Abstract
CERA is an erythropoiesis-stimulating agent (ESA) acting differently at the receptor level with a prolonged half-life. In this ongoing, multicenter, randomized, open-label, Phase II dose-response study, CERA was administered subcutaneously in a Q3W schedule to 93 transfusion-independent patients with aggressive (intermediate or high grade) B-cell non-Hodgkin’s lymphoma (NHL) and anemia receiving combination chemotherapy. Eligible patients met the following inclusion criteria: age ≥18 years, hemoglobin (Hb) <11 g/dL, combination chemotherapy scheduled to be administered throughout the 12-week treatment period, life expectancy >6 months, and Eastern Cooperative Oncology Group (ECOG) performance status grade 0–2. Major exclusion criteria included transferrin saturation <20% and platelet count <50 x 109/L. No patient had received an ESA in the 8 weeks prior to the first dose of CERA. Patients were randomized to receive CERA 2.1 μg/kg (n=31), 4.2 μg/kg (n=30), or 6.3 μg/kg (n=32) administered once every 3 weeks for 12 weeks. The primary efficacy variable was time-adjusted average change in Hb from baseline during 12 weeks, until end of initial treatment (last observed value before dose change or transfusion). Enrollment has been completed; the treatment phase of the trial is nearing conclusion. Demographics show similar baseline characteristics in all three patient subgroups [mean age: 62.9 years (2.1 μg/kg); 59.1 years (4.2 μg/kg); 64.3 years (6.3 μg/kg)]. Diffuse large B-cell lymphoma was the most common lymphoma in all three subgroups (87%, 70%, and 84% of patients in the 2.1, 4.2, and 6.3 μg/kg subgroups, respectively). To date, the majority of patients receive an anthracycline-containing chemotherapy regimen, either standard CHOP or CHOP plus rituximab. Preliminary efficacy and safety results will be presented. Ongoing assessments have indicated a safety profile consistent with that seen in patients with aggressive NHL and anemia receiving chemotherapy. This Phase II trial will help further characterize the ability of CERA to safely correct anemia when administered at an extended dosing interval (Q3W) to patients with aggressive NHL receiving chemotherapy.
Combination chemotherapy with mitoguazon, ifosfamide, MTX, etoposide (MIME) and G-CSF can efficiently mobilize PBPC in patients with Hodgkin’s and non-Hodgkin’s lymphoma