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

Primary Purpose

Non-Hodgkin Lymphoma, Hodgkin Disease, Thrombocytopenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
(PN-152,243)/ PN-196,444
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Identify the effect of rhTPO on the number of platelet transfusions
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
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 health economics/cost effectiveness
Evaluate the impact of rhTPO prophylaxis on patient quality of life

Full Information

First Posted
June 14, 2002
Last Updated
May 3, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00039910
Brief Title
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma, Hodgkin Disease, Thrombocytopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
(PN-152,243)/ PN-196,444
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Identify the effect of rhTPO on the number of platelet transfusions
Title
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis
Title
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
Title
Assess the likelihood that patients were to have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycles
Title
Assess the safety of multiple IV doses of rhTPO
Title
Determine the occurrence and clinical implications of any anti-TPO antibodies
Title
Assess the antitumor activity of DHAP chemotherapy
Title
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
Title
Evaluate the impact of rhTPO prophylaxis on patient quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pfizer Investigational Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pfizer Investigational Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Pfizer Investigational Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Pfizer Investigational Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Pfizer Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Pfizer Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
90048
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Pfizer Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Pfizer Investigational Site
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Facility Name
Pfizer Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Pfizer Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Pfizer Investigational Site
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
Pfizer Investigational Site
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Pfizer Investigational Site
City
Lebanon
State/Province
Virginia
ZIP/Postal Code
24266
Country
United States
Facility Name
Pfizer Investigational Site
City
Marion
State/Province
Virginia
ZIP/Postal Code
24354
Country
United States
Facility Name
Pfizer Investigational Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Pfizer Investigational Site
City
Paris
Country
France
Facility Name
Pfizer Investigational Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Pfizer Investigational Site
City
Thessaloniki
State/Province
Macedonia
ZIP/Postal Code
540 07
Country
Greece
Facility Name
Pfizer Investigational Site
City
Shatin
State/Province
New Territories
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warsaw
Country
Poland
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore

12. IPD Sharing Statement

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

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