A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination with Rituximab for Subjects with Relapsed, Follicular Non Hodgkin's Lymphoma who Previously Responded on Study 114-NH-301 - 114-NH-302
Active, not recruiting
- Conditions
- on Hodgking LynphomaMedDRA version: 9.1Level: LLTClassification code 10029609Term: Non-Hodgkin's lymphoma unspecified histology aggressive recurrent
- Registration Number
- EUCTR2006-003987-74-IT
- Lead Sponsor
- BIOGEN IDEC LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 345
Inclusion Criteria
ICF signature Responsiveness in study 114-NH-301, relapsed or progression with TTP higher than 6 months Bidimensionally measurable pathology
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Under lymphoma therapy between final visit of 114-NH-301 and 1st retreatment day
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method