Ongoing Clinical Trials for Acute Lymphocytic Leukaemia Recurrent
This article provides information about 5 ongoing clinical trials exploring new treatments for acute lymphocytic leukaemia that has returned after previous treatment. These studies are testing innovative cell therapies and targeted medications that aim to improve outcomes for children and adults with relapsed disease. Trials are taking place across multiple European countries, offering patients access to cutting-edge experimental treatments.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Finland
- France
- Germany
- Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or B-Cell Malignancies
- Study on CD19+ Lymphoid Disease Using Genetically Modified T Cells for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin’s Lymphoma
- Study of Inotuzumab Ozogamicin Alone and with Drug Combination for Children with Relapsed or Refractory Acute Lymphoblastic Leukemia
- Greece
- Ireland
- Italy
- Netherlands
- Norway
- Spain
- Sweden
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 monitoring of patients who have previously received innovative cell therapies called CAR T-cell treatments. These therapies involve modifying a patient’s own immune cells to better recognize and attack cancer cells.
Who can participate: Adults and children who received Miltenyi CAR T-cell therapy at least 12 months ago are eligible. This includes patients treated for relapsed or refractory B-cell cancers such as acute lymphoblastic leukemia, non-Hodgkin lymphoma, and chronic lymphocytic leukemia. Participants must provide informed consent and be willing to attend regular follow-up visits.
Who cannot participate: The trial excludes patients with unspecified cancer types, those who haven’t experienced disease relapse or progression, patients lacking specific CD19 or CD20 markers on their cancer cells, those currently pregnant or breastfeeding, and individuals participating in other clinical trials.
Study focus: The main goal is to evaluate the long-term safety of these cell therapies. Researchers will monitor participants for any late-onset side effects, new health problems, or cancer recurrence. The study will track immune cell counts, growth and development in children, and check for the presence of modified cells from the original treatment. This comprehensive follow-up will continue until 2040, providing valuable insights into the lasting effects of these treatments.
Investigational treatment: The study monitors the long-term effects of Miltenyi CAR T-cell therapy, which uses genetically modified immune cells that were previously infused into patients to fight their cancer.
Study of DDCART-CD19 cells with cyclophosphamide and fludarabine for children and young adults (up to 39 years) with recurrent acute leukemia after stem cell transplant
This trial in Greece is testing a new approach for patients whose leukemia has returned after receiving a stem cell transplant. The treatment uses immune cells from the original stem cell donor, which are modified in the laboratory to target cancer cells more effectively.
Who can participate: Children and young adults aged 6 months to 39 years with CD19-positive acute leukemia that has relapsed after a donor stem cell transplant are eligible. Participants must have at least 0.05% leukemia cells in their bone marrow or disease outside the bone marrow. They should not have active graft-versus-host disease and must have adequate physical function. The original stem cell donor must be available for cell collection.
Who cannot participate: Patients with active uncontrolled infections, those requiring treatment for graft-versus-host disease, individuals with severe heart, lung, kidney, or liver problems, those with other active cancers, pregnant or breastfeeding women, patients with central nervous system involvement, and those with HIV or active hepatitis cannot participate.
Study focus: The trial aims to determine how safe and effective DDCART-CD19 treatment is for this patient population. Researchers will monitor how well the modified cells work to eliminate leukemia cells and how long patients remain in remission. The study will track participants for two years after treatment to assess long-term outcomes.
Investigational treatment: DDCART-CD19 is a CAR T-cell therapy using donor immune cells modified to target CD19 on cancer cells. Before receiving these cells, patients undergo preparation treatment with cyclophosphamide and fludarabine phosphate given intravenously.
Study on CD19+ Lymphoid Disease Using Genetically Modified T Cells for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin’s Lymphoma
This German trial is investigating a treatment that modifies patients’ own immune cells to fight blood cancers that have returned or not responded to previous treatments.
Who can participate: Adults aged 18 and older with CD19-positive acute lymphoblastic leukemia, chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma that has relapsed or proven resistant to treatment are eligible. Children and teenagers over 3 years old with CD19-positive acute lymphoblastic leukemia may also participate. Patients must have measurable disease, adequate kidney function, sufficient lymphocyte counts, and a life expectancy of at least 12 weeks for pediatric patients.
Who cannot participate: The study excludes patients with different cancer types than those specified, those whose cancer hasn’t relapsed or become resistant to treatment, and individuals outside the specified age ranges.
Study focus: The trial aims to establish the safety and effectiveness of CD19.CAR T-cell therapy for these challenging blood cancers. Researchers will gradually increase the dose to find the optimal amount and monitor how well the treatment reduces cancer burden. The study will assess how long modified cells survive in the body, overall survival rates, and duration of response.
