Trial information
A Study of Ocrelizumab in Patients With Follicular Non-Hodgkin's Lymphoma (NHL)
Status: Completed
Protocol number: BO18414
Sponsor: F Hoffmann-La Roche Ltd/Global Development
Company division: Pharmaceutical
Official Scientific Title: An open-label, dose-escalating study of ocrelizumab to determine its safety and tolerability in patients with follicular non-Hodgkin's lymphoma
Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy of ocrelizumab in patients with progressive follicular NHL. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 45.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Non-Hodgkin's Lymphoma
Intervention type: Drug
Intervention name: ocrelizumab
Primary outcome: 1. Safety:Adverse events and laboratory assessments
Key secondary outcomes: 1. PK/PD and anti-tumor efficacy: overall response rate, progression-free survival, event-free survival
Inclusion criteria:
- adult patients >=18 years of age;
- follicular NHL;
- documented history of a response, or stable disease of >6 months' duration, to a rituximab-containing regimen that was the last treatment before enrollment in this study;
- no evidence of hepatitis B or C virus infection.
Exclusion criteria:
- prior monoclonal antibody therapy other than rituximab, anti-cancer vaccine, or radioimmunotherapy for cancer;
- history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products;
- major surgery, other than for diagnosis, within 4 weeks of screening.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: April, 2005
Trial registration date: 07/26/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Canada
France
- Creteil
- Lille
- Nantes
- Pierre Benite
- Rennes
Italy
Sweden
Switzerland
