Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
1 other identifier
interventional
240
8 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2000
Typical duration for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 14, 2002
CompletedFirst Posted
Study publicly available on registry
June 17, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedMay 4, 2007
September 1, 2006
June 14, 2002
May 3, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (38)
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
Pfizer Investigational Site
La Jolla, California, 92037, United States
Pfizer Investigational Site
Loma Linda, California, 92354, United States
Pfizer Investigational Site
Los Angeles, California, 90033-0804, United States
Pfizer Investigational Site
Los Angeles, California, 90036, United States
Pfizer Investigational Site
Los Angeles, California, 90048, United States
Pfizer Investigational Site
Los Angeles, California, 90089, United States
Pfizer Investigational Site
Orange, California, 92868, United States
Pfizer Investigational Site
Tamarac, Florida, 33321, United States
Pfizer Investigational Site
Chicago, Illinois, 60637, United States
Pfizer Investigational Site
Chicago, Illinois, 60640, United States
Pfizer Investigational Site
Lake Charles, Louisiana, 70601, United States
Pfizer Investigational Site
Detroit, Michigan, 48202, United States
Pfizer Investigational Site
Saint Joseph, Michigan, 49085, United States
Pfizer Investigational Site
Southfield, Michigan, 48076, United States
Pfizer Investigational Site
Jefferson City, Missouri, 65109, United States
Pfizer Investigational Site
Jefferson City, Missouri, 90048, United States
Pfizer Investigational Site
Omaha, Nebraska, 68198, United States
Pfizer Investigational Site
Brooklyn, New York, 11235, United States
Pfizer Investigational Site
Durham, North Carolina, 27705, United States
Pfizer Investigational Site
Coos Bay, Oregon, 97420, United States
Pfizer Investigational Site
Hershey, Pennsylvania, 17033, United States
Pfizer Investigational Site
Bristol, Tennessee, 37620, United States
Pfizer Investigational Site
Abingdon, Virginia, 24210, United States
Pfizer Investigational Site
Abingdon, Virginia, 24211, United States
Pfizer Investigational Site
Lebanon, Virginia, 24266, United States
Pfizer Investigational Site
Marion, Virginia, 24354, United States
Pfizer Investigational Site
East Melbourne, Victoria, 3002, Australia
Pfizer Investigational Site
Paris, France
Pfizer Investigational Site
Tours, 37044, France
Pfizer Investigational Site
Thessaloniki, Macedonia, 540 07, Greece
Pfizer Investigational Site
Shatin, New Territories, Hong Kong
Pfizer Investigational Site
Lodz, 93-510, Poland
Pfizer Investigational Site
Warsaw, Poland
Pfizer Investigational Site
Moscow, 115478, Russia
Pfizer Investigational Site
Moscow, 125167, Russia
Pfizer Investigational Site
Singapore, 169608, Singapore
Pfizer Investigational Site
Singapore, 169610, Singapore
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 14, 2002
First Posted
June 17, 2002
Study Start
July 1, 2000
Study Completion
March 1, 2003
Last Updated
May 4, 2007
Record last verified: 2006-09