drugset / Trial / NCT01300793
Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide
Phase 1
Terminated
6 enrolled
University of California, San Francisco
Millennium Pharmaceuticals, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary objective of the study is to determine the maximum tolerated dose (MTD) of bortezomib (Velcade) in combination with rituximab, ifosfamide, carboplatin and etoposide for adult patients with relapsed or refractory aggressive B-cell lymphoma. The secondary objectives are to assess the tolerability and safety, the response rate, rate of autologous stem cell transplant and CD34+ progenitor cell collection and engraftment after treatment with this regimen.
Timeline
- Start
- 2007-05
- Primary completion
- 2011-07
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 0.7 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.5 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.7 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Background | Ifosfamide | Small molecule | 5 g | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |