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Effects of Imatinib Mesylate in Polycythemia Vera

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430066
First Posted: February 1, 2007
Last Update Posted: October 8, 2014
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.
Information provided by (Responsible Party):
Niguarda Hospital
  Purpose

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.


Condition Intervention Phase
Polycythemia Vera Drug: Imatinib Mesylate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera

Resource links provided by NLM:


Further study details as provided by Niguarda Hospital:

Primary Outcome Measures:
  • Reduction of Haematocrit to less than 45%. [ Time Frame: 6-12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: February 2007
Study Completion Date: September 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imatinib Mesylate
400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)
Drug: Imatinib Mesylate
400 mg/die for 6 months

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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430066


Sponsors and Collaborators
Niguarda Hospital
Investigators
Study Director: Enrica Morra, MD Divisione di Ematologia - Ospedale Niguarda Ca' Granda
  More Information

Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT00430066     History of Changes
Other Study ID Numbers: CSTI571POLIVERA
First Submitted: January 31, 2007
First Posted: February 1, 2007
Last Update Posted: October 8, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Bone Marrow Diseases
Myeloproliferative Disorders
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action