For US residents only.

Non-Hodgkin Lymphoma (BELINDA)

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).

Overview

This Study Is Recruiting: Phase III Actual Start Date: [May 6, 2019] Estimated Completion Date: [October 3, 2025] Novartis Reference Number: CCTL019H2301
Condition: Non-Hodgkin Lymphoma (NHL) Interventions: Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy, Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and HSCT Estimated Enrollment: [318 participants] ClinicalTrials.gov Identifier: NCT03570892
This Study Is Recruiting: Phase III Actual Start Date: [May 6, 2019]
Estimated Completion Date: [October 3, 2025] Novartis Reference Number: CCTL019H2301
Condition: Non-Hodgkin Lymphoma (NHL) Interventions: Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy, Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and HSCT
Estimated Enrollment: [318 participants] ClinicalTrials.gov Identifier: NCT03570892

Study Goal

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.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

Participants may be eligible to participate if they:

  • Are ≥ 18 years of age
  • Have histologically confirmed, aggressive B-cell non-Hodgkin lymphoma at relapse/progression after frontline therapy
  • Have relapsed or progressed within 1 year from the last dose of rituximab and anthracycline-containing first-line immunotherapy, or are refractory (not achieved CR or PR)
  • Are eligible for autologous stem cell transplant (ASCT)
  • Meet other eligibility criteria

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

Find a Trial Site Location

To find a list of all our recruiting site locations, enter your address below.

×
0 results listed in order of distance from

Still Have a Question?

Are you a Patient or Caregiver looking for more information?

Are you a Health Care Professional looking for more information?

To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.

Other non-Hodgkin lymphoma trials you might be interested in:

A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Safety and Efficacy of Tisagenlecleucel in Pediatric Subjects With Relapsed or Refractory Mature B-Cell Non-Hodgkin Lymphoma (B-Cell NHL).

Definitions:
ASCT - autologous stem cell transplant, CR - complete response, HSCT - hematopoietic stem cell transplant, ICF - informed consent form, PR - partial response

Last Updated: July 17, 2019

8/19 M-GON-1216060