Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma
- Sponsor
- SymBio Pharmaceuticals
- Study ID
- NCT03372837
- Phase
- PHASE3
- Status
- Completed
Conditions
- Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGThe 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.
Study Details
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.
Key Dates
- Start date
- Jan 15, 2018
- Status verified
- Jun 2022
- Primary completion
- Dec 31, 2019
- Completion
- Dec 31, 2019
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: SyB L-0501The 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 Measure
Overall Response Rate [ Time Frame: up to 30 weeks ]