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Trial record 15 of 23 for:    "Bone Marrow Cancer" | "Protein Kinase Inhibitors"

Effects of Imatinib Mesylate in Polycythemia Vera

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00430066
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital

Tracking Information
First Submitted Date  ICMJE January 31, 2007
First Posted Date  ICMJE February 1, 2007
Last Update Posted Date October 8, 2014
Study Start Date  ICMJE February 2007
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
Reduction of Haematocrit to less than 45%. [ Time Frame: 6-12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
  • Reduction of Haematocrit to less than 45%.
  • Reduction in platelet count and spleen size.
  • Reduction of incidence phlebotomies.
  • Symptoms improvement in patients.
Change History Complete list of historical versions of study NCT00430066 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
  • Response duration [ Time Frame: 6-12 months ]
  • Safety profile [ Time Frame: 6-12 months ]
  • Reduction in platelet count and spleen size [ Time Frame: 6-12 months ]
  • Reduction of incidence phlebotomies. [ Time Frame: 6-12 months ]
  • Symptoms improvement in patients. [ Time Frame: 6-12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
  • Response duration
  • Safety profile
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Imatinib Mesylate in Polycythemia Vera
Official Title  ICMJE Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera
Brief Summary

The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.

The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.

Detailed Description Hematocrit <45% in men or <42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycythemia Vera
Intervention  ICMJE Drug: Imatinib Mesylate
400 mg/die for 6 months
Study Arms  ICMJE Experimental: Imatinib Mesylate
400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)
Intervention: Drug: Imatinib Mesylate
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: June 18, 2012)
9
Original Enrollment  ICMJE
 (submitted: January 31, 2007)
10
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
  • Age >18 years
  • Signed written informed consent form

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Creatinine >3 max NV
  • Bilirubin >3 max NV
  • AST/ALT >3 max NV
  • Concomitant and severe psychiatric disorder
  • Concomitant neoplastic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Not Provided
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT00430066
Other Study ID Numbers  ICMJE CSTI571POLIVERA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Niguarda Hospital
Study Sponsor  ICMJE Niguarda Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Enrica Morra, MD Divisione di Ematologia - Ospedale Niguarda Ca' Granda
PRS Account Niguarda Hospital
Verification Date October 2014

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