Study Evaluating TRU-015 in B-Cell Non-Hodgkin's Lymphoma
This is a study to evaluate the safety and efficacy of TRU-015 in treatment of B-cell Non-Hodgkin's Lymphoma (NHL).
TRU-015 is also currently being evaluated in multiple clinical studies for the treatment of autoimmune disorders. Over 300 patients have received TRU-015 in these studies, and the data observed to date support its safety in patients with autoimmune disorders.
Safety of an escalating dose of 4 weekly infusions of TRU-015 will be evaluated in subjects with relapsed NHL (see inclusion criteria for subtypes).
Once a maximum tolerated dose (MTD) is confirmed or maximum dose to be studied is determined to be safe and well tolerated, an expanded cohort of subjects with relapsed follicular NHL will be evaluated for efficacy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1/2 Dose Escalation Study of TRU-015 in Subjects With Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma|
- Safety: physical examinations, laboratory tests, adverse events. Maximum Tolerated Dose: dose-limiting toxicities. Efficacy: disease response and progression status per International Response Criteria for NHL. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- Objective response rate in subjects with relapsed follicular NHL. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Intravenous administration; 400 mg, 700 mg, or 1000 mg; 1x/week dosing for 4 weeks
|United States, California|
|Duarte, California, United States, 91010|
|San Diego, California, United States, 92121|
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02111|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|Buffalo, New York, United States, 14263|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|