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

Non-Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039910
• Other study ID #: 444-ONC-0003-0019
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2002
• Last updated: May 3, 2007
• Start date: July 2000
• Est. completion date: March 2003

Study information

• Verified date: September 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• (PN-152,243)/ PN-196,444

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	East Melbourne	Victoria
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Tours
Greece	Pfizer Investigational Site	Thessaloniki	Macedonia
Hong Kong	Pfizer Investigational Site	Shatin	New Territories
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Warsaw
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
United States	Pfizer Investigational Site	Abingdon	Virginia
United States	Pfizer Investigational Site	Abingdon	Virginia
United States	Pfizer Investigational Site	Bristol	Tennessee
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Coos Bay	Oregon
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Hershey	Pennsylvania
United States	Pfizer Investigational Site	Jefferson City	Missouri
United States	Pfizer Investigational Site	Jefferson City	Missouri
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	Lake Charles	Louisiana
United States	Pfizer Investigational Site	Lebanon	Virginia
United States	Pfizer Investigational Site	Loma Linda	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Marion	Virginia
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Southfield	Michigan
United States	Pfizer Investigational Site	St. Joseph	Michigan
United States	Pfizer Investigational Site	Tamarac	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  France,  Greece,  Hong Kong,  Poland,  Russian Federation,  Singapore, 

Outcome

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

External Links

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