Clinical Trials for Chronic Lymphocytic Leukaemia Recurrent
There are currently 4 ongoing clinical trials investigating new treatments for chronic lymphocytic leukaemia that has returned after previous treatment. These studies are taking place across several European countries, including Germany, Poland, Italy, France, Austria, Romania, Spain, Bulgaria, and Hungary. The trials are testing innovative approaches including CAR T-cell therapies, targeted drug combinations, and novel medications designed to work in patients whose cancer has not responded to standard treatments or has come back after initial therapy.
Clinical trial locations
- Austria
- Bulgaria
- France
- Germany
- Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or B-Cell Malignancies
- Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
- Study on Venetoclax and Obinutuzumab for Adults with Recurring Chronic Lymphocytic Leukemia
- Hungary
- Italy
- Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
- Study on Venetoclax and Obinutuzumab for Adults with Recurring Chronic Lymphocytic Leukemia
- Study of NX-5948 in adults with relapsed or resistant chronic lymphocytic leukemia and small lymphocytic lymphoma who previously received BTK inhibitor and BCL-2 inhibitor treatment
- Poland
- Romania
- Spain
Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or B-Cell Malignancies
This long-term safety study is following patients who have previously received CAR T-cell therapy, an innovative treatment that uses the patient’s own immune cells to fight cancer. The study monitors patients with various B-cell blood cancers, including chronic lymphocytic leukaemia, for up to 15 years after their initial treatment.
Who can participate: Adults and children who received Miltenyi CAR T-cell therapy at least 12 months ago are eligible. Both male and female patients can participate, and the study is open to all age groups. Patients must be able to provide informed consent or have a legal guardian who can consent on their behalf.
Who cannot participate: Patients who have not received the specific Miltenyi CAR T-cell therapies, those with cancer types not included in the study, pregnant or breastfeeding women, and those unable to understand or agree to the study requirements are excluded. Patients currently participating in another clinical trial or with certain medical conditions that might interfere with the study are also not eligible.
What the study examines: The main focus is to monitor the long-term safety of CAR T-cell therapy. Researchers will track any late-onset side effects, serious health events, new cancers, or infections that may develop over time. The study also monitors specific blood cell counts and checks for the presence of remaining modified cells from the original therapy. For children, growth and development are also tracked. The study runs until the end of 2040.
Investigational treatment: This study does not provide new treatment but follows patients who previously received Miltenyi CAR T-Cell Therapy. This therapy involves collecting a patient’s T cells, modifying them in a laboratory to target cancer cells more effectively, and then returning them to the patient through an intravenous infusion.
Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
This study is testing different combinations of medications for patients whose B-cell blood cancer has returned or did not respond to previous treatments. The research aims to find safe and effective treatment combinations that can help patients who have run out of standard treatment options.
Who can participate: Adults aged 18 and over with confirmed relapsed or refractory B-cell blood cancers that can be measured according to the study protocol are eligible. Participants must be able to perform daily activities with minimal limitations and have adequate organ and kidney function. Women who can become pregnant must use effective birth control and have a negative pregnancy test before starting treatment. Men who are not sterile must also use effective birth control during the study.
Who cannot participate: People with active cancer involvement in the brain or spinal cord, those who received similar therapy recently, patients with active uncontrolled infections, significant heart problems, severe kidney or liver problems, and pregnant or breastfeeding women are excluded. People with a history of other cancers within the past 3 years, known HIV infection, active hepatitis B or C, uncontrolled high blood pressure, or serious mental conditions that could interfere with participation are also not eligible.
What the study examines: The trial is conducted in two parts: the first determines the right dose of drug combinations, while the second studies how well these doses work and what side effects they may cause. Researchers will monitor how many patients respond to treatment, how long the response lasts, and track any side effects throughout the study. For some patients, the amount of remaining cancer cells in blood or bone marrow will also be measured.
Investigational treatments: The study uses BGB-16673, an experimental BTK-degrader that works by breaking down a specific protein important in B-cell cancers. This medication is given as tablets taken by mouth and is combined with other treatments. Depending on the treatment group, patients may also receive zanubrutinib (oral capsules), obinutuzumab (intravenous infusion), glofitamab (intravenous infusion), or mosunetuzumab (injection under the skin).
