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

Pfizer240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

240

Conditions

Non-Hodgkin Lymphoma Hodgkin Disease Thrombocytopenia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (38)

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

La Jolla, California, 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

Outcomes

Primary Outcomes

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

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