drugset / Trial / NCT00481871

Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies

NCT00481871

Phase 1/2 Completed 119 enrolled Acrotech Biopharma Inc.
RandomizedSingle-groupOpen-labelTreatment

Summary

This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's macroglobulinemia. This study is being done to find doses of the combination of pralatrexate and gemcitabine with vitamin B12 and folic acid that can be safely given to patients with these types of lymphoma and explore the effectiveness of the treatment.

Timeline

Start
2007-05
Primary completion
2011-05
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 400 mg/m2 Intravenous
Subject Gemcitabine Small molecule 600 mg/m2 Intravenous
Subject Pralatrexate Other / unclassified 10 mg/m2 Intravenous
Subject Pralatrexate Other / unclassified 15 mg/m2 Intravenous