drugset / Trial / NCT00998946

Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

NCT00998946

Phase 2 Completed 29 enrolled Spectrum Pharmaceuticals, Inc
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this participant population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).

Timeline

Start
2009-09
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Pralatrexate Other / unclassified 20 mg/m2 Intravenous
Subject Pralatrexate Other / unclassified 30 mg/m2 Intravenous