In short
There are currently 2 clinical trials investigating new treatments for lymphocytic leukaemia across several European countries. These studies are testing innovative therapies including immunotherapy and cell-based treatments for patients with newly diagnosed or relapsed disease.
Clinical trial locations
- Belgium
- Study on Blinatumomab, Ponatinib, and Isatuximab for Adults Aged 18-65 with Newly Diagnosed Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma
- Study on the Safety and Effectiveness of BCN-CP01 for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- France
- Netherlands
- Spain
Study on Blinatumomab, Ponatinib, and Isatuximab for Adults Aged 18-65 with Newly Diagnosed Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma
This trial is exploring new treatment approaches for adults recently diagnosed with Acute Lymphoblastic Leukemia (ALL) or T-Cell Lymphoblastic Lymphoma (T-LL). The study is being conducted in France and Belgium.
Who can participate:
This study is open to adults between 18 and 65 years old who have been newly diagnosed with ALL or T-LL. Eligible participants must have undergone specific tests to classify their cancer type, including immunophenotypic, cytogenetic, FISH, and molecular evaluations. Patients should not have received previous treatment for their condition, except for corticosteroids or intrathecal therapy. They must have a performance status score of 2 or less, meaning they are able to carry out most daily activities. Participants need to be eligible for a stem cell transplant procedure if they have certain types of ALL. Both men and women of childbearing potential must agree to use highly effective contraception methods during the study and for at least 6 months afterward.
Who cannot participate:
The trial excludes patients outside the 18-65 age range, those who have already received treatment for their condition, and patients with certain types of leukemia who are not eligible for the specific treatments being tested. People with other serious health conditions that might interfere with the study, those who are pregnant or breastfeeding, or those unable to follow study procedures or attend required visits are not eligible. Patients who have recently participated in another clinical trial or have a history of allergic reactions to the study medications are also excluded.
What the study involves:
The trial tests three investigational drugs: blinatumomab, isatuximab, and ponatinib. Blinatumomab is an immunotherapy that helps the immune system recognize and attack cancer cells. It is administered as an intravenous infusion directly into the bloodstream. Isatuximab is another immunotherapy that targets specific proteins on cancer cells, helping the immune system destroy them. It is also given through intravenous infusion. Ponatinib is an oral medication taken as a tablet that blocks certain proteins involved in cancer cell growth. This drug is specifically used for patients with a type of ALL positive for the Philadelphia chromosome.
Throughout the trial, participants receive regular monitoring through blood tests and health evaluations to assess how well the treatments are working and to check for any side effects. The study may also involve a stem cell transplant procedure for some patients. The goal is to determine if these new treatment combinations can improve survival rates and reduce the risk of cancer returning.
Study on the Safety and Effectiveness of BCN-CP01 for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This clinical trial is investigating a novel cell therapy called BCN-CP01 for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) whose disease has returned or not responded to previous treatments. The study is taking place in the Netherlands, Belgium, and Spain.
Who can participate:
Adults aged 18 years or older with confirmed CD19-positive CLL or SLL are eligible if their disease has relapsed or become refractory after at least two previous treatment lines. Patients must have tried or been unable to take certain medications such as BTK-inhibitors like ibrutinib or acalabrutinib, BCL2-inhibitors like venetoclax, or PI3K inhibitors. The disease must be measurable according to specific clinical guidelines. Participants need to have a performance status of 0 or 1, meaning they are either fully active or have some symptoms but can carry out light work. They must have adequate bone marrow, kidney, liver, and lung function, with oxygen levels above 92% on room air. Women of childbearing potential must have a negative pregnancy test before starting treatment. All participants must agree to use highly effective contraception from enrollment until at least 6 months after receiving treatment.
Who cannot participate:
The study excludes patients with cancer types other than CLL or SLL, those who are currently pregnant or breastfeeding, and patients with serious uncontrolled infections. People with a history of severe allergic reactions to similar medications or those with other serious medical conditions that could interfere with the study are not eligible. Patients unable to follow study procedures, those who have recently participated in another clinical trial, or those who have received certain treatments recently that could affect study results are also excluded.
What the study involves:
The trial uses BCN-CP01, a type of CAR T-cell therapy. This treatment involves taking a patient's own immune cells (T-cells), modifying them in a laboratory to better recognize and attack cancer cells that express the CD19 protein, and then infusing these modified cells back into the patient through intravenous infusion. The therapy is designed to help the immune system find and destroy cancer cells more effectively.
The study is divided into two phases. The first phase focuses on determining the safety of BCN-CP01 and observing initial signs of effectiveness. The second phase aims to further assess how well the treatment reduces cancer cells in the body. Throughout the study, participants undergo regular check-ups and tests to monitor their health and track how their cancer responds to the treatment. The goal is to evaluate whether BCN-CP01 can be a viable treatment option for patients whose disease has not responded to standard therapies.
Summary
These two clinical trials represent important research efforts in advancing treatment options for different types of lymphocytic leukaemia. The trials are distributed across four European countries, with Belgium participating in both studies, demonstrating its active role in leukaemia research. France and the Netherlands each host one trial, while Spain is involved in the BCN-CP01 study.
The studies target different patient populations and disease stages. The first trial focuses on newly diagnosed patients with acute forms of the disease, testing combination immunotherapy approaches with blinatumomab, isatuximab, and ponatinib. The second trial addresses patients with chronic forms whose disease has returned or not responded to multiple previous treatments, investigating innovative CAR T-cell therapy with BCN-CP01.
Both trials utilize immunotherapy approaches, reflecting current trends in cancer treatment that harness the body's own immune system to fight disease. The first study tests multiple targeted therapies in combination, while the second explores personalized cell therapy using modified immune cells. These different approaches offer hope for patients at various stages of their disease journey, from initial diagnosis to relapsed or refractory cases.
