drugset / Trial / NCT00136565
Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the efficacy and the safety profile and toxicity of a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP \[doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone\]) in the treatment of previously untreated patients with peripheral T-cell lymphoma (PTCL).
Timeline
- Start
- 2006-01-08
- Primary completion
- 2011-04-18
- Completion
- 2011-04-18
Publications
- Background Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21.
- Background O'Connor OA, Wright J, Moskowitz C, Muzzy J, MacGregor-Cortelli B, Stubblefield M, Straus D, Portlock C, Hamlin P, Choi E, Dumetrescu O, Esseltine D, Trehu E, Adams J, Schenkein D, Zelenetz AD. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol. 2005 Feb 1;23(4):676-84. doi: 10.1200/JCO.2005.02.050. Epub 2004 Dec 21.
- Background Orlowski RZ. Proteasome inhibitors in cancer therapy. Methods Mol Biol. 2005;301:339-50. doi: 10.1385/1-59259-895-1:339.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | 10 mg | — |
| Subject | Bortezomib | Small molecule | 1.5 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 1200 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 75 mg/m2 | — |
| Subject | Prednisone | Other / unclassified | 60 mg/m2 | — |
| Subject | Vindesine | Small molecule | 2 mg/m2 | — |