Ongoing Clinical Trials for B-cell Type Acute Leukaemia
There are currently 8 clinical trials ongoing for B-cell type acute leukaemia, exploring innovative treatments including CAR T-cell therapies, targeted antibodies, and combination drug approaches. These trials are taking place across multiple European countries, offering hope to patients with relapsed or refractory disease who have limited treatment options.
Clinical trial locations
- Austria
- Belgium
- Croatia
- Czechia
- Denmark
- Finland
- France
- Long-Term Follow-Up Study for Patients Treated with CAR T-Cell Therapy Using PHE885, YTB323, and Tisagenlecleucel
- Study on the Safety and Effectiveness of AZD0486 and Tocilizumab for Adolescents and Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- Study of UCART22 for Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
- Study of SAR443579 Infusion for Adults and Children with Relapsed or Refractory Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia, HR-MDS, or BPDCN
- Study on the Safety and Effectiveness of Brexucabtagene Autoleucel for Children and Teens with Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
- Germany
- Long-Term Follow-Up Study for Patients Treated with CAR T-Cell Therapy Using PHE885, YTB323, and Tisagenlecleucel
- Study on the Safety and Effectiveness of AZD0486 and Tocilizumab for Adolescents and Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- Study of Venetoclax and Blinatumomab for Adults with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia
- Study on the Safety and Effectiveness of Brexucabtagene Autoleucel for Children and Teens with Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
- Greece
- Hungary
- Italy
- Long-Term Follow-Up Study for Patients Treated with CAR T-Cell Therapy Using PHE885, YTB323, and Tisagenlecleucel
- Study on CD19-CAR T Cells, Fludarabine, and Cyclophosphamide for Children and Young Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
- Study on the Safety and Effectiveness of AZD0486 and Tocilizumab for Adolescents and Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- Study of UCART22 for Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
- Study on the Safety and Effectiveness of Brexucabtagene Autoleucel for Children and Teens with Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
- Netherlands
- Norway
- Poland
- Slovenia
- Spain
- Long-Term Follow-Up Study for Patients Treated with CAR T-Cell Therapy Using PHE885, YTB323, and Tisagenlecleucel
- Study on the Safety and Effectiveness of AZD0486 and Tocilizumab for Adolescents and Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- Study of UCART22 for Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
- Study on the Safety and Effectiveness of Brexucabtagene Autoleucel for Children and Teens with Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
- Sweden
Long-Term Follow-Up Study for Patients Treated with CAR T-Cell Therapy Using PHE885, YTB323, and Tisagenlecleucel
This trial focuses on the long-term safety monitoring of patients who have previously received CAR T-cell therapy for various conditions. CAR T-cell therapy involves modifying a patient’s own immune cells to better recognize and attack cancer cells.
Inclusion criteria: Participants must have previously received CAR T-cell therapy as part of a Novartis or Penn sponsored trial or managed access program. Both adults and children can participate, and informed consent is required before joining.
Exclusion criteria: Patients who have been treated with Novartis or Penn CAR-T therapy for any reason cannot participate in this follow-up study.
Main focus: The primary goal is to observe and document any delayed side effects that may be related to previous CAR T-cell therapy. This includes monitoring for new cancers, serious infections, neurological disorders, autoimmune conditions, and blood disorders. Regular blood tests will track the presence of modified T-cells, and ongoing health assessments will monitor for disease relapse or progression.
Investigational drugs: The study involves three CAR T-cell products: PHE885, YTB323, and Tisagenlecleucel. All are administered through intravenous infusion and represent different approaches to targeting cancer cells through genetic modification of T-cells.
Study on CD19-CAR T Cells, Fludarabine, and Cyclophosphamide for Children and Young Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
This trial is testing a second-generation CAR T-cell therapy called CD19-CAR_Lenti_ALLO for children and young adults whose disease has returned or not responded to previous treatments.
Inclusion criteria: Participants must be between 1 and 35 years old with relapsed or refractory disease. They must have CD19-positive cells present and a fully matched related donor available. Previous CD19-directed therapy is acceptable if certain conditions are met, including the presence of CD19-positive cells and at least one month since the last treatment.
Exclusion criteria: The trial excludes patients with different types of cancer, those with severe allergic reactions to similar treatments, active uncontrolled infections, pregnant or breastfeeding individuals, serious heart conditions, and those currently in other clinical trials.
Main focus: The primary aim is to evaluate the safety of CD19-CAR_Lenti_ALLO and establish the recommended dose for patients. Before receiving the CAR T-cells, participants undergo lymphodepletion therapy with fludarabine and cyclophosphamide to prepare the body. The dosage of CAR T-cells depends on whether the donor is fully matched or haploidentical.
