A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory BCell Non Hodgkin Lymphoma (ZUMA-4)
This study is looking at a new treatment called Tecartus for young people (children and teenagers) who have acute lymphoblastic leukaemia (ALL) or B-cell non-Hodgkin lymphoma (NHL). These are types of blood and lymph cancers that have returned or not responded to previous treatments. The main goals are to check the safety of Tecartus in the first part of the study. In the second part, we want to see how many patients with ALL or NHL go into remission (where the cancer signs go away). We'll also be looking at how long people stay well, their quality of life, and any side effects. This research aims to find better ways to treat these challenging cancers in young patients.
At a glance
What is this study about?
This study is about a new treatment called Tecartus for young people who have a specific type of blood cancer. This cancer, called acute lymphoblastic leukaemia (ALL) or B-cell non-Hodgkin lymphoma (NHL), can sometimes be very difficult to treat, especially if it comes back after initial treatments or doesn't get better. When doctors say a cancer has 'relapsed' or is 'refractory,' it means it has returned or isn't responding to standard treatments.
Tecartus is a type of treatment that uses your own immune cells, called T-cells, to fight the cancer. We want to find out if this treatment is safe for children and teenagers and how well it helps their bodies fight the cancer. The study is divided into two main parts. The first part focuses on safety, making sure the treatment doesn't cause too many serious side effects. The second part looks at how many patients go into remission, which means the cancer is no longer detectable. We will also be tracking how long patients stay in remission, their overall health, and any other effects of the treatment.
The information gathered from this study is really important. It helps doctors understand if Tecartus could be a good new option for young people with these challenging cancers. By carefully checking both the safety and effectiveness, we hope to improve the treatment choices available for children and teenagers in the future.
Key takeaways
- New treatment for leukaemia or lymphoma that has returned or not responded.
- Specifically for patients aged 18 and over.
- Tests the safety and effectiveness of Tecartus.
- Aims to achieve remission and track long-term health.
- All treatment risks and benefits will be explained.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, patients need to meet certain conditions. It's for young people aged 18 or older. Both males and females can take part.
More importantly, the study is specifically for those who have a diagnosis of Acute Lymphoblastic Leukaemia (ALL) or B-cell Non-Hodgkin Lymphoma (NHL) that has either come back after previous treatment (relapsed) or has not responded to treatment (refractory).
There will be other detailed medical checks to make sure the treatment is suitable and safe for each person. These will be discussed fully by the study doctors.
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 Acute Lymphoblastic Leukaemia (ALL) or B-cell Non-Hodgkin Lymphoma (NHL)?
- Has your cancer come back after treatment, or did it not get better with previous treatments?
- Are you able to attend regular hospital appointments for tests and treatment?
What does participation involve?
Taking part in this study would involve receiving the Tecartus treatment as an infusion, which means it's given through a drip into a vein. You would have regular check-ups with the study team to monitor your health, look for any side effects, and see how well the treatment is working. This will include blood tests and possibly other scans or tests. The study has different phases, with more intense monitoring at the beginning and then follow-up appointments over a longer period to see the long-term effects. The total duration of participation, including follow-up, can vary.
Potential risks and benefits
Locations (6)
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedGermany
Common questions
What kind of cancer is this study for?
This study is for certain types of blood cancer called acute lymphoblastic leukaemia (ALL) and B-cell non-Hodgkin lymphoma (NHL) in young people, specifically when the cancer has returned or didn't respond to previous treatments.
What is Tecartus?
Tecartus is a new type of treatment that uses a patient's own immune cells to help fight the cancer. It's given through a drip.
Will I get better if I join this study?
We cannot guarantee that you will get better. The aim of the study is to find out if this new treatment helps people and if it is safe.
What age do I need to be to join?
This particular study is for people aged 18 years and older. There might be other studies for younger children.
What are the main things the researchers are looking for?
They are mainly looking at how safe the treatment is and how many patients go into remission (their cancer signs disappear or get much better).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.