drugset / Trial / NCT03980002
A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective multicenter phase 2 study designed with the purpose to evaluate the response rate and safety of treatment with FCR/BR alternating with ibrutinib in treatment-naive patients with chronic lymphocytic leukemia.
Timeline
- Start
- 2019-05-15
- Primary completion
- 2022-12-15
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 90 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 250 mg/m2 | — |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | — |
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Subject | Rituximab | Monoclonal antibody | 500 mg/m2 | — |
| Subject | Thalidomide | Other / unclassified | — | — |