Treatment of Polycythemia Vera With Gleevec

NCT ID: NCT01120821

Last Updated: 2010-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2007-06-30

Brief Summary

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

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.

Conditions

Polycythemia Vera

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study drug

Gleevec treatment

Group Type: EXPERIMENTAL

Gleevec

Intervention Type: DRUG

400 mg once daily for 12 months

Interventions

Gleevec

400 mg once daily for 12 months

Intervention Type: DRUG

Other Intervention Names

STI-571

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Weill Cornell Medical College

Principal Investigators

Richard Silver, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Countries

United States

Other Identifiers

CSTI571AUS41

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0702-375

Identifier Type: -

Identifier Source: org_study_id