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Completed

NCT Number: NCT00430066

Effects of Imatinib Mesylate in Polycythemia Vera

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.

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Key information

Conditions

Polycythemia Vera Bone Marrow Diseases Bone Marrow Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

imatinib mesylate

Drug

400 mg/die for 6 months

Primary outcomes

  1. Reduction of Haematocrit to less than 45%.

    Time frame: 6-12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Feb 1, 2007
Registry last updated
Oct 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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