A Modular Phase II, Open-Label, Multicentre Study to Assess the Efficacy and Safety of Capivasertib in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL)
This UK study is looking into a new tablet medicine called Capivasertib, sometimes known as TRUQAP, for adults aged 18 and over who have a type of blood cancer called B-cell non-Hodgkin lymphoma. This is for people whose cancer has either returned after treatment or didn't get better with their previous treatments. The main goal is to see how many people respond to this new medicine, meaning their cancer shrinks or disappears. Researchers will also be checking how long any improvements last, how long people live without the cancer getting worse, and their overall health and quality of life while taking the medicine. Safety is very important, so they'll carefully watch for any side effects and how the body handles the drug.
At a glance
What is this study about?
This study, called CAPITAL, is a clinical trial happening in different hospitals across the UK. It's investigating a new tablet treatment called Capivasertib (you might also hear it called TRUQAP) for adults diagnosed with a type of blood cancer called B-cell non-Hodgkin lymphoma. This particular study is for people whose lymphoma has either come back after they've had treatment, or didn't get better with the treatments they've tried so far.
The main purpose of this study is to find out how well Capivasertib works. Specifically, the doctors want to see if the medicine can make the cancer shrink or even disappear (what they call a 'response'). They'll be looking carefully at scan results, which will be checked by independent experts, to measure this. They also want to understand if the medicine helps people live longer without their cancer growing, and how long any benefits last.
Another very important part of the study is to understand the safety of Capivasertib. Researchers will be keeping a close eye on any side effects people experience and how they generally feel. They'll also ask about daily life, symptoms, and overall well-being. This information helps doctors understand the full picture of how the treatment affects patients.
Key takeaways
- Tests the new drug Capivasertib (TRUQAP) for B-cell non-Hodgkin lymphoma.
- For lymphoma that has returned or didn't respond to previous treatments.
- Main goal: see if the drug shrinks or gets rid of the cancer.
- Also checks safety, side effects, and how patients feel day-to-day.
- Open to adults aged 18 and over in the UK.
- Participation involves taking tablets and regular hospital visits for checks.
Who may be eligible?
This study is open to adults aged 18 and older. It's for men and women with B-cell non-Hodgkin lymphoma. To be considered, your lymphoma must have either returned after you've had treatment for it, or it didn't respond well to the treatments you've already received.
As with all clinical trials, there will be other specific health requirements and tests to make sure that taking part is safe for you and that the study results are clear. For example, doctors will need to check your general health, including your heart, kidneys, and liver, through blood tests and other assessments.
It's important to discuss your full medical history with the study team. They will be able to tell you if you meet all the necessary criteria to join this research study. Don't hesitate to ask them any questions you have about whether you could be a good fit.
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?
- Do you have B-cell non-Hodgkin lymphoma?
- Has your lymphoma come back after treatment or not gotten better with previous treatments?
- Are you generally healthy enough to take part in a clinical study? (Your doctor will confirm this).
What does participation involve?
If you decide to take part in this study, you'll be given Capivasertib tablets to take. There are two possible doses being studied: 200 mg or 160 mg. You'll take these tablets as instructed by the study team.
You'll have regular visits to the hospital or clinic. During these visits, doctors and nurses will check your health, ask about how you're feeling, and monitor for any side effects. You'll also have blood tests, heart checks (ECGs), and scans to see how your lymphoma is responding to the treatment. You'll also be asked to fill out questionnaires about your symptoms and how the treatment affects your daily life.
The study also involves collecting blood samples at specific times to measure how much of the study drug is in your body. The whole duration of your participation will depend on how you respond to the treatment and the study's follow-up plan, but it will involve ongoing assessments and check-ups.
Potential risks and benefits
Locations (1)
- —UnverifiedSpain
Common questions
What is Capivasertib (TRUQAP)?
Capivasertib, also known as TRUQAP, is a new tablet medicine being tested to see if it can help treat non-Hodgkin lymphoma that has returned or hasn't responded to other treatments.
What kind of cancer is this study for?
This study is for adults with B-cell non-Hodgkin lymphoma, specifically when the cancer has reappeared or didn't get better with previous treatments.
What does a 'response' mean in this study?
A 'response' means that the cancer has shrunk or completely disappeared. Doctors will use scans and special rules to figure this out.
Will I know if I'm getting the active drug?
Yes, in this study, everyone who takes part will receive Capivasertib at either a 200 mg or 160 mg dose. It's not a placebo-controlled study.
How long will I be in the study?
The length of your participation will depend on how your lymphoma responds to the treatment and the follow-up plans, which the study team will explain in more detail.
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.