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RecruitingPHASE3INTERVENTIONAL

Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

This research study is looking at two advanced treatments, KITE-753 and axicabtagene ciloleucel, for adults living with a specific type of blood cancer called large B-cell lymphoma. This study is specifically for individuals whose cancer has either returned after their initial treatment (relapsed) or hasn't fully responded to it (refractory). The main goal is to compare how effective KITE-753 is against axicabtagene ciloleucel. Both treatments are designed to help fight the cancer when standard first-line therapies haven't been enough. By comparing them, doctors hope to understand which option might be better for future patients.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Kite, A Gilead Company
Enrolment target
550
Start
22 May 2026
Estimated completion
01 May 2031

What is this study about?

This research study, called a Phase 3 clinical trial, is focusing on a type of blood cancer known as large B-cell lymphoma. This is when certain white blood cells (B-cells) grow out of control. For many patients, the first treatments they receive work well. However, for some, the cancer either doesn't fully go away or comes back after a while.

This study is for adults whose large B-cell lymphoma has either relapsed (come back) or is refractory (hasn't responded well) after their first course of treatment. The main purpose is to compare two advanced treatments: KITE-753 and axicabtagene ciloleucel (sometimes called axi-cel). Both of these are investigational treatments designed to target cancer cells. Researchers want to see which one is more effective at treating the lymphoma in this situation.

By carefully comparing these two treatments, doctors hope to find out which one offers a better chance of helping patients whose cancer has been particularly difficult to treat. This kind of research is vital for developing new and improved ways to fight cancer in the future.

Key takeaways

  • This study compares two new treatments for a type of blood cancer (large B-cell lymphoma).
  • It's for adults whose cancer has returned or didn't respond to their first treatment.
  • The main goal is to see which treatment works better.
  • Participants will receive either KITE-753 or axicabtagene ciloleucel.
  • Taking part involves regular check-ups and close monitoring by doctors.
  • You have the right to leave the study at any time.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) with large B-cell lymphoma. This study is specifically for people whose cancer either hasn't responded well to their first treatment, or has come back after their first treatment, within 12 months. Your previous treatment must have included a specific type of antibody therapy (anti-CD20) and a chemotherapy drug called an anthracycline.

Your doctor will need to confirm that you have measurable signs of the lymphoma. This means there's a way to track the cancer's size and how it responds to treatment. There are also specific rules about how much time must have passed since your last treatment and if you've had any other treatments since your first main one. If you have another type of lymphoma that has changed into large B-cell lymphoma, the treatments you had for the original lymphoma might not count towards the eligibility.

It's important to know that these are just some of the main rules. There are other detailed criteria your doctor will check to make sure the study is right for you and safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have large B-cell lymphoma?
  3. Has your lymphoma come back or not responded well to your first treatment?
  4. Did your first treatment include specific antibody and chemotherapy drugs?
  5. Do doctors currently have a way to measure your cancer (e.g., on a scan)?
Answer every question to see your result.

What does participation involve?

The detailed plan for taking part in this study would be explained by your study doctor. It would involve regular visits to the hospital or clinic for check-ups, tests, and to receive your assigned treatment (either KITE-753 or axicabtagene ciloleucel). You would also receive some chemotherapy drugs (Fludarabine and Cyclophosphamide) before the main treatment.

These visits might include blood tests, scans (like CT scans), and physical examinations to see how you are responding to the treatment and to monitor your general health. You would be closely monitored, especially after receiving the main treatment, to manage any side effects. The total duration of your participation, including follow-up, would be fully explained before you agree to join.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might gain access to a new treatment before it's widely available, and your health will be very closely monitored by a dedicated medical team. Your participation could also help others in the future by improving understanding of large B-cell lymphoma treatments. However, there's no guarantee the treatment will work for you, and there could be side effects, some of which may be serious. The research team will explain all known side effects and potential risks in detail. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (19)

  • City of Hope Arizona
    Verified postcode
    Goodyear, United States· Recruiting
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    Verified postcode
    Duarte, United States· Recruiting
  • Stanford University
    Verified postcode
    Stanford, United States· Recruiting
  • Colorado Blood Cancer Institute
    Verified postcode
    Denver, United States· Recruiting
  • Yale University School of Medicine
    Verified postcode
    New Haven, United States· Recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Recruiting
  • Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
    Verified postcode
    Newnan, United States· Recruiting
  • City of Hope - Chicago
    Verified postcode
    Zion, United States· Recruiting
  • Washington University
    Verified postcode
    St Louis, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • Novant Health Cancer Institute - Hematology
    Verified postcode
    Charlotte, United States· Recruiting
  • Henry-Joyce Cancer Clinic
    Verified postcode
    Nashville, United States· Recruiting

Common questions

What is large B-cell lymphoma?

It's a type of cancer that starts in white blood cells called B-cells. These cells usually help fight infections, but in lymphoma, they grow abnormally.

What does 'relapsed or refractory' mean?

'Relapsed' means your cancer came back after treatment. 'Refractory' means your cancer didn't respond well or stopped responding to your first treatment.

What kind of treatments are KITE-753 and axicabtagene ciloleucel?

These are investigational treatments that are designed to target and fight cancer cells. They are not standard first-line treatments.

Will I definitely get one of these new treatments?

Yes, if you join this study, you will receive either KITE-753 or axicabtagene ciloleucel. Which one you get is decided by chance, like flipping a coin.

Is this study safe?

All clinical trials have potential risks and benefits. Your safety will be closely monitored by a team of doctors and nurses, and all risks will be explained to you.

How to find out more

Medical Information

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study Evaluating the Efficacy of KITE-753 Versus Axicabtagen…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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