Efficacy and safety of tisagenlecleucel in adult patients with refractory or relapsed follicular lymphoma
Phase 2
Completed
- Conditions
- Follicular Lymphoma
- Registration Number
- jRCT1080224541
- Lead Sponsor
- Novartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A) Radiographically measurable disease at screening
Exclusion Criteria
Evidence of histologic transformation Follicular Lymphoma Grade 3B Prior anti-CD19 therapy Prior gene therapy Prior adoptive T cell therapy Prior allogeneic hematopoietic stem cell transplant Active CNS involvement by malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Phase II, single-arm, multi-center, open-label study for r/r FL patients
- Primary Outcome Measures
Name Time Method - efficacy
CRR (Complete response rate)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan/Asia except Japan/North America/South America/Europe/Oceania
Location not specified
Japan/Asia except Japan/North America/South America/Europe/Oceania