drugset / Trial / NCT02436707
Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma
Phase 2
Active not recruiting
129 enrolled
Canadian Cancer Trials Group
Janssen, LP · collabKaryopharm Therapeutics Inc · collabRoche Pharma AG · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
Timeline
- Start
- 2015-10-27
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 35 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 1.75 g/kg | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Etoposide | Small molecule | 350 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Selinexor | Other / unclassified | 40 mg | Oral |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 1.75 g/kg | Intravenous |
| Background | G-CSF | Unknown | 300 ug | Subcutaneous |
| Background | G-CSF | Unknown | 480 ug | Subcutaneous |
| Background | G-CSF | Unknown | 600 ug | Subcutaneous |