Clinical Trials for Chronic Lymphocytic Leukaemia Refractory
This article provides information about 5 ongoing clinical trials for patients with chronic lymphocytic leukaemia that has not responded to previous treatments or has returned after initial therapy. These trials are testing new cell therapies, targeted medications, and combination treatments across several European countries including Germany, Poland, Italy, France, Hungary, Croatia, and Czechia.
Clinical trial locations
- Croatia
- Czechia
- France
- Germany
- Hungary
- 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
- Study Comparing Acalabrutinib to Standard Treatments for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
- Italy
- Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
- Study on PTG-CARCIK-CD19 for Adults and Children with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma and 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
- Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
- 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
- Study Comparing Acalabrutinib to Standard Treatments for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or B-Cell Malignancies
This trial focuses on the long-term safety monitoring of patients who have received innovative cell therapy treatments called CAR T-cell therapies. The study is designed for patients who have already undergone treatment with Miltenyi cell and gene therapies for various blood cancers, including chronic lymphocytic leukaemia that has not responded to standard treatment.
Main inclusion criteria: Patients must have received Miltenyi CAR T-cell therapy at least 12 months before joining this follow-up study. Both adults and children who have been treated with these therapies can participate. Patients must be able to understand and provide informed consent for the study.
Main exclusion criteria: Patients with cancer types not specified in the study cannot participate. Those who have not experienced disease progression after previous treatments, or who lack specific markers on their cancer cells, are also excluded. Pregnant or breastfeeding women and patients currently participating in other clinical trials are not eligible.
Focus and goal: The primary purpose of this study is to evaluate the long-term safety of CAR T-cell therapies. Researchers will monitor participants for any late-onset side effects, serious health events, new cancers, or serious infections. The study will track the presence of modified cells in the blood and other health indicators over time. Regular follow-up visits will assess whether the cancer has returned and monitor overall survival rates. The study is expected to continue until 2040.
Investigational treatment: Miltenyi CAR T-cell therapy uses the patient’s own immune cells (T cells), which are collected and modified in a laboratory to better recognize and attack cancer cells. These modified cells express special structures called chimeric antigen receptors (CARs) that target specific proteins on cancer cells. After modification, the cells are infused back into the patient to enhance the body’s natural ability to fight cancer.
Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
This trial is testing various combinations of medications for patients whose B-cell blood cancers have returned or not responded to previous treatments. The study evaluates BGB-16673 in combination with other cancer medications to find safe and effective treatment options.
Main inclusion criteria: Patients must be at least 18 years old with confirmed relapsed or refractory B-cell malignancy. They must have disease that can be measured according to the study protocol and good physical function with an ECOG performance status of 0-1, meaning they can perform daily activities with minimal limitations. Adequate organ and kidney function is required. For certain parts of the study, patients must either be new to BTK inhibitor treatment or have stopped such treatment for reasons other than disease progression. Women who can become pregnant must use effective birth control and have a negative pregnancy test before starting treatment.
Main exclusion criteria: Patients under 18 years old cannot participate. Those with active central nervous system involvement from their cancer, uncontrolled infections, significant heart problems, or severe kidney or liver problems are excluded. Pregnant or breastfeeding women, those with a history of other cancers within the past three years, and patients with known HIV, hepatitis B, or hepatitis C infections are not eligible. Patients who have had major surgery within four weeks before the study or those with mental conditions that could interfere with participation are also excluded.
Focus and goal: The study aims to determine the right dose of drug combinations and evaluate how well these doses work. Throughout the trial, doctors will monitor patients’ health, check treatment effectiveness, and track side effects. They will measure how many patients respond to treatment and how long the response lasts. The study is conducted in two parts: dose-finding and further evaluation of safety and effectiveness.
Investigational treatment: BGB-16673 is an experimental BTK-degrader that works by breaking down a specific protein important in B-cell cancers. It is taken as tablets by mouth and is being studied in combination with other agents including zanubrutinib, sonrotoclax, mosunetuzumab, obinutuzumab, and glofitamab. Some medications are given orally while others are administered through intravenous infusion or subcutaneous injection.
Study on PTG-CARCIK-CD19 for Adults and Children with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
This trial tests a novel cell therapy approach for blood cancers that have not responded to previous treatments. The study includes both adults and children and uses specially modified immune cells from a family member to target cancer cells.
Main inclusion criteria: Patients must be children aged 1-17 years or adults aged 18 years or older with confirmed B-cell cancers including Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia. The cancer must have returned or not responded to at least two previous treatments, with no other treatment options expected to help, or the patient must refuse such treatments. Patients must have at least one measurable area of cancer detected by CT scan or have cancer in the bone marrow or spleen. A family member who is at least a half-match genetically and willing to donate blood cells is required. Patients must have a certain level of physical ability to perform daily activities.
Main exclusion criteria: Patients with medical conditions other than B-Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia cannot participate. Those not within the specified age ranges or who are part of a vulnerable population requiring special protection are excluded.
Focus and goal: The study aims to determine the safety and effectiveness of PTG-CARCIK-CD19 treatment. Researchers will monitor how well the treatment works and how long the modified cells remain active in the body. Participants will receive regular check-ups to track their health and response to treatment. The study evaluates the overall response rate and monitors for any side effects or changes in condition throughout the study period, which is expected to conclude in September 2027.
