drugset / Trial / NCT00254410
FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years
Phase 2
Completed
30 enrolled
M.D. Anderson Cancer Center
Genentech, Inc. · collabOSI Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and mitoxantrone plus rituximab, with the growth factor pegylated filgrastim, will improve the response to treatment, and increase the time this response lasts, for patients with previously untreated CLL. The safety of this combination will also be studied.
Timeline
- Start
- 2005-03-14
- Primary completion
- 2017-09-14
- Completion
- 2017-09-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 250 mg/m2 | Intravenous |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 6 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |