Trials / Completed
CompletedNCT03900377
Phase I/II Study of SyB L-0501RI in Combination With Rituximab to Treat Lymphoma
A Multicenter, Open-label, Phase I/II Study to Investigate the Safety and Tolerability of SyB L-0501RI (Bendamustine Hydrochloride for Injection) Administered As an Intravenous (IV) Rapid Infusion Over 10 Minutes
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- SymBio Pharmaceuticals · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
For SyB L-0501RI administered by an intravenous rapid infusion in combination with rituximab, the safety will be investigated in previously untreated patients with low-grade B-cell non-Hodgkin's lymphoma (Lg-B-NHL) or mantle cell lymphoma (MCL), and the safety and tolerability will be investigated in patients with recurrent/refractory diffuse large B-cell lymphoma (DLBCL).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SyB L-0501RI | The specified dose of SyB L-0501RI and rituximab will be administered by intravenous rapid infusion over 10 minutes on specified days. |
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2020-09-09
- Completion
- 2021-02-26
- First posted
- 2019-04-03
- Last updated
- 2023-11-24
Locations
14 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03900377. Inclusion in this directory is not an endorsement.