Recruitment Status:
Completed
Project Status:
Completed
Project Description:
This is a randomized, Phase IIIb, open-label, multi-centre study designed to evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or the intravenous (IV) route or rituximab administration in previously untr . . .
Primary Sponsor:
Roche (Philippines), Inc.
Study Type:
Interventional
Date of Registration:
12 August 2013
Date of FIrst Enrollment:
12 August 2013
Method of Allocation:
Randomized
FDA Clinical Trial Reference (CTR) Number:
2012-CT0083
Sources of Monetary or Material Support:
Roche (Philippines), Inc.
Primary Outcomes:
To evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or the intravenous (IV) route of rituximab administration.
Key Inclusion and Exclusion Criteria:
Inclusion Criteria Patients must meet the following criteria for study entry (i.e. prior to randomization): 1. Signed, written informed consent form 2. Age ≥ 18 and ≤ 80 years 3. Histologically confirmed, previously untreated CD20+ DLBCL or CD20+ follicular NHL Grade 1, 2 or 3a, according to the . . .
Countries of Recruitment:
Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey
Health Condition(s) or Problem(s) Studied:
CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin’s Lymphoma Grades 1, 2 or 3A