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Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

NCT ID: NCT00039910

Last Updated: 2007-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2003-03-31

Brief Summary

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Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has been demonstrated to increase platelet counts. This study will test the safety and efficacy of the investigational drug in the prevention of thrombocytopenia in patients with recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL), or Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine, and Cisplatin) chemotherapy.

Detailed Description

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Conditions

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Non-Hodgkin Lymphoma Hodgkin Disease Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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(PN-152,243)/ PN-196,444

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL) or Hodgkin's disease and be scheduled for a minimum of 2 cycles of DHAP (Dexamethasone, high-dose Cytarabine and Cisplatin) chemotherapy

Exclusion Criteria

* Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

La Jolla, California, United States

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Pfizer Investigational Site

Loma Linda, California, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Orange, California, United States

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Pfizer Investigational Site

Tamarac, Florida, United States

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Pfizer Investigational Site

Chicago, Illinois, United States

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Chicago, Illinois, United States

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Pfizer Investigational Site

Lake Charles, Louisiana, United States

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Pfizer Investigational Site

Detroit, Michigan, United States

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Saint Joseph, Michigan, United States

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Southfield, Michigan, United States

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Jefferson City, Missouri, United States

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Jefferson City, Missouri, United States

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Omaha, Nebraska, United States

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Brooklyn, New York, United States

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Durham, North Carolina, United States

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Coos Bay, Oregon, United States

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Hershey, Pennsylvania, United States

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Bristol, Tennessee, United States

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Pfizer Investigational Site

Abingdon, Virginia, United States

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Pfizer Investigational Site

Abingdon, Virginia, United States

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Lebanon, Virginia, United States

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Pfizer Investigational Site

Marion, Virginia, United States

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Pfizer Investigational Site

East Melbourne, Victoria, Australia

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Pfizer Investigational Site

Paris, , France

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Pfizer Investigational Site

Tours, , France

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Pfizer Investigational Site

Thessaloniki, Macedonia, Greece

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Pfizer Investigational Site

Shatin, New Territories, Hong Kong

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Pfizer Investigational Site

Lodz, , Poland

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Pfizer Investigational Site

Warsaw, , Poland

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Pfizer Investigational Site

Moscow, , Russia

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Pfizer Investigational Site

Moscow, , Russia

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Pfizer Investigational Site

Singapore, , Singapore

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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United States Australia France Greece Hong Kong Poland Russia Singapore

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=444-ONC-0003-0019&StudyName=Safety+and+Efficacy+of+%28PN%2D152%2C243%29%2FPN%2D196%2C444+in+the+Prevention+of+Thrombocytopenia

To obtain contact information for a study center near you, click here.

Other Identifiers

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444-ONC-0003-0019

Identifier Type: -

Identifier Source: org_study_id