A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Diffuse large B-cell lymphoma (DLBCL) is a common type of blood cancer that affects white blood cells. While initial treatments often work well, the lymphoma can sometimes come back (relapse) or stop responding to standard therapies (refractory). This trial is looking at an oral medication called selinexor (KPT-330). Selinexor works inside cancer cells to trap natural cancer-fighting proteins where they can do their job, helping to stop cancer cells from growing and causing them to die. This is a Phase 2b 'open-label' study, meaning everyone in the trial receives selinexor and there is no dummy pill (placebo). The main aim is to find out how effective selinexor is at shrinking or controlling lymphoma in people with limited treatment choices. Doctors will also carefully track any side effects to make sure it is as safe as possible.
At a glance
What is this study about?
Diffuse large B-cell lymphoma (DLBCL) is a fast-growing cancer of the lymphatic system, which is part of your immune system. It causes abnormal white blood cells (B-cells) to multiply too quickly, often causing swelling in lymph nodes or organs. Many people respond well to standard chemotherapy, but for some, the cancer returns or stops responding. In these cases, finding new and effective treatments is essential.
This study is testing a drug named selinexor, also known as KPT-330. Normally, healthy cells have built-in 'watchdog' proteins that spot damage and tell abnormal cells to self-destruct. Cancer cells often push these protective proteins out of their control centre (the nucleus). Selinexor works by blocking the transport protein (XPO1) responsible for pumping them out. By keeping the protective proteins inside the nucleus, selinexor helps cancer cells destroy themselves.
Because this is an 'open-label' Phase 2b study, both you and your hospital team will know you are taking the study drug. Researchers will track how many participants see their tumours shrink, how long the benefit lasts, and how people feel during treatment.
This trial matters because having more treatment options gives patients with hard-to-treat lymphoma a better chance of keeping their disease under control and maintaining their quality of life.
Key takeaways
- Tests an oral targeted drug called selinexor for diffuse large B-cell lymphoma (DLBCL).
- Aimed at adults whose lymphoma has returned or stopped responding to standard treatments.
- This is an open-label Phase 2b trial, meaning there is no placebo.
- The main goals are to check how well the drug shrinks tumours and evaluate its safety.
- Participation is completely voluntary and you can leave at any time.
Who may be eligible?
To be considered for this trial, you must be 18 years of age or older and have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL). The trial is open to both men and women.
You must have lymphoma that has returned after previous treatments (relapsed) or that did not respond to standard treatment options (refractory). You will also need to be well enough to carry out day-to-day activities.
Like most clinical trials, you will need to meet safety criteria. This includes having reasonably good kidney, liver, and bone marrow function. People with certain serious ongoing medical conditions, active severe infections, or other uncontrolled illnesses may not be able to join. Your doctor can review your full medical history to see if you qualify.
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.
- I am aged 18 or older.
- I have been diagnosed with diffuse large B-cell lymphoma (DLBCL).
- My lymphoma has come back or not responded to prior therapies.
- I am able to take oral tablets.
- I am well enough to attend regular hospital appointments and scans.
What does participation involve?
If you take part, you will take selinexor as tablets by mouth on set days of the week, as guided by the study team. Before starting, you will undergo screening tests including blood tests, physical checks, and imaging scans (such as CT or PET scans) to assess your cancer. During the study, you will need to visit the hospital clinic regularly for check-ups, blood monitoring, and repeat scans to see how well the medicine is working. You will generally remain on the treatment for as long as it helps you and any side effects are manageable. After you stop taking the medicine, the study team will continue to check on your health and well-being through periodic follow-up appointments or phone calls.
Potential risks and benefits
Locations (3)
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedGreece
Common questions
What does 'open-label' mean?
An open-label study means that everyone involved—including you and your doctors—knows that you are receiving the active study medicine. There is no placebo (dummy pill).
How is the study medication taken?
Selinexor comes as tablets that you swallow with water. You will be given clear instructions on which days to take them.
Will I have to pay for the study treatment?
No, clinical trial medicines are provided free of charge. In many UK trials, travel expenses to and from the hospital may also be covered.
What if I experience unpleasant side effects?
You should tell your study team straight away. They can prescribe medications to relieve symptoms (such as anti-sickness tablets) or temporarily lower your dose.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the trial at any point, for any reason, and your regular NHS care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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