drugset / Trial / NCT00151281
Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective: Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed. Secondary Objectives: 1. Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma. 2. Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy. 3. Assess the quality of life of patients receiving RT-PEPC treatment
Timeline
- Start
- 2004-11
- Primary completion
- 2009-12
- Completion
- 2011-04-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg | — |
| Subject | Etoposide | Small molecule | 50 mg | — |
| Subject | Prednisone | Other / unclassified | 20 mg | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Subject | Thalidomide | Other / unclassified | 50 mg | — |
| Subject | Thalidomide | Other / unclassified | 100 mg | — |
| Subject | procarbazine | Small molecule | 50 mg | — |