Conditions: Non-Hodgkin's Lymphoma Lymphoma, Large Cell Diffuse, Mantle Cell Lymphoma, Lymphoma Follicular Lymphoma Large B-Cell, Diffuse
Keywords: Non-Hodgkin's lymphoma Lymphoma, Large B-Cell Diffuse, Mantle cell lymphoma, Lymphoma Follicular, Lymphoma Large B-Cell, Diffuse
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 63
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.

Detailed description:
Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m\^2/day on day2 and 3 in combination with rituximab at 375 mg/m\^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.

Arms:
arm 1: None

Interventions: intervention 1: SyB L-0501 intervention 2: Rituximab
Intervention descriptions: intervention 1: The administration of SyB L-0501 at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule.

SyB L-0501 60 mg/m\^2, 90 mg/m\^2 or 120 mg/m\^2/day on Day 2 and Day 3 will be followed by 18 days of observation. intervention 2: The administration of rituximab at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.

Protocol document: