Treatment of Polycythemia Vera With Gleevec

NCT01120821 | Completed Phase 2

• 2 other identifiers: 0702-375CSTI571AUS41
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycythemia Vera

Keywords

PV

Outcome Measures

Primary Outcomes (2)

• Stabilization of hematocrit

  Weekly for the first six week of treatment, then monthly for one year from study entry.

• Platelet count maintenance a therapeutic range.

  Weekly for the first six weeks of treatment, then monthly for one year from study entry.

Secondary Outcomes (2)

• Splenomegaly (if existent)

  Weekly for the first six weeks of treatment, then montly for one year from study entry.

• Quality of life, performance status, side effects and complications during treatment.

  Weekly for the first six weeks of treatment, then montly for one year from study entry.

Study Arms (1)

Study drug

EXPERIMENTAL

Gleevec treatment

Drug: Gleevec

Interventions

Gleevec DRUG

400 mg once daily for 12 months

Also known as: STI-571

Study drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Polycythemia Vera

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Richard Silver, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 11, 2010
• Study Start: August 1, 2002
• Primary Completion: January 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 17, 2010

Record last verified: 2010-05

Locations

US (1)