drugset / Trial / NCT01754857
Bendamustine and Rituximab Induction Therapy and Maintenance Rituximab and Lenalidomide in Previously Untreated CLL/SLL
Phase 2
Completed
36 enrolled
University of Wisconsin, Madison
Celgene Corporation · collabGenentech, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
The investigators propose a treatment strategy where patients are treated with induction chemoimmunotherapy consisting of rituximab + bendamustine for 6 cycles, followed by initiation of maintenance rituximab and lenalidomide among patients achieving an objective response (i.e., at least stable disease with some tumor shrinkage) to induction therapy. The goal of maintenance therapy will be to capitalize on the cytoreduction following induction chemotherapy with a maintenance regimen that has also shown promising activity in CLL, in order to allow for improved PFS in this population.
Timeline
- Start
- 2013-11-12
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Lenalidomide | Other / unclassified | 5 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |