drugset / Trial / NCT02200848
Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
NaSingle-groupOpen-labelTreatment
Summary
This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on patients with CLL/SLL. The hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.
Timeline
- Start
- 2014-04
- Primary completion
- 2017-03-27
- Completion
- 2017-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 280 mg | — |
| Subject | Ibrutinib | Small molecule | 420 mg | — |
| Subject | Lenalidomide | Other / unclassified | 2.5 mg | — |
| Subject | Lenalidomide | Other / unclassified | 5 mg | — |
| Subject | Lenalidomide | Other / unclassified | 10 mg | — |
| Subject | Lenalidomide | Other / unclassified | 15 mg | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |