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Chemotherapy
Tisagenlecleucel for B-Cell Lymphoma (BELINDA Trial)
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ function: Renal function defined as: Serum creatinine of ≤1.5 x upper limit of normal (ULN), OR estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 Hepatic function defined as: Alanine Transaminase (ALT) and Aspartate Transiminase (AST) ≤ 5 × ULN Total bilirubin ≤ 1.5 x ULN with the exception of patients with Gilbert syndrome who may be included if their total bilirubin is ≤3.0 × ULN and direct bilirubin ≤1.5 × ULN Hematologic Function (regardless of transfusions) defined as: Absolute neutrophil count (ANC) >1000/mm3 Absolute lymphocyte count (ALC) >300/mm3 OR Absolute number of CD3+ T cells >150/mm3 (only for patients with non-historical apheresis) Platelets ≥50000/mm3 Hemoglobin >8.0 g/dl Adequate pulmonary function defined as: No or mild dyspnea (≤ Grade 1) Oxygen saturation measured by pulse oximetry > 90% on room air Forced expiratory volume in 1 s (FEV1) ≥ 50% and/or carbon monoxide diffusion test (DLCO) ≥50% of predicted level Must have a leukapheresis material of non-mobilized cells available for manufacturing.
Histologically confirmed, aggressive B-cell NHL at relapse/progression or PR after front line therapy. Aggressive B-cell NHL is heretofore defined by the following list of subtypes (Swerdlow et al 2016): DLBCL, NOS, FL grade 3B, Primary mediastinal large B cell lymphoma (PMBCL), T cell rich/histiocyte rich large B cell lymphoma (T/HRBCL), DLBCL associated with chronic inflammation, Intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, B-cell lymphoma, unclassifiable, (with features intermediate between DLBCL and classical Hodgkin's Lymphoma (HL)), High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, High-grade B-cell lymphoma, NOS HHV8+ DLBCL, NOS DLBCL transforming from follicular lymphoma DLBCL transforming from marginal zone lymphoma DLBCL, leg type Relapse or progression within 365 days from last dose of anti CD20 antibody and anthracycline containing first line immunochemotherapy or refractory (have not achieved a CR). Patient is considered eligible for autologous HSCT as per local investigator assessment. Note: Intention to transplant and type of high dose chemotherapy (HDCT) regimen will be documented at the time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
BELINDA Trial Summary
This trial is testing whether a new treatment, tisagenlecleucel, is better than the current standard of care for aggressive B-cell Non-Hodgkin Lymphoma that has not responded to other treatments.
Who is the study for?
This trial is for adults with aggressive B-cell Non-Hodgkin Lymphoma who didn't respond well to initial treatments including rituximab and anthracycline. Participants need good organ function, no severe heart issues, and must not have had certain previous therapies like anti-CD19 therapy or allogeneic HSCT. They should be physically able to undergo the procedures involved.Check my eligibility
What is being tested?
The study compares tisagenlecleucel (a type of immunotherapy) after optional chemotherapy to standard platinum-based immunochemotherapy followed by high dose chemo and stem cell transplant in patients responding to treatment. It's a phase III trial, meaning it's testing effectiveness on a larger scale.See study design
What are the potential side effects?
Tisagenlecleucel can cause immune system reactions, difficulty breathing, fever, fatigue, and may affect blood cells leading to increased infection risk. Chemotherapy might result in nausea, hair loss, mouth sores, low blood counts increasing infection risk.
BELINDA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My aggressive B-cell NHL has returned or worsened after initial treatment.
Select...
My disease shows active on PET and measurable on CT scans, and I'm mostly self-sufficient.
BELINDA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival (EFS)
Secondary outcome measures
Duration of Response (DOR)
EFS as assessed by local investigator
EQ-VAS
+8 moreBELINDA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tisagenlecleucel treatment strategyExperimental Treatment1 Intervention
Patients will receive investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel
Group II: Standard of care treatment strategyActive Control1 Intervention
Patients will receive investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,019 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have already received treatment with certain types of therapies or gene therapy products. You have received second-line anticancer therapy before being enrolled in this trial, except for steroids and local irradiation. You have active disease in your central nervous system, unless it has been effectively treated and local treatment was over 4 weeks ago. You have undergone allogeneic HSCT or have a significant active infection.My aggressive B-cell NHL has returned or worsened after initial treatment.My disease shows active on PET and measurable on CT scans, and I'm mostly self-sufficient.You have certain heart conditions such as recent heart attack, heart failure, or abnormal heart rhythms. Your heart's pumping ability is also below a certain level. You have a high risk for a dangerous heart rhythm disorder called Torsades de Pointes or have a history of long QT syndrome or sudden death in the family. You also have active neurological or cerebrovascular disorders.There may be other requirements that you need to meet or avoid to be eligible for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Tisagenlecleucel treatment strategy
- Group 2: Standard of care treatment strategy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Tisagenlecleucel received FDA approval when used in combination with other treatments?
"Tisagenlecleucel, which is sometimes used in conjunction with other chemotherapy drugs and can be given after lymphodepleting chemotherapy, has been rated a 3 for safety."
Answered by AI
Are we currently looking for more participants in this trial?
"The information on clinicaltrials.gov suggests that this trial is not currently enrolling patients. The study was first posted on May 7th, 2019 and updated for the last time on October 31st, 2022. There are 2,017 other trials which are actively recruiting patients right now."
Answered by AI
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