drugset / Trial / NCT02692248
Ibrutinib in Patients With Refractory/Relapsed Non-GCB Diffuse Large B-cell Lymphoma Non-candidates to ASCT
NaSingle-groupOpen-labelTreatment
Summary
Multicentric phase II trial to evaluate efficacy and safety of ibrutinib in combination with rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maintenance in patients with refractory/relapsed non-GCB DLBCL non candidates to autologous stem-cell transplantation (ASCT) An extensive biological study will be conducted in order to further characterize this population of DLBCL patients and correlate the response obtained with the biological profile of the tumor.
Timeline
- Start
- 2016-04-07
- Primary completion
- 2018-11-08
- Completion
- 2021-01-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 100 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |