Status:
COMPLETED
Effects of Imatinib Mesylate in Polycythemia Vera
Lead Sponsor:
Niguarda Hospital
Conditions:
Polycythemia Vera
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 addit...
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 pro...
Eligibility Criteria
Inclusion
- Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
- Age \>18 years
- Signed written informed consent form
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00430066
Start Date
February 1 2007
End Date
September 1 2012
Last Update
October 8 2014
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