drugset / Trial / NCT00515138
A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant
NaSingle-groupOpen-labelTreatment
Summary
This study seeks to determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell, follicular grade III, transformed lymphoma). Subjects will be enrolled in cohorts of 3 at each bortezomib dose level, starting at 1 mg/m(2), and escalating to 1.3, 1.5, and 1.7 mg/m(2). Bortezomib will be given on days 1 (prior to rituximab) and 4, rituximab 375 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6.
Timeline
- Start
- 2007-05
- Primary completion
- 2011-11
- Completion
- 2011-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.5 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.7 mg/m2 | — |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | — |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |
| Background | Ifosfamide | Small molecule | 5 mg/m2 | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |