Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma
- Conditions
- Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL
- Interventions
- Registration Number
- NCT03372837
- Lead Sponsor
- SymBio Pharmaceuticals
- Brief Summary
The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with recurrent/relapsed 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 Day 2 and Day 3 in combination with rituximab at 375 mg/m\^2 on Day 1 of each 21-day cycle in patients with recurrent/relapsed diffuse large B-cell lymphoma.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SyB L-0501 Rituximab The administration of SyB L-0501 at 120 mg/m\^2/day by intravenous infusion on Day 2 and Day 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.
- Primary Outcome Measures
Name Time Method Overall Response Rate up to 30 weeks Complete Response (CR) + Partial Response (PR) Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) up to 30 weeks DOR is the period from the date of achieving CR, or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% Confidence Interval (CI ) were calculated using Greenwood's formula.
Complete Response (CR) Rate up to 30 weeks Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
Progression Free Survival (PFS) up to 30 weeks PFS = day of the first PFS event - day of start of study treatment + 1
Overall Survival (OS) up to 30 weeks. Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.
Trial Locations
- Locations (1)
Research Site
🇯🇵Yamagata, Japan