In short
Three clinical trials are currently recruiting patients with leukaemia across Europe. These studies explore new treatment approaches for specific types of blood cancers, including trials for patients undergoing stem cell transplantation and for children with Philadelphia chromosome-positive leukaemia. The trials are taking place in Germany, France, and Spain.
Clinical trial locations
- France
- Germany
- Spain
Study on the Safety and Effectiveness of Venetoclax with Fludarabine, Amsacrine, and Cytarabine for Patients with MDS, CMML, or Secondary AML Undergoing Stem Cell Transplantation
This study is designed for adults aged 18 to 64 years with specific blood disorders: Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or Secondary Acute Myeloid Leukemia (sAML). MDS occurs when blood-forming cells in the bone marrow are damaged, leading to shortages of healthy blood cells. CMML is a cancer that starts in bone marrow cells and causes an increase in monocytes, a type of white blood cell. Secondary AML develops from a previous blood disorder or after certain cancer treatments, causing rapid growth of abnormal white blood cells.
Inclusion criteria: Participants must have one of these three conditions with more than 5% immature blood cells (blasts) in their bone marrow. They must also have high-risk genetic features and fall into the "high" or "very high" risk category according to medical guidelines. Both men and women can participate.
Exclusion criteria: Patients who have already received a stem cell transplant cannot join. The study is only for those with the specific blood disorders mentioned and who are considered high-risk. Pregnant or breastfeeding women, those with other medical conditions that might interfere with treatment, and those participating in another clinical trial are also excluded.
Treatment approach: The trial tests Venetoclax, a medication taken orally as a tablet, in combination with other chemotherapy drugs: Fludarabine, Amsacrine, Cytarabine, and Treosulfan. Venetoclax works by blocking a protein called BCL-2 that helps cancer cells survive. The combination is given as a conditioning regimen to prepare the body before allogeneic blood stem cell transplantation, where healthy stem cells from a donor replace diseased bone marrow.
Study goal: The main purpose is to determine whether adding Venetoclax to the standard conditioning regimen is safe for patients undergoing stem cell transplantation. Researchers will monitor patients for side effects, organ toxicity, and complications for up to 100 days after transplantation, and continue long-term follow-up to assess disease response and survival outcomes.
Study on the Safety of ATreg Cells for Patients with Leukemia After Stem Cell Transplant to Reduce Graft vs Host Disease
This trial focuses on a complication that can occur after stem cell transplantation called Graft versus Host Disease (GvHD). In this condition, the transplanted immune cells attack the patient's own body tissues. The study tests a new treatment using special immune cells called GP120-activated regulatory T cells (ATreg) to prevent or reduce this complication.
Inclusion criteria: The study accepts adults aged 18 years and older of any gender who need a stem cell transplant. Participants must have a blood-related cancer such as acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, multiple myeloma, myeloproliferative disorders, or lymphoma. They must have a healthy donor available who is a good tissue match (9 out of 10 or 10 out of 10 HLA matches). Life expectancy must be more than 6 weeks.
Exclusion criteria: Pregnant or breastfeeding women cannot participate. Patients with other serious health conditions, recent major surgery, active infections requiring treatment, or a history of allergic reactions to similar treatments are excluded. Those currently participating in another clinical trial or with a history of drug or alcohol abuse are also not eligible.
Treatment approach: Participants receive ATreg cells through an infusion directly into the bloodstream. These are regulatory T cells that have been specially activated with a protein called GP120. The cells are prepared outside the body before being given to the patient.
Study goal: The primary aim is to assess how safe and tolerable the ATreg treatment is for patients after stem cell transplantation. Researchers will monitor for serious side effects at multiple time points: within 24 hours, at 3 days, 7 days, 14 days, and continuing through 6 months after treatment. The study will also track the incidence and severity of acute GvHD, infections, disease relapse, and overall survival.
Study of dasatinib treatment in children and adolescents with Philadelphia chromosome-positive leukemia who cannot take imatinib or for whom imatinib is not effective
This study is specifically designed for children and adolescents with Chronic Myeloid Leukemia (CML) and Philadelphia chromosome-positive leukemias. The Philadelphia chromosome is an abnormal genetic change found in these types of blood cancers. CML begins in the bone marrow and causes the body to produce too many white blood cells. The disease can progress through different phases, starting with a chronic phase where symptoms may be mild or absent.
Inclusion criteria: Children and adolescents aged 1 to 18 years can participate. The study includes three groups: patients with chronic phase CML who cannot tolerate or did not respond to imatinib treatment; patients with Philadelphia chromosome-positive ALL or advanced phase CML who cannot take imatinib; and newly diagnosed patients with chronic phase CML. Participants must have adequate organ function based on blood tests and a performance score above 50, indicating reasonable ability to perform daily activities. Life expectancy must be at least 12 weeks.
Exclusion criteria: Children who have previously been treated with BCR-ABL inhibitors other than imatinib cannot join. Those with a specific genetic mutation called T315I, which makes the cancer resistant to treatment, are excluded. Patients with active cancer involvement in the central nervous system, significant heart problems, severe liver or kidney problems, uncontrolled infections, or those who are pregnant or breastfeeding cannot participate.
Treatment approach: The study medication is dasatinib, available as tablets or as a powder that can be made into a liquid for oral administration. Dasatinib works by blocking specific proteins called tyrosine kinases that cause cancer cells to grow and divide. It is being tested as an alternative for patients whose cancer became resistant to imatinib or who experienced severe side effects from that medication.
Study goal: The trial aims to determine how well dasatinib works in young patients with Philadelphia chromosome-positive leukemias who cannot take imatinib. Researchers will monitor treatment response by tracking blood cell counts, measuring the reduction of cancer cells in bone marrow, and checking for the presence of the Philadelphia chromosome. The study will evaluate both the effectiveness of the medication and its safety in this younger age group.
Summary
Three clinical trials are currently recruiting patients with various forms of leukaemia across Europe. Two of the trials are being conducted in Germany, focusing on patients undergoing stem cell transplantation. One trial examines Venetoclax in combination with standard chemotherapy drugs for adults with high-risk blood disorders, while another investigates ATreg cells to reduce complications after transplantation. The third trial, taking place in both France and Spain, is dedicated to paediatric patients with Philadelphia chromosome-positive leukaemia who need an alternative to imatinib treatment.
These trials reflect different aspects of leukaemia treatment: improving conditioning regimens before transplantation, preventing post-transplant complications, and finding effective treatments for children with specific genetic forms of the disease. Germany appears to be a major hub for stem cell transplantation research in these studies. The trials investigate both novel immunotherapies like ATreg cells and targeted cancer medications like Venetoclax and dasatinib.
