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CAR T-cell Therapy

Tisagenlecleucel for Follicular Lymphoma (LEDA Trial)

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF

Follicular lymphoma grade 3B or evidence of histologic transformation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

"This trial will compare a new treatment called tisagenlecleucel to the usual treatment in adults with a type of lymphoma that has relapsed or not responded to previous treatments."

Who is the study for?

Adults over 18 with relapsed or refractory follicular lymphoma, who have tried at least two systemic therapies including an anti-CD20 antibody and an alkylating agent. They must show active disease on PET and CT scans, be in fair health (ECOG 0-2), and have good organ function to participate.

What is being tested?

The trial is testing Tisagenlecleucel against the standard of care treatments for follicular lymphoma. Standard care includes a combination of chemotherapy drugs (R-CHOP) or Lenalidomide plus Rituximab (R2). Participants will receive one treatment based on random assignment.

What are the potential side effects?

Tisagenlecleucel may cause immune system reactions, infusion-related symptoms, low blood cell counts leading to infection risk, fatigue, and breathing difficulties. Chemotherapy can lead to nausea, hair loss, mouth sores, increased infection risk and potential damage to organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My disease shows active on PET scan and is measurable on CT scan.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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My follicular lymphoma is confirmed as grade 1, 2, or 3A after the latest relapse.

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My condition did not improve after treatments including an anti-CD20 antibody and an alkylating agent.

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I am eligible for a leukapheresis procedure according to my hospital's rules.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart conditions like heart failure or abnormal heart rhythms.

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My lymphoma is either grade 3B or has changed in its appearance under the microscope.

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I have previously received treatments like anti-CD19, gene, or T-cell therapy.

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My cancer has spread to my brain or spinal cord.

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I do not have an active infection, HIV, or active hepatitis B or C.

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I do not have active neurological disorders like Guillain-Barré syndrome.

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I haven't taken any experimental drugs in the last 30 days or longer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Anti-mCAR, T cell response, as measured by IFNγ expression (cellular immunogenicity)

CAR transgene levels, as measured by quantitative polymerase chain reaction (qPCR), in peripheral blood, bone marrow (and other tissues, if available)

Complete response rate (CRR) as assessed by BIRC (Key Secondary)

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TisagenlecleucelExperimental Treatment3 Interventions

Participants randomized to the tisagenlecleucel treatment strategy will receive a single infusion of 0.6 to 6 x 10\^8 CAR-positive viable T-cells

Group II: R2 or R-CHOPActive Control2 Interventions

Participants randomized to Standard of Care treatment will receive either R2 or R-CHOP based on investigator choice of therapies, and this has to be determined prior to randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lymphodepleting chemotherapy

2014

Completed Phase 2

~130

Tisagenlecleucel

2019

Completed Phase 2

~370