Active — Not RecruitingPhase 3

A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

Australia, Austria109 participantsStarted 2023-10-02

Plain-language summary

This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years at the date of signing the informed consent form.
✓. Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
✓. Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
✓. 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.
✓. ECOG performance status of 0, 1 or 2 at screening.
✓. Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
✓. Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
✓. Must be eligible for treatment with the selected standard of care regimen.

✕. Follicular lymphoma grade 3B or evidence of histologic transformation.
✕. Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
✕. Active CNS involvement by malignancy.
✕. Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
✕. Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
✕. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
✕. Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.

Progression-free survival (PFS) determined by blinded independent review committee (BIRC)

Timeframe: 5 years

NCT IDNCT05888493

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07-25

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years at the date of signing the informed consent form.
✓. Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
✓. Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
✓. 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.
✓. ECOG performance status of 0, 1 or 2 at screening.
✓. Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
✓. Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
✓. Must be eligible for treatment with the selected standard of care regimen.

✕. Follicular lymphoma grade 3B or evidence of histologic transformation.
✕. Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
✕. Active CNS involvement by malignancy.
✕. Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
✕. Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
✕. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
✕. Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.