drugset / Trial / NCT00151281

Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma

NCT00151281

Phase 2 Completed 25 enrolled Weill Medical College of Cornell University
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

EvaluationDrugModalityDoseRoute
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

Indications