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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hodgkin Disease, Non-Hodgkin Lymphoma, Thrombocytopenia

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: (PN-152,243)/ PN-196,444|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |