Trials / Completed
CompletedNCT03372837
Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma
A Multicenter, Open-label Phase III Study of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed Diffuse Large B-Cell Lymphoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- SymBio Pharmaceuticals · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab | 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. |
Timeline
- Start date
- 2018-01-15
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2017-12-14
- Last updated
- 2023-04-18
Locations
29 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03372837. Inclusion in this directory is not an endorsement.