Investigational drugs: CD19-CAR T cells are specially modified immune cells taken from a donor and engineered to target the CD19 protein found on certain cancer cells. The therapy is delivered through intravenous infusion.
Study on the Safety and Effectiveness of AZD0486 and Tocilizumab for Adolescents and Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
This trial investigates AZD0486, a human monoclonal antibody that targets CD3 and CD19 proteins on cancer cells, along with tocilizumab for managing potential side effects.
Inclusion criteria: Participants must be between 16 and 80 years old for Part A, and between 12 and 80 years old for Parts B and C. They must have CD19-positive disease with at least 5% blasts in bone marrow, and have relapsed or refractory disease after at least two previous treatments. An ECOG Performance Status of 2 or less, or Lansky score of 50% or more is required.
Exclusion criteria: Patients with different cancer types, those outside the specified age ranges, pregnant or breastfeeding individuals, those with serious interfering health conditions, recent major surgery, active infections requiring treatment, known allergies to study drugs, and those in other clinical trials are excluded.
Main focus: The study aims to determine the safety and tolerability of AZD0486, as well as its effectiveness in treating relapsed or refractory disease. The trial is divided into parts focusing on different age groups and disease characteristics, with some participants receiving a placebo for comparison.
Investigational drugs: AZD0486 is administered through intravenous infusion. Tocilizumab may be given as additional treatment to manage specific symptoms or side effects.
Study of UCART22 for Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
This trial tests UCART22, a therapy using specially engineered T-cells designed to target the CD22 marker on cancer cells.
Inclusion criteria: Participants must be between 15 and 70 years old for dose escalation, or 12 to 70 years old for dose expansion. They must have relapsed or refractory disease after at least one standard chemotherapy and one additional treatment. At least 70% of cancer cells must show the CD22 protein. Adequate organ function is required, including kidney, liver, heart, and lung function meeting specific thresholds.
Exclusion criteria: Patients who have not experienced return or persistence of their disease, those who have not failed CD19-targeted treatment, individuals outside the specified age range, and those in vulnerable populations requiring special protection are excluded.
Main focus: The trial evaluates the safety and effectiveness of UCART22 in treating relapsed or refractory disease. The study is divided into dose-escalation and dose-expansion phases to find the safest and most effective dose. Additional medications including alemtuzumab, rituximab, cyclophosphamide, and fludarabine phosphate may be used to prepare the body for treatment.
Investigational drugs: UCART22 consists of engineered T-cells that recognize and attack cancer cells displaying the CD22 protein. The therapy is delivered through intravenous infusion.
Study on Pegaspargase and Rituximab for Treating Children with Acute Lymphoblastic Leukemia
This trial explores treatment strategies for childhood acute lymphoblastic leukemia using pegaspargase and rituximab to improve survival rates and reduce complications.
Inclusion criteria: Participants must be between 1 and less than 18 years old at diagnosis, with confirmed acute lymphoblastic leukemia according to study guidelines. They must start induction therapy between December 1, 2022, and December 31, 2028, at a participating medical center. Signed informed consent is required, and female patients who can have children must have a negative pregnancy test.
Exclusion criteria: Patients without a diagnosis of childhood non-mature-B acute lymphoblastic leukemia, those outside the specified age range, individuals not part of the specified clinical trial group, and those not considered part of the vulnerable population selected for the study cannot participate.
Main focus: The study evaluates the effectiveness of intensified treatment with pegaspargase and the impact of immunotherapy with rituximab for patients with B-cell precursor disease. Participants undergo induction therapy followed by close monitoring, with minimal residual disease status checked on day 33 and day 78 using flow cytometry.
Investigational drugs: Pegaspargase (Oncaspar) works by breaking down asparagine, a substance necessary for cancer cell growth. Rituximab (Riximyo) is an anti-CD20 immunotherapy that helps the immune system recognize and attack cancer cells. Both are administered through infusion.
Study of SAR443579 Infusion for Adults and Children with Relapsed or Refractory Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia, HR-MDS, or BPDCN
This trial investigates SAR443579 for treating several types of blood cancers, including B-cell acute lymphoblastic leukemia, acute myeloid leukemia, high-risk myelodysplastic syndrome, and blastic plasmacytoid dendritic cell neoplasm.
Inclusion criteria: Participants must be at least 1 year old, with adults being at least 12 years old and children between 1 and 17 years old. For the escalation part, participants must have confirmed diagnosis of acute myeloid leukemia meeting specific criteria, or B-cell acute lymphoblastic leukemia without disease outside the bone marrow. Body weight must be at least 10 kg.
