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Treatment of Polycythemia Vera With Gleevec

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ClinicalTrials.gov Identifier: NCT01120821
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : May 17, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this research study is to evaluate the safety and effectiveness of patients with Polycythemia Vera treated with Gleevec.

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

Detailed Description:
Phlebotomy is a standard temporizing treatment for Polycythemia Vera. Performing repeated phlebotomies may lead to iron deficiency and can contribute to a rising platelet count. This may create additional problems, such as clots particularly in patients older than 50. There is reason to believe that the use of Gleevec may cause a decrease in the activity of the marrow so that patients may not require as many or any phlebotomies. Thus, spleen function may possibly improve by decreasing in size and patients' platelet counts may also improve.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec
Study Start Date : August 2002
Primary Completion Date : January 2007
Study Completion Date : June 2007


Arms and Interventions

Arm Intervention/treatment
Experimental: Study drug
Gleevec treatment
Drug: Gleevec
400 mg once daily for 12 months
Other Name: STI-571


Outcome Measures

Primary Outcome Measures :
  1. Stabilization of hematocrit [ Time Frame: Weekly for the first six week of treatment, then monthly for one year from study entry. ]
  2. Platelet count maintenance a therapeutic range. [ Time Frame: Weekly for the first six weeks of treatment, then monthly for one year from study entry. ]

Secondary Outcome Measures :
  1. Splenomegaly (if existent) [ Time Frame: Weekly for the first six weeks of treatment, then montly for one year from study entry. ]
  2. Quality of life, performance status, side effects and complications during treatment. [ Time Frame: Weekly for the first six weeks of treatment, then montly for one year from study entry. ]

Eligibility Criteria

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:

  • Patients have diagnosis of Polycythemia Vera (PV). Patients may have newly diagnosed PV.
  • Patients may have previously interferon-alfa treated PV with documented resistance, refractoriness or intolerance to interferon-alfa.
  • Patients may have PV with inadequate control on hydroxyurea.
  • Performance status of 0, 1, or 2
  • Adequate end organ function, defined as the following:

    1. total bilirubin <1.5 x upper limit of the normal range (ULN)
    2. SGOT (AST) and SGPT (ALT) < 2.5 x ULN
    3. creatinine < 1.5 x ULN
    4. ANC > 1.5 x 109/L
  • Written voluntary informed consent.

Exclusion Criteria:

  • Female patients who are pregnant or breast-feeding.
  • Patients receiving busulfan within 6 weeks of Study Day 1.
  • Patients receiving interferon-alpha within 4 weeks of Study Day 1.
  • Patients receiving hydroxyurea within 2 weeks of Study Day 1.
  • Patients with Grade III or IV cardiac problems as defined by the New York Heart Association Criteria.
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
  • Patients previously treated with Gleevec.
  • Serum erythropoietin level > or = 25 units/microliter
  • Abnormal O2 saturation (by pulse oximetry) or arterial pO2 (by arterial blood gas).
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): NCT01120821


Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Richard Silver, M.D. Weill Medical College of Cornell University
More Information

Responsible Party: Richard Silver, M.D., Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT01120821     History of Changes
Other Study ID Numbers: 0702-375
CSTI571AUS41 ( Other Grant/Funding Number: Novartis )
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: May 17, 2010
Last Verified: May 2010

Keywords provided by Weill Medical College of Cornell University:
PV

Additional relevant MeSH terms:
Polycythemia Vera
Polycythemia
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