Conditions: Lymphoma, B-Cell
Keywords: Relapsed Refractory Non-Hodgkin's
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 29
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.

Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.

Interventions: intervention 1: Pralatrexate intervention 2: Vitamin B12 intervention 3: Folic Acid
Intervention descriptions: intervention 1: Pralatrexate injection administered as intravenous (IV) push intervention 2: 1 mg intramuscular (IM) injection intervention 3: Oral 1 mg tablet

Protocol document: