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

Phase 3

Completed

• Conditions: Non-Hodgkin Lymphoma; Hodgkin Disease; Thrombocytopenia

• Registration Number: NCT00039910
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2002-06-14
• Study First Submitted QC: 2002-06-14
• Study First Posted: 2002-06-17
• Study Completion: 2003-03
• Status Verified: 2006-09
• Last Update Submitted: 2007-05-03
• Last Update Posted: 2007-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore