A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA 25) – Substudy C – Relapsed/Refractory Burkitt Lymphoma (BL)
This study, called ZUMA-25 (Substudy C), is investigating a new treatment called Tecartus for adult patients in the UK who have Burkitt Lymphoma. This is a type of blood cancer, and the study is specifically for those whose cancer has returned after initial treatment or hasn't responded well to previous therapies. Researchers want to see if Tecartus can make the cancer shrink or disappear, which they call a 'response'. They will also look at how long any response lasts, how long people live, and how long they live without the cancer getting worse. This is a Phase 2 study, meaning it's still in the earlier stages of testing the treatment's effectiveness and safety, building on previous research.
At a glance
What is this study about?
This study is investigating a new treatment called Tecartus for adults in the UK who have a type of cancer called Burkitt Lymphoma. Burkitt Lymphoma is a fast-growing cancer that affects white blood cells called B-cells. This particular study is for people whose cancer has come back after being treated before (called 'relapsed') or hasn't responded to previous treatments (called 'refractory'). It's important to find new options because current treatments don't always work for everyone, especially when the cancer returns.
The main goal of this study is to see how many patients respond positively to the Tecartus treatment. A 'response' means the cancer either shrinks significantly or completely disappears. Researchers will carefully monitor patients to see if they achieve this. They will also look at how long any positive response lasts, how long patients live overall, and how long they live without the cancer getting worse.
Tecartus is a type of treatment called CAR T-cell therapy. This involves taking some of a patient's own immune cells, modifying them in a lab so they are better at finding and killing cancer cells, and then giving them back to the patient. This study is in 'Phase 2', meaning it's aimed at finding out more about how well the treatment works and further evaluating its safety, after initial safety tests have been done. There are other existing treatments listed that may also be used alongside or before Tecartus in certain situations.
Key takeaways
- This study is for adults with Burkitt Lymphoma whose cancer has relapsed or is refractory.
- It's testing a new treatment called Tecartus (CAR T-cell therapy).
- The main aim is to see how many patients respond to the treatment.
- Participants may receive other cancer medicines alongside Tecartus.
- Potential benefits include a new treatment option; potential risks include side effects.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. The study is open to both men and women.
The main condition for joining is that you must have Burkitt Lymphoma, and your cancer must have either come back after previous treatment (relapsed) or not responded well to past treatments (refractory). This means the study is focused on people who have limited other treatment options.
There will be other specific medical checks to make sure the treatment is suitable and safe for you. These will be explained by the study doctor, as people with certain other health conditions might not be able to participate.
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.
- Are you 18 years old or older?
- Have you been diagnosed with Burkitt Lymphoma?
- Has your Burkitt Lymphoma come back after treatment or not responded to previous treatments?
- Are you able to attend regular hospital appointments?
What does participation involve?
If you decide to take part in this study, you would receive the new treatment called Tecartus. Before receiving Tecartus, you might have some other chemotherapy treatments like gemcitabine, vincristine, doxorubicin, fludarabine, cyclophosphamide, carboplatin, ifosfamide, or etoposide. These are medicines commonly used in cancer treatment, and their purpose here might be to prepare your body for the Tecartus.
Throughout the study, you would have regular visits to the hospital or clinic. These visits would involve doctors checking your health, taking blood samples, and performing scans to see how the treatment is affecting your Burkitt Lymphoma. You might also receive steroid medications like dexamethasone, methylprednisolone, or prednisolone, and other drugs like rituximab and mesna, depending on your treatment plan and how you are responding.
Researchers will closely monitor how your body reacts to the treatment and how your cancer responds. The total duration of your participation would involve the treatment period and follow-up appointments, which could last for a significant time to track your progress and any long-term effects. The exact schedule of visits and treatments would be thoroughly explained by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedAustria
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedSweden
Common questions
What is Burkitt Lymphoma?
Burkitt Lymphoma is a type of fast-growing cancer that affects white blood cells called B-cells, which are part of your immune system.
What does 'relapsed/refractory' mean?
It means your cancer has either come back after being treated before (relapsed) or it hasn't responded well to previous treatments (refractory).
What is Tecartus?
Tecartus is a new type of treatment called CAR T-cell therapy, where your own immune cells are modified to fight cancer.
Will I receive other medicines during the study?
Yes, you might receive other chemotherapy drugs or steroids alongside or before the main Tecartus treatment as part of your care plan.
How long will I be in the study?
The study involves a treatment period and follow-up appointments, which could last for a significant time to track your progress. The exact duration will be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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