A Multi-Center, Open Label, Uncontrolled, Phase 2a Clinical Trial Evaluating the Safety and Efficacy of the Addition of Ibrutinib to Venetoclax through a MRD-guided Approach in Relapsed/Refractory Patients with Chronic Lymphocytic Leukemia (CLL) IMPROVE (Ibrutinib treatment based on MRD-guided apPROach combined with VEnetoclax)
Chronic lymphocytic leukaemia (CLL) is a type of blood cancer. While treatments can work well, the condition often returns or stops responding over time. This phase 2 clinical trial is looking at a more personalised approach for adults with relapsed or refractory CLL. Participants take a targeted medicine called venetoclax. Doctors then use very sensitive blood tests to check for tiny amounts of leukaemia cells that standard tests cannot see. This is called testing for 'minimal residual disease' (MRD). If tiny traces remain, doctors add a second targeted drug called ibrutinib. The main goal is to find out if using these sensitive test results to guide treatment is safe and helps clear the cancer completely. This could help doctors tailor therapy more closely to each person's needs in the future.
At a glance
What is this study about?
Chronic lymphocytic leukaemia (CLL) affects white blood cells called lymphocytes. Although many people live well with CLL for years, the cancer can sometimes come back after previous treatment (relapsed) or stop responding to standard drugs (refractory). When this happens, doctors need newer, more effective treatment options.
In this study, researchers are testing a tailored approach using two targeted drugs: venetoclax and ibrutinib. Instead of chemotherapy, which attacks healthy and cancerous cells alike, these drugs work by blocking specific signals that leukaemia cells need to survive and grow. Both medicines are taken as daily tablets.
The unique part of this trial is how treatment is guided. Doctors will perform sensitive lab tests to check for 'minimal residual disease' (MRD). This means searching for tiny numbers of cancer cells that might still be hiding in the blood or bone marrow, even if the person feels completely well. If these tiny traces are found, ibrutinib is added to venetoclax to help clear them away.
By matching the intensity of treatment to the exact amount of leukaemia left in the body, researchers hope to achieve deeper, longer-lasting remissions while avoiding unnecessary medicines when they are not needed.
Key takeaways
- This phase 2 trial tests a personalised combination of targeted tablets for relapsed or refractory CLL.
- Treatment is guided by sensitive blood tests that look for tiny amounts of hidden leukaemia cells.
- If hidden cells are found, ibrutinib is added to venetoclax to try and clear them completely.
- Participants take daily oral tablets and attend regular hospital check-ups and blood tests.
- Participation is entirely voluntary, and you can leave the study at any point.
Who may be eligible?
This trial is designed for adults aged 18 and over who have been diagnosed with chronic lymphocytic leukaemia (CLL). It is specifically for people whose leukaemia has either returned after earlier treatment or did not respond well enough to past therapies.
Because this study involves active medical treatment, participants must be well enough to attend regular hospital appointments and take daily tablets. Doctors will also check that your heart, liver, and kidneys are working well enough to process the trial medicines safely.
You may not be able to join if you have certain other serious medical conditions, an active severe infection, or if you are pregnant or breastfeeding. Your haematology team will review your complete medical history and past treatments to see if this study is suitable for you.
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 chronic lymphocytic leukaemia (CLL).
- My leukaemia has returned or stopped responding after previous treatment.
- I am able to swallow tablets each day.
- I can attend regular hospital check-ups and monitoring visits.
What does participation involve?
Taking part in this study involves taking daily oral tablets at home and attending regular hospital visits. At first, you will take venetoclax. The dose is usually increased gradually over a few weeks to allow your body to adjust safely.
During clinic visits, your healthcare team will monitor your health, check your vital signs, and take routine blood samples. You will also have specialised blood tests (and sometimes bone marrow checks) to look for hidden cancer cells. If these sensitive tests show that leukaemia cells remain, your doctor will add ibrutinib tablets to your daily routine.
Clinic visits are more frequent during the first few months and become less frequent once your dose is stable. Total treatment and follow-up can last for several months to a few years, depending on how your leukaemia responds to the medicines.
Potential risks and benefits
Locations (1)
- —UnverifiedItaly
Common questions
What does 'MRD-guided' mean?
MRD stands for minimal residual disease. It refers to tiny numbers of cancer cells that remain after treatment. 'MRD-guided' means doctors use sensitive tests to find these hidden cells and decide whether to add an extra medicine.
Are venetoclax and ibrutinib forms of chemotherapy?
No. They are targeted therapies. Instead of affecting all fast-growing cells like chemotherapy does, they work by blocking specific proteins inside the leukaemia cells.
How are these trial medicines taken?
Both venetoclax and ibrutinib are taken as tablets or capsules by mouth, usually once a day with water.
Do I have to pay to take part in the trial?
No. In the UK, clinical trial medications and trial-related tests are provided free of charge, though you should check if help with travel costs is available.
Can I leave the study if I change my mind?
Yes. You have the right to leave the study at any time, for any reason, without giving an explanation. Your normal medical care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.