A Phase 1b Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in Relapsed or Refractory B cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
This study is for adults diagnosed with non-Hodgkin lymphoma or chronic lymphocytic leukaemia that has come back or hasn't responded to previous treatments. It's an early-stage clinical trial (Phase 1b), which means doctors are testing a new combination of two medicines: JNJ-67856633 and ibrutinib. The main goal is to find out if this combination is safe and what dose works best. It also aims to see if the medicines can help control the cancer. This type of research is important for finding new ways to treat these conditions, especially when standard treatments haven't been successful.
At a glance
What is this study about?
This research study is looking at a new way to treat two types of blood cancer: non-Hodgkin lymphoma and chronic lymphocytic leukaemia. These conditions affect white blood cells in your body. Sometimes, these cancers can be difficult to treat, or they might come back after treatment. This study is for people in that situation – where previous treatments haven't worked or the cancer has returned.
The study involves trying a new combination of two different medicines. One is a new medicine called JNJ-67856633, and the other is a medicine called ibrutinib, which is already used for some blood cancers. By combining them, doctors hope to find a more effective way to fight the cancer cells. This is an early-stage study, which is called a Phase 1b trial. This means the main goals are to make sure the treatment is safe for people to take and to find the right amount (dose) of medicine to give. They will also be looking to see if the combination helps people feel better or helps control their cancer.
Taking part in studies like this is really important. It helps doctors learn more about diseases and find new and better treatments for patients in the future. It's a key step in medical progress, especially for people whose cancer hasn't responded well to standard care.
Key takeaways
- This study is testing a new combination of medicines for certain blood cancers.
- It's for adults whose non-Hodgkin lymphoma or chronic lymphocytic leukaemia has come back or hasn't responded to previous treatment.
- The main goals are to check the safety and find the right dose of the combined medicines.
- Participation involves regular hospital visits for treatments and health checks.
- There are potential benefits and risks, which will be fully explained.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults aged 18 or older. Both men and women can take part. To be considered, you must have been diagnosed with either non-Hodgkin lymphoma or chronic lymphocytic leukaemia.
Crucially, your cancer must either have come back after previous treatment, or it must not have responded to treatment you've already had. This study is specifically for those who need new treatment options.
There will be other specific health checks and tests to make sure that taking part in the study is safe for you. These will be explained in full by the study team.
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 non-Hodgkin lymphoma or chronic lymphocytic leukaemia?
- Has your cancer come back after treatment, or did it not respond to previous treatments?
- Are you willing to attend regular hospital appointments?
What does participation involve?
If you decide to take part in this study, you will be given two medicines: JNJ-67856633 and ibrutinib. The study team will explain exactly how to take them. You will need to attend regular appointments at the hospital or clinic. These visits will involve various tests, such as blood tests, physical examinations, and scans, to check how you are doing, monitor the effects of the medicines, and see if the treatment is working. Doctors will also check for any side effects.
The exact number and timing of visits will be explained by the study team, but they will be more frequent at the beginning of the study. You will be closely monitored throughout. After you finish taking the study medicines, there will be follow-up appointments to check on your health long-term. The total time you spend in the study, from starting the medicine to the final follow-up, will be clearly outlined by the study team.
Potential risks and benefits
Locations (2)
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What kind of cancer is this study for?
This study is for people with certain types of blood cancer: non-Hodgkin lymphoma and chronic lymphocytic leukaemia.
What does 'relapsed or refractory' mean?
It means your cancer has either come back after treatment (relapsed) or it hasn't responded to previous treatments (refractory).
What do 'Phase 1b' and 'Human Pharmacology' mean?
Phase 1b means this is an early study to check if the new medicine combination is safe and to find the best dose. Human Pharmacology refers to studies that examine how new medicines affect the body.
Are these new medicines or ones already used?
This study is looking at a new combination of two medicines: JNJ-67856633, which is new, and ibrutinib, which is already used for some blood cancers.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without having to give a reason, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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