Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
This UK-based study is exploring a new medication called Selinexor for adults diagnosed with an aggressive blood cancer known as Diffuse Large B-cell Lymphoma (DLBCL). This particular study focuses on individuals whose cancer has returned after previous treatments, or whose cancer hasn't responded to standard therapies. These are patients who currently have very limited treatment options. The purpose of this Phase 2 study is to understand how well Selinexor works and what doses might be most effective. Participants will take Selinexor by mouth, and the study will monitor their progress to see if the medicine helps control their cancer. It's a way to investigate potential new treatments for this challenging type of lymphoma.
At a glance
What is this study about?
This study, called a Phase 2 trial, is for people in the UK who have Diffuse Large B-cell Lymphoma (DLBCL). DLBCL is a type of cancer that affects a specific kind of white blood cell. It's considered 'relapsed' when it comes back after treatment, or 'refractory' when it hasn't responded to previous treatments. For people in this situation, finding effective new treatments is really important.
The research is looking at an experimental medicine called Selinexor. This medicine works differently from many standard treatments. The study aims to find out if Selinexor can help manage the cancer in people who have run out of other standard treatment options. It's a 'multicenter' study, meaning it's happening in several medical centres, and it's 'open-label,' which means both you and your doctors will know you are receiving Selinexor.
The study is split into two parts. In the first part, 130 participants will receive a specific dose of Selinexor. In the second part, about 110 participants will be randomly assigned to receive one of two different doses of Selinexor (40mg or 60mg) to help researchers understand the best approach. The medicine will be taken by mouth. Researchers will then closely follow everyone involved to see how their cancer responds and how they feel während the treatment.
Key takeaways
- Tests a new medicine, Selinexor, for DLBCL.
- Aimed at people whose DLBCL has returned or not responded to other treatments.
- Involves taking Selinexor by mouth.
- Monitors how the cancer responds and your well-being.
- Requires meeting specific health and past treatment criteria.
- Your participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. You must have a confirmed diagnosis of Diffuse Large B-cell Lymphoma (DLBCL) that has either returned or not responded to at least two, but no more than five, previous lines of treatment. This includes receiving at least one treatment for your cancer that contained an anthracycline-based chemotherapy (unless your heart health prevented it) and at least one treatment with an anti-CD20 medicine like rituximab (unless you couldn't tolerate it).
Your general health needs to be good enough to participate, and doctors will assess this with a performance status score of 2 or less. They also expect you to have a life expectancy of more than 3 months. If you've had a stem cell transplant before, you might still be eligible.
It's also important for women who could become pregnant to have a negative pregnancy test and agree to use reliable contraception during and for 3 months after the study. Men who could father a child must also use reliable contraception during the study and for 3 months after the last dose.
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 Diffuse Large B-cell Lymphoma (DLBCL) that has recurred or not responded to previous treatments?
- Have you had at least 2, but no more than 5, previous treatments for your DLBCL?
- Are you able to take medicines by mouth?
- Are you generally well enough for a study, as assessed by a doctor (ECOG performance status ≤2)?
- If you are a woman who could get pregnant, are you willing to use reliable contraception during and after the study?
What does participation involve?
If you decide to participate, you would first provide your informed consent, which means you've understood the study and agreed to join. You'll then undergo screening tests to confirm you meet all the eligibility criteria. Once enrolled, you will take Selinexor medicine by mouth. Depending on which part of the study you are in, you'll receive either a fixed dose or be randomly assigned to one of two different doses.
You'll continue taking Selinexor until your cancer gets worse or if the side effects become too difficult to manage. Throughout the study, you'll have regular hospital visits for assessments, which will likely include blood tests, health checks, and scans to monitor your cancer’s response and your general well-being. Even after you stop taking Selinexor, the study team will continue to follow your health and the progression of your disease for a period, until disease progression or death.
Potential risks and benefits
Locations (175)
- UACC ArizonaVerified postcodeTucson, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- University of California Los Angeles (UCLA)Verified postcodeSanta Monica, United States
- Boca Raton Cancer Research Medical CenterVerified postcodePlantation, United States
- University of ChicagoVerified postcodeChicago, United States
- Robert H. Lurie Comprehensive Cancer Center/Northwestern UniversityVerified postcodeChicago, United States
- Norton Cancer InstituteVerified postcodeLouisville, United States
- Dana Farber Cancer InstituteVerified postcodeBoston, United States
- Tufts Medical CenterVerified postcodeBoston, United States
- Lahey ClinicVerified postcodeBurlington, United States
- University of Massachusetts Medical SchoolVerified postcodeWorcester, United States
- John Theurer Cancer Center at Hackensack University Medical CenterVerified postcodeHackensack, United States
Common questions
What is Diffuse Large B-cell Lymphoma (DLBCL)?
DLBCL is an aggressive type of cancer that starts in white blood cells called lymphocytes.
What does 'relapsed/refractory' mean?
It means the cancer has come back after previous treatments (relapsed) or hasn't responded to previous treatments (refractory).
What is Selinexor?
Selinexor is an experimental medicine being tested to see if it can help treat DLBCL, especially when other treatments haven't worked.
Will I know if I'm getting the active drug?
Yes, this is an 'open-label' study, meaning both you and your medical team will know you are receiving Selinexor.
How long will I be on the study medication?
You will take Selinexor until your cancer progresses or if the side effects become too difficult to manage.
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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