drugset / Trial / NCT00536341
Fludarabine, Rituximab, and Lenalidomide in Minimally Treated/Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
Phase 1/2
Completed
64 enrolled
SCRI Development Innovations, LLC
Celgene Corporation · collabGenentech, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I/II trial will combine fludarabine, rituximab, and lenalidomide in untreated or minimally treated (Phase I only) CLL patients, employing fixed doses of fludarabine and rituximab, using a schedule similar to that examined by investigators at MD Anderson (J Clin Oncol 23(18):4079-88, 2005). Given that the optimal dose and schedule is not currently known, this trial will perform a phase I component followed by a phase II examination to further explore this regimen's activity.
Timeline
- Start
- 2008-01
- Primary completion
- 2013-04
- Completion
- 2016-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fludarabine | Small molecule | 25 mg/m2 | — |
| Subject | Lenalidomide | Other / unclassified | 5 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 500 mg/m2 | — |