Investigational treatment: The trial uses RV-SFG.CD19.CD28.4-BBzeta retroviral vector to modify T-cells, creating CD19.CAR T cells that specifically target cancer cells displaying CD19. These modified cells are infused back into patients intravenously.
Study of Inotuzumab Ozogamicin Alone and with Drug Combination for Children with Relapsed or Refractory Acute Lymphoblastic Leukemia
This large international trial spanning 13 European countries is testing a targeted therapy for children whose leukemia has returned or hasn’t responded to previous treatments.
Who can participate: Children aged 1 to 18 years with CD22-positive B-cell precursor acute lymphoblastic leukemia that has relapsed or is refractory to treatment are eligible. Participants must have a certain level of cancer cells in their bone marrow, adequate physical activity levels, and an expected survival of at least 6 weeks. They must have recovered from previous treatment side effects and demonstrate normal kidney, liver, and heart function. Female participants of childbearing age must have a negative pregnancy test and agree to use effective contraception.
Who cannot participate: Children without CD22-positive markers on their cancer cells, those who haven’t experienced relapse or whose disease isn’t treatment-resistant, patients outside the age range, those who received a bone marrow transplant during first complete remission, and patients unable to tolerate the study medication cannot participate.
Study focus: The trial aims to determine the best dose of inotuzumab ozogamicin for children and evaluate how effective it is both alone and combined with chemotherapy. Researchers will closely monitor treatment response and side effects throughout several treatment cycles. The study will provide important information about this targeted therapy’s potential for treating difficult-to-treat childhood leukemia cases.
Investigational treatment: Inotuzumab ozogamicin is an antibody-drug conjugate that targets the CD22 protein on cancer cells, delivering a toxic agent directly to them. It’s administered intravenously, either alone or with chemotherapy.
Study on Tisagenlecleucel for High-Risk B-Cell Acute Lymphoblastic Leukemia in Pediatric and Young Adult Patients with Minimal Residual Disease
This trial across 8 European countries is evaluating CAR T-cell therapy for high-risk pediatric and young adult patients who still have small amounts of cancer remaining after initial treatment.
Who can participate: Patients aged 1 to 25 years with CD19-positive B-cell acute lymphoblastic leukemia classified as high-risk are eligible. They must have been diagnosed with new-onset disease, received first-line treatment, and still have minimal residual disease of 0.01% or higher at the end of the first treatment phase. Participants must have a performance status of at least 60% on age-appropriate scales and adequate kidney, liver, lung, and heart function. They must be suitable for a cell collection procedure called leukapheresis.
Who cannot participate: Specific exclusion criteria are not detailed in the provided information, but generally would include patients who don’t meet the inclusion requirements.
Study focus: The trial aims to evaluate whether tisagenlecleucel can improve overall survival and disease-free survival in high-risk patients with minimal residual disease. The study will compare outcomes between those receiving tisagenlecleucel and those who don’t, monitoring patients over an extended period to assess long-term treatment effects and safety.
Investigational treatment: Tisagenlecleucel is a CAR T-cell therapy that modifies patients’ own T-cells to recognize and attack cancer cells. Before receiving the infusion, patients undergo preparation treatment with cyclophosphamide and fludarabine phosphate to create an optimal environment for the therapy to work.
Summary
These five ongoing clinical trials represent the current landscape of research for recurrent acute lymphocytic leukemia in Europe. A notable pattern emerges in the concentration of trials across Western and Northern European countries, with Germany, France, Belgium, the Netherlands, and Scandinavian nations participating in multiple studies. The inotuzumab ozogamicin trial has the broadest geographic reach, spanning 13 countries.
Four of the five trials focus specifically on pediatric populations or include young adults, highlighting the particular need for treatment options in these age groups. Three studies investigate various forms of CAR T-cell therapy, representing a major focus in current research for this condition. These innovative treatments modify patients’ own immune cells or use donor cells to target cancer more effectively.
The trials range from early-phase dose-finding studies to long-term safety monitoring, providing a comprehensive research approach. Some studies test single agents while others combine treatments with chemotherapy, exploring different therapeutic strategies. Most trials specifically target CD19 or CD22 proteins found on cancer cells, reflecting the importance of these markers in treatment development.
Patients interested in participating should discuss these options with their healthcare providers, considering factors such as age eligibility, disease characteristics, previous treatments received, and geographic location. Each trial has specific requirements regarding disease markers, organ function, and prior therapy that must be carefully evaluated.