Investigational treatment: CARCIK-CD19 involves using specially modified immune cells called CIK cells taken from a donor. These cells are engineered to express a chimeric antigen receptor (CAR) that targets CD19, a protein found on certain cancer cells. The treatment is administered through an intravenous infusion, with the goal of helping the immune system recognize and attack cancer cells.
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 focuses specifically on patients whose cancer has returned or not responded after treatment with two types of targeted cancer medicines: BTK inhibitors and BCL-2 inhibitors. It tests a new oral medication called NX-5948 that represents a different approach to treating these blood cancers.
Main inclusion criteria: Patients must be 18 years or older with confirmed relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma that requires treatment according to established medical criteria. They must have an ECOG performance status of 0-2, meaning they can perform at least light activities and self-care. Previous treatment with both a BTK inhibitor and a BCL-2 inhibitor is required. Patients must have disease that can be measured by imaging tests and have adequate organ and bone marrow function.
Main exclusion criteria: Patients with a prior diagnosis of Richter’s transformation (where chronic lymphocytic leukaemia changes into an aggressive lymphoma) are excluded. Those with active or uncontrolled autoimmune conditions, history of other cancers within the past three years, known active central nervous system involvement, or major surgery within four weeks are not eligible. Significant heart problems including recent heart attack, uncontrolled irregular heartbeat, or severe heart failure exclude participation. Active uncontrolled infections, known infection with HIV, hepatitis B or C, pregnancy, breastfeeding, inability to swallow oral medications, or current participation in other investigational drug studies also exclude patients.
Focus and goal: The study aims to determine how well NX-5948 works in treating these blood cancers. Throughout the trial, doctors monitor participants’ health through regular check-ups and medical tests. They track how the cancer responds to treatment, measure how long the treatment effects last, and document any side effects. Response evaluation is conducted by both study doctors and independent reviewers using regular scans.
Investigational treatment: NX-5948 is taken as a capsule by mouth daily, with a maximum daily dose of up to 600 milligrams. Treatment may continue for up to 28 days per treatment cycle. This medication targets specific molecular pathways involved in blood cancer progression and represents a new treatment option for patients who have not responded adequately to existing therapies.
Study Comparing Acalabrutinib to Standard Treatments for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
This trial compares the effectiveness of a medication called Acalabrutinib with other standard treatment combinations for patients whose disease has returned or not responded to previous therapies. The study helps determine whether Acalabrutinib alone works as well as or better than existing treatment options.
Main inclusion criteria: Men and women must be 18 years or older. Participants must be willing and able to take part in all required evaluations and procedures, including the ability to swallow capsules without difficulty. They must have an ECOG performance status of 0 to 2, which measures how the disease affects daily living abilities. A diagnosis of chronic lymphocytic leukaemia meeting specific criteria is required, including documented CD20-positive disease. Participants must have active disease meeting at least one criterion for requiring treatment, such as worsening anaemia, enlarged spleen or lymph nodes, or certain symptoms like weight loss or fever. They must meet specific laboratory parameters for blood cell levels and liver function. At least one prior systemic therapy for the disease is required. Women who can have children and men who can father children must agree to use highly effective contraception during the study and for a specified time afterward.
Main exclusion criteria: Patients with a different type of cancer other than chronic lymphocytic leukaemia are excluded. Those not within the specified age range or not part of the clinical trial group being studied cannot participate.
Focus and goal: The study evaluates the time until disease progression or death, known as progression-free survival. Participants are randomly assigned to receive either Acalabrutinib or one of the standard treatment combinations (Idelalisib with Rituximab, or Bendamustine with Rituximab). Throughout the study, participants undergo regular assessments to track their health and disease status. The trial monitors disease progression and any side effects experienced by participants. The study is expected to continue until June 2027.
Investigational treatments: Acalabrutinib is taken as hard capsules by mouth and works by blocking a specific protein in cancer cells to stop their growth and spread. The comparison treatments include Idelalisib (a medication targeting certain pathways in cancer cells) combined with Rituximab (an antibody that helps the immune system destroy cancer cells), or Bendamustine (a chemotherapy drug that damages cancer cell DNA) combined with Rituximab. These combinations are standard treatments for patients whose cancer has returned or not responded to other treatments.
Summary
These five clinical trials offer different treatment approaches for patients with chronic lymphocytic leukaemia that has not responded to previous treatments. The trials span across multiple European countries, with Poland and Italy being the most common locations, appearing in three trials each. Germany, Hungary, and France each host two trials, while Croatia and Czechia participate in one trial each.
A notable feature of these trials is the diversity of therapeutic approaches being investigated. Three trials focus on novel targeted oral medications (BGB-16673, NX-5948, and Acalabrutinib), while two trials evaluate innovative cell therapies (CAR T-cell therapies from Miltenyi and CARCIK-CD19). The cell therapy trials are particularly notable as they represent cutting-edge approaches that use modified immune cells to fight cancer.
Several trials are specifically designed for patients who have already received multiple lines of treatment. The NX-5948 trial specifically requires patients to have been treated with both BTK inhibitors and BCL-2 inhibitors, addressing an important group of patients with limited treatment options. The long-term follow-up study for Miltenyi CAR T-cell therapies extends until 2040, demonstrating a commitment to understanding the lasting effects of these innovative treatments.
Most trials include both adults and some include children, with the CARCIK-CD19 study explicitly including pediatric patients as young as one year old. This inclusivity ensures that treatment options are being developed for patients across different age groups. Patients interested in participating should discuss eligibility criteria with their healthcare providers to determine which trial might be most appropriate for their specific situation.
