Diffuse Large B-cell Lymphoma (DLBCL)
Conditions
Interventions
Biological: Tisagenlecleucel
Drug: Lymphodepleting chemotherapy
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent must be obtained prior to any screening procedures - Relapsed or refractory disease after >=2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT - Measurable disease at time of enrollment - Life expectancy >=12 weeks - Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening - Adequate organ function - Adequate bone marrow reserve without transfusions - Must have an apheresis product of non-mobilized cells accepted for manufacturing Other protocol-related inclusion may apply.
Exclusion criteria
Exclusion criteria: - Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy - Treatment with any prior gene therapy product - Active Central Nervous System (CNS) involvement by malignancy - Prior allogeneic HSCT - Eligible for and consenting to HSCT - Active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive ) - HIV positive patients - Pregnant or nursing (lactating) women Other protocol-related exclusion may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) [ Time Frame: 5 years ] | — |
Countries
Australia, Austria, Canada, France, Germany, Italy, Netherlands, Norway, United States
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed