drugset / Trial / NCT04161248
Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
Phase 0
Active not recruiting
40 enrolled
Canadian Cancer Trials Group
AbbVie · collabIncyte Corporation · collabRoche Pharma AG · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to find the highest dose of a new drug, in combination with standard drugs, which can be tolerated without causing very severe side effects. The study treatment is new agents in combination with R-GDP or an equivalent regimen.
Timeline
- Start
- 2020-09-02
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glofitamab | Monoclonal antibody | 30 mg | — |
| Subject | Tafasitamab | Monoclonal antibody | 12 mg/kg | Intravenous |
| Subject | Venetoclax | Small molecule | 200 mg | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Subject | Venetoclax | Small molecule | 800 mg | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Dexamethasone | Small molecule | 40 mg | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 1400 mg | Subcutaneous |