drugset / Trial / NCT01420679

Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients

NCT01420679

Phase 3 Terminated 21 enrolled Spectrum Pharmaceuticals, Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.

Timeline

Start
2011-08
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pralatrexate Other / unclassified 30 mg/m2 Intravenous