drugset / Trial / NCT04263584
Copanlisib in Combination With Rituximab and CHOP Chemotherapy in Patients With Previously Untreated DLBCL
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective, multicenter, non-randomized, open-label, phase II study to describe the efficacy of R-CHOP plus copanlisib including a safety run-in phase in order to detect early and common unexpected toxicities caused by the addition of copanlisib to the standard immuno-chemotherapy R-CHOP in patients with diffuse large B-cell lymphoma (DLBCL)
Timeline
- Start
- 2020-06-19
- Primary completion
- 2025-04
- Completion
- 2025-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Copanlisib | Small molecule | 45 mg | — |
| Subject | Copanlisib | Small molecule | 60 mg | — |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Background | Prednisolone | Other / unclassified | 500 mg | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | — |