NCT00998946

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

A Phase 2, Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
DRUG	Pralatrexate	Pralatrexate injection administered as intravenous (IV) push
DIETARY_SUPPLEMENT	Vitamin B12	1 mg intramuscular (IM) injection
DIETARY_SUPPLEMENT	Folic Acid	Oral 1 mg tablet

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-10-21
• Last updated: 2021-11-05
• Results posted: 2021-11-05

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study