Exclusion criteria: Excluded are patients with other cancer types not in the study, those with recent different cancer treatments, serious uncontrolled infections, significant heart problems, severe liver or kidney issues, pregnant or breastfeeding individuals, those unable to follow procedures, individuals with allergic reactions to similar treatments, and recent participants in other trials.
Main focus: The study aims to find the most suitable dose of SAR443579 and evaluate its effectiveness. It is divided into dose escalation and dose expansion phases, with participants closely monitored for side effects and treatment response through regular blood tests and health assessments.
Investigational drugs: SAR443579 is administered through intravenous infusion as a single agent, with the study evaluating both safety and anti-leukemic activity.
Study of Venetoclax and Blinatumomab for Adults with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia
This trial tests the combination of venetoclax and blinatumomab for adults whose disease has returned or not responded to previous treatments.
Inclusion criteria: Participants must be 18 years or older with an ECOG performance status of 2 or less. They must have Philadelphia negative, CD19-positive disease with specific molecular markers available. A positive minimal residual disease marker greater than 0.01% is required if in first or second remission. Women who can become pregnant must have a negative pregnancy test and use effective birth control. Participation in the German Multicenter Study Group for Adult ALL registry is required.
Exclusion criteria: Excluded are patients with different cancer types, those outside the specified age range, pregnant or breastfeeding individuals, those with serious interfering medical conditions, current participants in other trials, individuals with recent major surgery, active infections requiring treatment, known allergies to study drugs, and those with certain heart conditions.
Main focus: The trial is divided into two phases. Phase I focuses on determining feasibility, safety, and tolerability while establishing the maximum tolerated dose. Phase II evaluates patient response to the combination treatment. Venetoclax is taken orally as tablets, while blinatumomab is given through intravenous infusion.
Investigational drugs: Venetoclax works by blocking a protein called BCL-2 that helps cancer cells survive, thereby promoting their death. Blinatumomab is an immunotherapy that connects immune cells to cancer cells, allowing the immune system to attack cancer more effectively.
Study on the Safety and Effectiveness of Brexucabtagene Autoleucel for Children and Teens with Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
This trial evaluates KTE-X19, a cell therapy using modified immune cells to fight relapsed or refractory disease in children and adolescents.
Inclusion criteria: Participants must be under 18 years old and weigh at least 6 kg. They must have relapsed or refractory B-precursor acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma, confirmed by histology for lymphoma. Previous treatments must include anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy. A Lansky or Karnofsky score of 80 or higher is required, along with adequate kidney, liver, lung, and heart function. For acute lymphoblastic leukemia, a certain amount of cancer cells in bone marrow or positive minimal residual disease is required.
Exclusion criteria: Excluded are patients with different cancer types, those who have not experienced return or resistance of their cancer, individuals outside the specified age range, those unable to follow procedures or attend visits, individuals with serious interfering health conditions, pregnant or breastfeeding individuals, those with recent interfering treatments, individuals with allergies to study medication, and current participants in other trials.
Main focus: The study evaluates the safety and effectiveness of KTE-X19 in achieving remission, divided into safety assessment and efficacy determination phases. Participants receive treatment through intravenous infusion and are closely monitored for side effects and treatment response, including duration of remission and overall survival rates.
Investigational drugs: KTE-X19 (brexucabtagene autoleucel) is a CAR T-cell therapy where the patient’s own T-cells are modified to better recognize and attack cancer cells, then infused back into the patient.
Summary
The landscape of clinical trials for B-cell type acute leukaemia demonstrates significant innovation in treatment approaches. A notable concentration of trials is taking place across Europe, with France, Germany, Italy, and Spain hosting multiple studies. This geographic distribution provides access to experimental treatments for patients across the continent.
CAR T-cell therapies dominate the research focus, with several trials testing different approaches to engineering immune cells to fight cancer. These include trials focusing on CD19-targeting, CD22-targeting, and combination approaches. The presence of a long-term follow-up study spanning 12 countries highlights the importance of understanding the lasting effects of these innovative therapies.
Several trials specifically address pediatric and young adult populations, recognizing that treatment approaches may differ from those used in older adults. The age ranges vary considerably across studies, from as young as 1 year old to adults up to 80 years, reflecting the disease’s impact across the lifespan.
The trials employ various therapeutic strategies beyond CAR T-cells, including monoclonal antibodies, combination chemotherapy approaches, and targeted therapies. This diversity suggests an active search for the most effective treatment options for patients whose disease has not responded to standard therapies or has returned after initial treatment.
