Ongoing Clinical Trials for B Precursor Type Acute Leukaemia
There are currently 3 ongoing clinical trials testing new treatments for B Precursor Type Acute Leukaemia. These trials are exploring advanced therapies including CAR T-cell treatments and targeted immunotherapies in Denmark, Poland, Belgium, and the Netherlands. The studies focus on patients whose disease has returned after treatment or has not responded to standard therapies.
Clinical trial locations
- Belgium
- Denmark
- Netherlands
- Poland
Study on CLIC-1901 CAR T-cells and Tocilizumab for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma
This trial is testing a novel CAR T-cell therapy called CLIC-1901 in Denmark. The treatment involves collecting white blood cells from the patient, modifying them in a laboratory to recognize and attack cancer cells expressing the CD19 protein, and then infusing them back into the patient’s bloodstream.
Who can participate: Patients aged 1 to 70 years whose blood cancer has returned or not responded to previous treatment. Participants must have a life expectancy of at least 12 weeks and adequate organ function, including lung capacity of at least 40%, heart function above 45%, and acceptable liver and kidney function. A signed consent form is required, and participants capable of having children must agree to use effective birth control for at least 12 months after treatment.
Who cannot participate: Patients outside the specified age range, those who are part of vulnerable populations requiring special protection, and individuals who do not meet the organ function requirements.
Main focus: The trial aims to evaluate the safety and feasibility of CLIC-1901 CAR T-cell therapy. The study includes a preparation phase where white blood cells are collected through leukapheresis, followed by several weeks of cell modification in the laboratory. Patients may receive chemotherapy before the CAR T-cell infusion to prepare the body. After the single infusion, participants are closely monitored for side effects such as cytokine release syndrome and neurotoxicity. The medication tocilizumab may be used to manage these side effects if they occur.
Investigational drug: CLIC-1901 CAR T-cells, which are the patient’s own immune cells engineered to target and destroy cancer cells expressing the CD19 protein.
Study of Tisagenlecleucel for Treating Adult Patients with Resistant or Relapsed B-cell Acute Lymphoblastic Leukemia
This Polish trial is studying tisagenlecleucel, also known as Tarcidomgen Kimleucel or FCTX-CL19-1, another type of CAR T-cell therapy. Like the Danish study, this treatment modifies a patient’s immune cells to better recognize and attack cancer cells.
Who can participate: Adults over 18 years old with B-cell acute lymphoblastic leukemia that has shown resistance to treatment, has relapsed, or shows measurable residual disease (at least 0.01% of cancer cells in bone marrow). Participants must have undergone at least two cycles of chemotherapy and have a performance status of 2 or less on the ECOG scale, meaning they can perform most daily activities. Adequate organ function is required, including liver enzymes less than 4 times the normal limit, heart ejection fraction greater than 40%, oxygen saturation above 92% without supplemental oxygen, and kidney function with creatinine clearance greater than 30 ml/min. Women of childbearing age must have a negative pregnancy test, and all participants capable of having children must use contraception for 12 months after treatment.
Who cannot participate: Individuals who are not adults, those who are pregnant or breastfeeding, patients with other serious health conditions that could interfere with the study, those who have participated in another clinical trial recently, or those who have received certain recent treatments that could affect study results.
Main focus: The study evaluates the safety and effectiveness of anti-CD19 CAR T cells in achieving remission and understanding how long treatment benefits last. After confirming eligibility and obtaining informed consent, patients undergo preparation to ensure satisfactory organ function. A single dose of CAR T-cells is infused, followed by close monitoring for 12 weeks for side effects including cytokine release syndrome, neurological events, infections, and febrile neutropenia. Follow-up assessments occur at 1, 3, 6, 12, 18, and 24 months to evaluate disease status, treatment response, progression-free survival, and overall survival.
Investigational drug: Anti-CD19 CAR T Cells (tisagenlecleucel), which are genetically modified T cells designed to target cancer cells expressing the CD19 protein.
Study on Adding Blinatumomab to Treatment for Adults with Precursor B-Acute Lymphoblastic Leukemia
This trial, conducted in Belgium and the Netherlands, is testing whether adding blinatumomab to standard treatment improves outcomes for adults with Precursor B-acute lymphoblastic leukemia. Blinatumomab is a special protein that helps the body’s immune system target and fight cancer cells.
Who can participate: Adults aged 18 to 70 years with Precursor B-acute lymphoblastic leukemia, including Philadelphia positive/BCR-ABL positive ALL and CD19 positive mixed phenotype acute lymphoblastic leukemia. Participants must have a WHO performance status of 0 to 2, meaning they can perform most daily activities with minimal limitations. Those capable of becoming pregnant must have a negative pregnancy test before joining. Written informed consent is required.
Who cannot participate: Patients with other types of cancer besides the specified types, those who have not achieved an MRD (Minimal Residual Disease) negative response after the first consolidation phase, individuals outside the specified age range, and those not meeting other study criteria.
Main focus: The study aims to determine how many patients achieve a state where minimal residual disease is not detectable after the first consolidation phase of treatment. Blinatumomab is given through an intravenous infusion during the early treatment phase and again during consolidation therapy. The trial follows a structured timeline including prephase therapy, two consolidation phases with blinatumomab, and regular follow-up appointments to monitor health status and detect any potential relapse. The study tracks overall survival and event-free survival, which measures the time without cancer progression or recurrence.
Investigational drug: Blinatumomab, a bispecific T-cell engager that helps the immune system recognize and attack cancer cells. It is administered intravenously.
Summary
These three clinical trials represent important advances in treating B Precursor Type Acute Leukaemia, particularly for patients whose disease has not responded to standard treatments or has returned after initial therapy. Two of the trials focus on CAR T-cell therapies, which involve modifying a patient’s own immune cells to attack cancer, while the third examines adding an immunotherapy drug to standard treatment protocols.
Geographically, the trials are distributed across Northern and Central Europe, with Denmark and Poland each hosting individual CAR T-cell therapy studies, and Belgium and the Netherlands jointly conducting the blinatumomab study. All three trials require adequate organ function and impose age restrictions, with most targeting adult populations. A common theme across all trials is the need for participants capable of having children to use effective contraception for an extended period after treatment.
The CAR T-cell trials both target the CD19 protein on cancer cells and involve similar processes of cell collection, modification, and reinfusion, though they use different specific treatments (CLIC-1901 and tisagenlecleucel). These studies highlight the growing importance of personalized cell-based therapies in treating blood cancers. Patients interested in participating should discuss eligibility with their healthcare team, as these trials offer access to cutting-edge treatments not yet widely available outside of research settings.
