BridgeMD
A randomized, open-label, multi-center phase III trial comparing tisagenlecleucel to standard of care in adult participants with relapsed or refractory follicular lymphoma
EU CTIS ID: 2023-503452-27-00
What this study is testing
To demonstrate superiority of the tisagenlecleucel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by blinded independent review committee (BIRC) based on the Lugano response criteria
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1.Age ≥ 18 years at the date of signing the informed consent form.
- 2.Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
- 3.Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
- 4.Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan.
- 5.ECOG performance status of 0, 1 or 2 at screening.
- 6.Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
You likely can't join if
- 1.Follicular lymphoma grade 3B or evidence of histologic transformation.
- 2.Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
- 3.Active CNS involvement by malignancy.
- 4.Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
- 5.Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
- 6.Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
See the full eligibility criteria
- 1.Age ≥ 18 years at the date of signing the informed consent form.
- 2.Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
- 3.Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
- 4.Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan.
- 5.ECOG performance status of 0, 1 or 2 at screening.
- 6.Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
- 7.Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
- 8.Must be eligible for treatment with the selected standard of care regimen.
- 1.Follicular lymphoma grade 3B or evidence of histologic transformation.
- 2.Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
- 3.Active CNS involvement by malignancy.
- 4.Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
- 5.Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
- 6.Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
- 7.Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Taiwan
- Singapore
- Canada
- Australia
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Taiwan; Singapore; Canada; Australia; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.