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Treatment of Polycythemia Vera With Gleevec

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01120821
First received: May 7, 2010
Last updated: May 14, 2010
Last verified: May 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Polycythemia Vera
 Drug: Gleevec
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Stabilization of hematocrit [ Time Frame: Weekly for the first six week of treatment, then monthly for one year from study entry. ] [ Designated as safety issue: No ]
  • Platelet count maintenance a therapeutic range. [ Time Frame: Weekly for the first six weeks of treatment, then monthly for one year from study entry. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Splenomegaly (if existent) [ Time Frame: Weekly for the first six weeks of treatment, then montly for one year from study entry. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2002
Study Completion Date: June 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study drug
Gleevec treatment
 Drug: Gleevec
400 mg once daily for 12 months
Other Name: STI-571

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Richard Silver, M.D., Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT01120821     History of Changes
Other Study ID Numbers: 0702-375, CSTI571AUS41
Study First Received: May 7, 2010
Last Updated: May 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
PV

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Imatinib
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013