Clinical Trial: NCT03570892
Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2026-06-12 |
Study Overview
Brief Summary
This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.
Official Title
Tisagenlecleucel Versus Standard of Care in Adult Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma: A Randomized, Open Label, Phase III Trial (BELINDA)
Conditions
Non-Hodgkin Lymphoma
Intervention / Treatment
- Drug: Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy
- Drug: Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)
Other Study ID Numbers
- CCTL019H2301
- 2016-002966-29
- 2023-508343-48-00
- 2023
- 2016
Start Date (Actual)
2019-05-09
Primary Completion Date (Actual)
2021-05-06
Study Completion Date (Actual)
2026-02-03
Enrollment (Actual)
330
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2026-06-12 |
Study Overview
Brief Summary
This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.
Official Title
Tisagenlecleucel Versus Standard of Care in Adult Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma: A Randomized, Open Label, Phase III Trial (BELINDA)
Conditions
Non-Hodgkin Lymphoma
Intervention / Treatment
- Drug: Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy
- Drug: Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)
Other Study ID Numbers
- CCTL019H2301
- 2016-002966-29
- 2023-508343-48-00
- 2023
- 2016
Start Date (Actual)
2019-05-09
Primary Completion Date (Actual)
2021-05-06
Study Completion Date (Actual)
2026-02-03
Enrollment (Actual)
330
Study Type
Interventional
Phase
Phase 3