Study on Venetoclax and Obinutuzumab for Adults with Recurring Chronic Lymphocytic Leukemia
This study evaluates the effectiveness and safety of combining two medications for patients whose chronic lymphocytic leukaemia has returned after previous treatment. The combination therapy aims to provide an option for patients who have previously responded well to these medications.
Who can participate: Adults with confirmed chronic lymphocytic leukaemia requiring retreatment are eligible. Participants must have previously completed treatment with venetoclax and an anti-CD20 antibody as their first treatment and shown a positive response. Depending on the study group, patients should be disease-free for either more than 24 months or between 12 to 24 months since their last venetoclax dose. Importantly, patients should not have received any other treatment for their condition after completing the previous venetoclax treatment and should not have stopped that treatment because their disease worsened.
Who cannot participate: Patients whose disease progressed during previous venetoclax treatment, those with active autoimmune blood disorders, patients whose leukaemia has transformed into a more aggressive cancer form, people who are in prison or unable to give consent freely, and those receiving other approved second-line therapies are excluded from participation.
What the study examines: The study monitors how patients respond to the treatment combination over time. Researchers will assess the overall response rate (the proportion of participants who show improvement), how long it takes for treatment to start working, how long the response lasts, and the time until any further treatment is needed. The study also evaluates progression-free survival and overall survival rates.
Investigational treatments: The study uses Venetoclax, taken as film-coated tablets by mouth, which works by blocking a protein called BCL-2 that helps cancer cells survive. This is combined with Obinutuzumab, given as an intravenous infusion, which is an antibody therapy that targets specific proteins on cancer cells to help the immune system recognize and destroy them.
Study of NX-5948 in adults with relapsed or resistant chronic lymphocytic leukemia and small lymphocytic lymphoma who previously received BTK inhibitor and BCL-2 inhibitor treatment
This study tests a new medication for patients whose chronic lymphocytic leukaemia or small lymphocytic lymphoma has returned or stopped responding to treatment. The research specifically targets patients who have already tried two common types of cancer medications and need additional treatment options.
Who can participate: Adults aged 18 and over with confirmed relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma that requires treatment are eligible. Participants must have previously received both a BTK inhibitor and a BCL-2 inhibitor. They must be able to perform light activities and self-care, have disease that can be measured by imaging tests like CT scans, and have adequate organ and bone marrow function.
Who cannot participate: Patients with Richter’s transformation (where the leukaemia changes into an aggressive lymphoma), active or uncontrolled autoimmune conditions, history of other cancers within the past 3 years (except successfully treated non-melanoma skin cancer or localized cancers), active cancer involvement in the brain or spinal cord, or major surgery within 4 weeks before starting treatment are excluded. People with significant heart problems, active uncontrolled infections, known HIV or hepatitis infections, pregnant or breastfeeding women, and those unable to swallow oral medications are also not eligible.
What the study examines: The research monitors how well the medication works in treating the blood cancer and tracks any side effects that occur. Doctors will perform regular check-ups, medical tests, and scans to measure how the disease responds to treatment. The study tracks how long treatment effects last, the time it takes for the disease to respond, and the duration of that response. Overall health status and survival are monitored throughout the study period.
Investigational treatment: The study uses NX-5948, an investigational medication taken as capsules by mouth. The maximum daily dose is 600 milligrams, and treatment continues in 28-day cycles. This novel drug represents a new approach to treating these blood cancers in patients who have not responded adequately to existing therapies.
Summary
The four ongoing clinical trials for recurrent chronic lymphocytic leukaemia reflect diverse approaches to treating this challenging condition. A notable concentration of trials is taking place in Germany and Italy, which participate in three out of four studies, suggesting these countries are important hubs for blood cancer research in Europe.
The trials showcase different treatment strategies: from long-term safety monitoring of innovative CAR T-cell therapies to testing novel drug combinations and new investigational medications. Two studies focus on patients who have already tried multiple treatments, specifically targeting those who received BTK and BCL-2 inhibitors. The venetoclax and obinutuzumab combination study uniquely focuses on retreatment for patients who previously responded well to these medications.
All studies emphasize careful patient selection and thorough monitoring for safety and effectiveness. The trials generally require participants to have adequate organ function and the ability to perform daily activities, while excluding those with serious concurrent health conditions. The geographical spread across nine European countries provides opportunities for patients in different regions to access these experimental treatments.