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

May 3, 2007 updated by: Pfizer

Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Recurrent or Refractory Non-Burkitt's, Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease Receiving DHAP (Dexamethasone, High-Dose Cytarabine and Cisplatin) Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

240

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Victoria
  - East Melbourne, Victoria, Australia, 3002
    - Pfizer Investigational Site
France
- - Paris, France
    - Pfizer Investigational Site
  - Tours, France, 37044
    - Pfizer Investigational Site
Greece
- Macedonia
  - Thessaloniki, Macedonia, Greece, 540 07
    - Pfizer Investigational Site
Hong Kong
- New Territories
  - Shatin, New Territories, Hong Kong
    - Pfizer Investigational Site
Poland
- - Lodz, Poland, 93-510
    - Pfizer Investigational Site
  - Warsaw, Poland
    - Pfizer Investigational Site
Russian Federation
- - Moscow, Russian Federation, 115478
    - Pfizer Investigational Site
  - Moscow, Russian Federation, 125167
    - Pfizer Investigational Site
Singapore
- - Singapore, Singapore, 169608
    - Pfizer Investigational Site
  - Singapore, Singapore, 169610
    - Pfizer Investigational Site
United States
- Arizona
  - Phoenix, Arizona, United States, 85023
    - Pfizer Investigational Site
- California
  - La Jolla, California, United States, 92037
    - Pfizer Investigational Site
  - Loma Linda, California, United States, 92354
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90048
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90033-0804
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90036
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90089
    - Pfizer Investigational Site
  - Orange, California, United States, 92868
    - Pfizer Investigational Site
- Florida
  - Tamarac, Florida, United States, 33321
    - Pfizer Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Pfizer Investigational Site
  - Chicago, Illinois, United States, 60640
    - Pfizer Investigational Site
- Louisiana
  - Lake Charles, Louisiana, United States, 70601
    - Pfizer Investigational Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Pfizer Investigational Site
  - Southfield, Michigan, United States, 48076
    - Pfizer Investigational Site
  - St. Joseph, Michigan, United States, 49085
    - Pfizer Investigational Site
- Missouri
  - Jefferson City, Missouri, United States, 65109
    - Pfizer Investigational Site
  - Jefferson City, Missouri, United States, 90048
    - Pfizer Investigational Site
- Nebraska
  - Omaha, Nebraska, United States, 68198
    - Pfizer Investigational Site
- New York
  - Brooklyn, New York, United States, 11235
    - Pfizer Investigational Site
- North Carolina
  - Durham, North Carolina, United States, 27705
    - Pfizer Investigational Site
- Oregon
  - Coos Bay, Oregon, United States, 97420
    - Pfizer Investigational Site
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Pfizer Investigational Site
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Pfizer Investigational Site
- Virginia
  - Abingdon, Virginia, United States, 24210
    - Pfizer Investigational Site
  - Abingdon, Virginia, United States, 24211
    - Pfizer Investigational Site
  - Lebanon, Virginia, United States, 24266
    - Pfizer Investigational Site
  - Marion, Virginia, United States, 24354
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the effectiveness of primary prophylaxis with intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy-induced thrombocytopenia.

Secondary Outcome Measures

Outcome Measure
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
Identify the effect of rhTPO on the number of platelet transfusions
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis
Assess the likelihood that patients were to have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycles
Assess the safety of multiple IV doses of rhTPO
Determine the occurrence and clinical implications of any anti-TPO antibodies
Assess the antitumor activity of DHAP chemotherapy
Evaluate the impact of rhTPO prophylaxis on patient quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

June 14, 2002

First Submitted That Met QC Criteria

June 14, 2002

First Posted (Estimate)

June 17, 2002

Study Record Updates

Last Update Posted (Estimate)

May 4, 2007

Last Update Submitted That Met QC Criteria

May 3, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

444-ONC-0003-0019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.