Tisagenlecleucel for Follicular Lymphoma

(ELARA Trial)

Recruiting at 45 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must not be taking: Anti-CD19, Gene therapy

Disqualifiers: Histologic transformation, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

98 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment tisagenlecleucel for follicular lymphoma?

Research shows that tisagenlecleucel is effective for patients with relapsed or refractory follicular lymphoma, with a high complete response rate of about 69% in a clinical trial. This means that a significant number of patients experienced a full disappearance of their cancer symptoms after treatment. ^{1 2 3 4 5}

How is the treatment tisagenlecleucel unique for follicular lymphoma?

Tisagenlecleucel is a unique treatment for follicular lymphoma because it is a CAR-T cell therapy, which means it uses modified immune cells to target and destroy cancer cells. This approach is different from traditional chemotherapy or radiation, as it specifically targets the CD19 protein on cancer cells, offering a new option for patients who have not responded to other treatments. ^{1 2 4 5 6}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with Follicular Lymphoma grades 1, 2, or 3A that hasn't responded to treatment or has come back. Participants must have measurable disease. Those with transformed lymphoma, brain involvement by cancer, previous stem cell transplant, grade 3B lymphoma, or prior gene or anti-CD19 therapy can't join.

Inclusion Criteria

Radiographically measurable disease at screening

My Follicular Lymphoma has returned or is not responding to treatment.

Exclusion Criteria

I have had a stem cell transplant from a donor.

I have had adoptive T cell therapy before.

I have received gene therapy before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants may undergo optional bridging therapy and lymphodepleting chemotherapy

2-4 weeks

Treatment

Participants receive tisagenlecleucel infusion

1 day

Follow-up

Participants are monitored for safety and efficacy, including survival follow-up every 3 months

24 months

Treatment Details

Interventions

• tisagenlecleucel

Trial Overview The study tests the effectiveness and safety of a drug called tisagenlecleucel in treating Follicular Lymphoma that's either stopped responding to standard treatments or has returned after treatment.

Participant Groups

Group I: CTL019 Experimental Treatment 1 Intervention

All patients who received tisagenlecleucel infusion.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

Tisagenlecleucel has been found to be both safe and effective for adults suffering from relapsed or refractory follicular lymphoma, indicating its potential as a treatment option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tisagenlecleucel Is Safe and Effective in Relapsed/Refractory Follicular Lymphoma. [2022]

In a phase 3 trial with 322 patients suffering from aggressive B-cell non-Hodgkin's lymphoma, tisagenlecleucel did not show superior efficacy compared to standard salvage chemotherapy and autologous stem-cell transplantation, with both groups having a median event-free survival of 3.0 months.

Response rates were similar between the two groups, with 46.3% of patients receiving tisagenlecleucel responding compared to 42.5% in the standard-care group, indicating that while tisagenlecleucel is a treatment option, it may not provide additional benefits over existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma. Bishop, MR., Dickinson, M., Purtill, D., et al.[2022]

In the ELARA phase 2 trial involving 98 patients with relapsed/refractory follicular lymphoma, tisagenlecleucel demonstrated a complete response rate of 69.1% and an overall response rate of 86.2%, indicating its efficacy in this patient population.

The treatment was found to be safe, with manageable side effects; 48.5% of patients experienced cytokine release syndrome, but there were no treatment-related deaths, highlighting its safety profile even in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Fowler, NH., Dickinson, M., Dreyling, M., et al.[2022]

Tisagenlecleucel (tisa-cel) is an effective CAR-T therapy for patients with relapsed/refractory follicular lymphoma (R/R FL), showing durable remissions even in high-risk patients, as confirmed by the pivotal ELARA study.

The therapy has a manageable toxicity profile, making it a viable option for patients who have undergone two lines of systemic therapies, leading to its FDA approval for this indication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tisagenlecleucel: CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma. Saha, A., Jhaveri, K., Sarfraz, H., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tisagenlecleucel Is Safe and Effective in Relapsed/Refractory Follicular Lymphoma. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tisagenlecleucel in adult Japanese patients with relapsed or refractory follicular lymphoma: results from the phase 2 ELARA trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Real-world evidence of tisagenlecleucel for pediatric acute lymphoblastic leukemia and non-Hodgkin lymphoma. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Tisagenlecleucel: CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma. [2023]