A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.

The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.

Inclusion Criteria:

• Histologically confirmed Hodgkin's lymphoma or Non-Hodgkin's lymphoma receiving Q14, Q21, or Q28 day CHOP, ICE, ESHAP, or DHAP chemotherapy; with or without Rituximab
• Has adequate bone marrow function; platelet count > 100 x 10^9/L on the day of initiation of the on study chemotherapy of the next treatment cycle and absolute neutrophil count, ANC > or = 1 x 10^9/L, and hemoglobin > or = 9.5 g/dL
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Has adequate liver function
• must be able to receive the same chemotherapy regimen during the first treatment cycle as was received during the prior qualifying cycle
• must experience Common Terminology Criteria (CTC) grade 3 or 4 thrombocytopenia (platelet count < 50 x 10^9/L) as a result of the chemotherapy administered in the cycle immediately preceding study entry
• has serum creatinine concentration < or = 2 mg/dl

Exclusion Criteria:

• More that 1 prior relapse chemotherapy regimen
• Sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia
• Significant bleeding (CTC grade 3 or 4)
• History of thromboembolic disease
• Subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis B or C infection or to be HIV positive
• Use of any nitrosourea or mitomycin-C
• Has received any thrombocytopenic growth factor
• Has received a marrow or peripheral blood stem cell infusion
• Known hypersensitivity to any recombinant E. coli-derived product