Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical research study is to find the highest safe dose of AMG 531 that can
be given to treat thrombocytopenia (low platelet counts) in patients who have received
chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531.
Primary Objectives:
1. To determine the clinical safety and tolerability of AMG 531 administered following
chemotherapy (R-HyperCVAD alternating with R-Ara-C/MTX) in patients with non-Hodgkin's
lymphoma.
2. To determine an optimal biologic dose (OBD) of AMG 531 in patients receiving R-HyperCVAD
and R-Ara-C/MTX.
3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and
platelet recovery following chemotherapy(chemo).
Secondary Objectives:
1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route with
chemotherapy.