drugset / Trial / NCT01538641

Phase II Evaluation of Gemcitabine- Rituximab-Oxaliplatin Combination (GROC) in Relapsed Aggressive Lymphomas

NCT01538641 ↗

Phase 2 Completed 43 enrolled Auxilio Mutuo Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

Study Proposal: Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol, Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior activity as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin is more attractive and should be explored in this group of disorders. Based on these data and considering the advantage of its favorable toxicity profile, we propose a phase II study in patients with either refractory or relapsing aggressive non-Hodgkin's lymphomas including peripheral T-cell lymphomas which are known to have a poor outcome when compared with equivalent aggressive B-cell lymphomas.

Timeline

Start
2003-10
Primary completion
2007-08
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 —
Subject Oxaliplatin Small molecule 100 mg/m2 —
Subject Rituximab Monoclonal antibody 375 mg/m2 —

Indications