Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
Phase 3
Completed
- Conditions
- indolent B-cell NH
- Registration Number
- JPRN-jRCT2080221922
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 346
Inclusion Criteria
Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
Exclusion Criteria
Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Overall Response Rate, Overall Survival