A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
Chemotherapy-Induced Thrombocytopenia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
About this trial
This is an interventional supportive care trial for Chemotherapy-Induced Thrombocytopenia focused on measuring NHL, chemotherapy induced thrombocytopenia, CIT, ICE, RICE, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, CHOP, ESHAP, DHAP, R-CHOP, R-ESHAP, R-DHAP
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Experimental
Single Arm: AMG 531 Dose-Escalating Cohort Study