2005
Last Update Posted Date October 21, 2015
Study Start Date  ICMJE September 2004
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
response rate after one year of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00241241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
  • safety
  • molecular response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera
Official Title  ICMJE Multicenter Phase 2 Study of Efficacy and Safety of Pegylated Interferon-alfa 2a in Polycythemia Vera Patients
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycythemia Vera
Intervention  ICMJE Drug: pegylated interferon-alfa 2a
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 17, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00241241
Other Study ID Numbers  ICMJE PVN1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE PV-Nord
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account PV-Nord
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP