drugset / Trial / NCT04661007
To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multicenter study to evaluate safety and tolerability, determine the RP2Ds of tafasitamab alone in Japanese participants with R/R NHL, or to evaluate efficacy and safety of tafasitamab in combination with lenalidomide in Japanese participants with R/R DLBCL, or tafasitimab in combination with lenalidomide plus R-CHOP in Japanese participants with previously untreated DLBC, or tafasitimab in combination with lenalidomide in Japanese participants with previously R/R DLBC.
Timeline
- Start
- 2020-12-15
- Primary completion
- 2025-07-01
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Subject | Parsaclisib | Unknown | 2.5 mg | — |
| Subject | Tafasitamab | Monoclonal antibody | 12 mg/kg | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Prednisolone | Other / unclassified | — | — |
| Background | Rituximab | Monoclonal antibody | — | — |
| Background | Vincristine | Small molecule | — | — |