230 Participants Needed

Axicabtagene Ciloleucel for Follicular Lymphoma

(ZUMA-22 Trial)

Recruiting at 51 trial locations
MI
Overseen ByMedical Information
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

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.

Is Axicabtagene Ciloleucel (Yescarta) safe for humans?

Axicabtagene ciloleucel (Yescarta) has been used in various studies for different types of lymphoma, showing a manageable safety profile. Common side effects include cytokine release syndrome (a reaction that can cause fever and low blood pressure), neurological issues, infections, fever, diarrhea, nausea, low blood pressure, and fatigue.12345

How is the treatment axicabtagene ciloleucel unique for follicular lymphoma?

Axicabtagene ciloleucel is a unique treatment for follicular lymphoma because it is a CAR-T cell therapy, which uses the patient's own modified immune cells to target and destroy cancer cells, offering high response rates and durable remissions even in patients with difficult-to-treat cases.12467

What data supports the effectiveness of the treatment Axicabtagene Ciloleucel for Follicular Lymphoma?

Research shows that Axicabtagene Ciloleucel (axi-cel) is effective for patients with relapsed or refractory follicular lymphoma, with high response rates and durable remissions observed in the ZUMA-5 study. It is considered a promising option for patients who have not responded to other treatments.12468

Who Is on the Research Team?

KS

Kite Study Director

Principal Investigator

Kite, A Gilead Company

Are You a Good Fit for This Trial?

This trial is for adults with a confirmed diagnosis of follicular lymphoma who need treatment and have at least one measurable lesion. They must have had the disease return or not respond after initial therapy, including those whose disease came back within 24 months or after two treatments. Pregnant women, individuals with certain nervous system disorders, severe neuropathy, active infections (including HIV and hepatitis), autoimmune diseases, cardiac issues in the past six months, prior CD19-targeted therapies or CAR T-cell therapies cannot participate.

Inclusion Criteria

My cancer returned or didn't respond after initial treatment and it's considered high-risk.
At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
I need treatment for my condition.
See 2 more

Exclusion Criteria

History of autoimmune disease
I have been diagnosed with small lymphocytic lymphoma.
I have severe nerve pain or numbness.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either axicabtagene ciloleucel or standard of care therapy, including Rituximab-based regimens

6-12 cycles (21-28 days per cycle)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Long-term Follow-up

Participants who received axicabtagene ciloleucel transition to a separate study for continued monitoring

Remainder of 15 years

What Are the Treatments Tested in This Trial?

Interventions

  • Axicabtagene Ciloleucel
Trial Overview The study is testing axicabtagene ciloleucel against standard care drugs like Vincristine, Prednisone, Bendamustine etc., to see which works better for relapsed/refractory follicular lymphoma. Participants will be randomly assigned to receive either the study drug or one of the standard care options.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Axicabtagene CiloleucelExperimental Treatment3 Interventions
Group II: Standard of Care TherapyActive Control7 Interventions

Axicabtagene Ciloleucel is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Yescarta for:
🇪🇺
Approved in European Union as Yescarta for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kite, A Gilead Company

Lead Sponsor

Trials
45
Recruited
4,300+

Published Research Related to This Trial

Axicabtagene ciloleucel (Yescarta) is an approved second-line treatment for patients with large B-cell lymphoma who do not respond to or relapse within 12 months of initial chemoimmunotherapy.
Patient identity confirmation and premedication to reduce hypersensitivity reactions are essential steps in the administration of this autologous infusion therapy.
New Second-Line Treatment for B-Cell Lymphoma.Aschenbrenner, DS.[2022]
The interim analysis of the phase 2 ZUMA-5 study showed that axicabtagene ciloleucel (axicel; Yescarta) provided significant and durable clinical benefits for patients with relapsed or refractory indolent non-Hodgkin lymphoma, indicating its efficacy in this patient population.
The treatment demonstrated a high overall response rate (ORR) and complete response (CR) rate, while maintaining a manageable safety profile, suggesting it is a viable option for patients with this type of lymphoma.
Interim Phase 2 ZUMA-5 Results Show Promise for Axi-Cel in R/R iNHL.Slater, H.[2021]
In a study of 122 patients treated with axicabtagene ciloleucel (axi-cel) for relapsed aggressive B-cell non-Hodgkin lymphoma, the overall response rate was 70% and the complete response rate was 50%, indicating strong efficacy even in a post-commercial setting with relaxed eligibility criteria.
Patients eligible for the original ZUMA-1 trial had significantly better outcomes, including higher complete response rates (63% vs. 42%) and longer duration of response, progression-free survival, and overall survival, while the rates of severe side effects like cytokine release syndrome and neurotoxicity were consistent with those observed in clinical trials.
Axicabtagene Ciloleucel in the Non-Trial Setting: Outcomes and Correlates of Response, Resistance, and Toxicity.Jacobson, CA., Hunter, BD., Redd, R., et al.[2022]

Citations

New Second-Line Treatment for B-Cell Lymphoma. [2022]
Interim Phase 2 ZUMA-5 Results Show Promise for Axi-Cel in R/R iNHL. [2021]
Axicabtagene Ciloleucel in the Non-Trial Setting: Outcomes and Correlates of Response, Resistance, and Toxicity. [2022]
Axicabtagene Ciloleucel in the Management of Follicular Lymphoma: Current Perspectives on Clinical Utility, Patient Selection and Reported Outcomes. [2023]
Axicabtagene Ciloleucel: Clinical Data for the Use of CAR T-cell Therapy in Relapsed and Refractory Large B-cell Lymphoma. [2021]
Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium. [2022]
EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell Lymphoma. [2022]
Axicabtagene ciloleucel for the treatment of relapsed or refractory follicular lymphoma. [2022]
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