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.
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