drugset / Trial / NCT02758665
Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL
Phase 2
Completed
41 enrolled
University of Ulm
AbbVie · collabGerman CLL Study Group · collabJanssen-Cilag Ltd. · collabRoche Pharma AG · collab
NaSingle-groupOpen-labelTreatment
Summary
A prospective, open-label, multicentre phase-II trial of ibrutinib plus venetoclax plus obinutuzumab in physically fit (CIRS ≤ 6 \& normal creatinine clearance) and unfit (CIRS \> 6 \& creatinine clearance ≥ 50 ml/min) patients with previously untreated chronic lymphocytic leukemia (CLL) with TP53 deletion (17p-) and/or mutation
Timeline
- Start
- 2016-09
- Primary completion
- 2022-01
- Completion
- 2022-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 420 mg | — |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | — |