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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. Identifier: NCT00430066
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : October 8, 2014
Information provided by (Responsible Party):
Niguarda Hospital

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.

Condition or disease Intervention/treatment Phase
Polycythemia Vera Drug: Imatinib Mesylate Phase 2

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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera
Study Start Date : February 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Response duration [ Time Frame: 6-12 months ]
  2. Safety profile [ Time Frame: 6-12 months ]
  3. Reduction in platelet count and spleen size [ Time Frame: 6-12 months ]
  4. Reduction of incidence phlebotomies. [ Time Frame: 6-12 months ]
  5. Symptoms improvement in patients. [ Time Frame: 6-12 months ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00430066

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

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Responsible Party: Niguarda Hospital Identifier: NCT00430066     History of Changes
Other Study ID Numbers: CSTI571POLIVERA
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Bone Marrow Neoplasms
Protein Kinase Inhibitors
Polycythemia Vera
Hematologic Diseases
Hematologic Neoplasms
Neoplasms by Site
Bone Marrow Diseases
Myeloproliferative Disorders
Imatinib Mesylate
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action