drugset / Trial / NCT00738829
Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL
Phase 1/2
Completed
45 enrolled
Study Group of Medical Tumour Therapy (AGMT)
Celgene Corporation · collabRoche Pharma AG · collab
NaSingle-groupOpen-labelTreatment
Summary
The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.
Timeline
- Start
- 2008-10
- Primary completion
- 2012-01
- Completion
- 2012-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |
| Subject | Lenalidomide | Other / unclassified | 20 mg | — |
| Subject | Lenalidomide | Other / unclassified | 25 mg | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 40 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |