CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 330 enrolled / 330 target
Drug / intervention
Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03570892
NCT03570892Phase 3CompletedMonitor (3.9/mo)Completion was 61mo ago
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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)

Novartis Pharmaceuticals·interventional·Posted Jun 27, 2018·Updated Jun 12, 2026

In Brief

A Phase 3 clinical trial evaluating Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy and Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT) for Non-Hodgkin Lymphoma. Completed, enrolled 330 participants across 67 sites in 18 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin Lymphoma
CountriesAustralia, Austria, Belgium, Brazil, China, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 27, 2018
Enrollment StartMay 9, 2019
Primary CompletionMay 6, 2021
Study CompletionFeb 3, 2026
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.0 years ago

Arms & Interventions

Tisagenlecleucel treatment strategyexperimental

Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel

Drug: Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy
Standard of care treatment strategyactive_comparator

Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)

Drug: Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)

Interventions

Tisagenlecleucel after optional bridging and lymphodepleting chemotherapydrug

Investigator's choice of optional platinum-based immunochemotherapy (ie. R-ICE, R-GemOx, R-GDP, R-DHAP) + Lymphodepleting chemotherapy (fludarabine with cyclophosphamide or bendamustine) + Tisagenlecleucel (a second generation CAR-T composed of a CD19 antigen-binding domain, a 4-1BB costimulatory domain and a CD3-ζ signaling domain)

Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)drug

Investigator's choice of platinum-based immunochemotherapy (ie. R-ICE, R-GemOx, R-GDP, R-DHAP)+ High dose chemotherapy (ie. BEAM) + autologous HSCT. \*Ibrutinib or lenalidomide may be used in patients who are no longer eligible for autologous HSCT after 2 cycles of immunochemotherapy