Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UCLA UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Charalambos Andreadis (ucsf)

Description

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)

Details

Approximately 318 subjects were planned to be randomized; 322 subjects were analyzed (Full analysis set): 162 subjects in the tisagenlecleucel arm and 160 subjects in the SOC arm.

The target population consisted of adult participants with aggressive B-cell non-Hodgkin lymphoma (NHL) who were relapsed/refractory within 365 days of their last dose of first line immunochemotherapy and eligible for autologous hematopoietic stem cell transplantation (HSCT).

The duration of treatment in the tisagenlecleucel treatment strategy is from the start of bridging chemotherapy (if applicable) until the infusion of tisagenlecleucel (expected on average at approximately 6 weeks from randomization). The duration of the treatment in the SOC treatment strategy is from the start of salvage chemotherapy until autologous HSCT. In either treatment arm, if infusion of tisagenlecleucel or autologous HSCT is not possible, the duration of treatment is until the last dose of study treatment prior to discontinuation of the treatment strategy.

Keywords

Non-Hodgkin Lymphoma, Non-Hodgkin's Lympoma, B-Cell Lymphoma, Diffuse Large B-cell Lymphoma, High Grade B-cell Lymphoma, Follicular Lymphoma grade 3B, CAR-T, Tisagenlecleucel, Kymriah, Immunotherapy, Cellular therapy, CTL019, Lymphoma, Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy, Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)

Eligibility

Locations

  • Moores UC San Diego Cancer Center
    La Jolla California 92093 United States
  • University of California Los Angeles
    Los Angeles California 90095 United States
  • UCSF Medical Center
    San Francisco California 94143 United States

Lead Scientist at University of California Health

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
Links
Related Info
ID
NCT03570892
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 331 people participating
Last Updated