Effects of Imatinib Mesylate in Polycythemia Vera

Polycythemia Vera Clinical Trial

Official title:

Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430066
• Other study ID #: CSTI571POLIVERA
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2007
• Last updated: October 7, 2014
• Start date: February 2007
• Est. completion date: September 2012

Study information

• Verified date: October 2014
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2012
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycythemia
• Polycythemia Vera

Intervention

Drug:
• Imatinib Mesylate
400 mg/die for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Haematocrit to less than 45%.		6-12 months	Yes
Secondary	Response duration		6-12 months	No
Secondary	Safety profile		6-12 months	Yes
Secondary	Reduction in platelet count and spleen size		6-12 months	Yes
Secondary	Reduction of incidence phlebotomies.		6-12 months	Yes
Secondary	Symptoms improvement in patients.		6-12 months	Yes