Overview

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

Status:
Completed

Trial end date:
2003-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Criteria

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