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Acute lymphocytic leukaemia – Trials in Disease

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Ongoing Clinical Trials for Acute Lymphocytic Leukaemia

There are currently 35 clinical trials investigating new treatments for acute lymphocytic leukaemia across multiple countries in Europe and beyond. These studies are exploring innovative therapies including CAR T-cell treatments, targeted medications, immunotherapies, and chemotherapy combinations for patients of all ages with this blood cancer. (Also known as: Acute Lymphoblastic Leukemia, ALL)

Clinical trial locations

Long-term Safety Study of AUTO4 and Rituximab in Patients with Potential Malignancy Treated with Autologous CAR T Cell Therapy

This study focuses on monitoring patients who have previously received CAR T cell therapy, a treatment that modifies a person’s own immune cells to fight cancer. The trial is specifically designed for long-term safety follow-up over a period of up to 15 years after the initial treatment. Patients must have previously received AUTO CAR T cell therapy and have provided informed consent to participate in this long-term monitoring study.

The main purpose is to track serious side effects related to the CAR T cell therapy, particularly the development of new cancers and other significant health events. Throughout the study, researchers will monitor participants for remaining genetic material from the therapy in their blood and investigate any potential causes of new cancers. The trial excludes patients who develop potential malignancies after Autolus CAR T cell therapy treatment.

The investigational treatment involves Autologous T Cells Genetically Modified with Viral Vectors. These are immune cells collected from the patient, modified in a laboratory using viral vectors to introduce new genetic material, and designed to recognize and attack cancer cells or diseased cells in the body. The study will assess the long-term safety profile of this innovative therapy approach.

Study Comparing Inotuzumab Ozogamicin to Drug Combination for Children with High-Risk Relapsed B-cell Acute Lymphoblastic Leukemia

This trial is testing treatments for children with B-cell precursor acute lymphoblastic leukemia who have experienced a high-risk first relapse. The study compares Inotuzumab Ozogamicin, a targeted medication, with the standard ALLR3 treatment regimen to determine which approach is more effective in achieving minimal residual disease-negative status, meaning no cancer cells are detectable in the blood.

Participants must be between 1 and less than 18 years old at diagnosis and meet specific health criteria, including adequate kidney and liver function. The study is designed to include children who have certain types of relapse patterns and whose cancer cells express the CD19 or CD22 markers. Patients are excluded if they have cancer types other than the one being studied or are not within the specified age range.

Inotuzumab Ozogamicin is the main investigational medication, administered through intravenous infusion. It works by targeting specific proteins on cancer cells, helping the immune system destroy these cells. Other medications used in the trial include Dexamethasone, Pegaspargase, Vincristine Sulfate, and Mitoxantrone Hydrochloride. The study will monitor response rates, time to disease progression, duration of treatment response, and overall survival.

Study of CD19-CAR_Lenti, Fludarabine, and Cyclophosphamide in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia or Aggressive B-Cell Lymphomas

This clinical trial investigates a CAR T-cell therapy called CD19-CAR_Lenti for pediatric patients whose leukemia or lymphoma has not responded to treatment or has returned. The treatment uses specially modified T cells that are engineered to express a receptor targeting the CD19 protein found on certain cancer cells. These modified cells are administered through intravenous infusion after the body is prepared with chemotherapy medications.

Eligible participants must have CD19-expressing B acute lymphoblastic leukemia or specific types of lymphoma (diffuse large B-cell lymphoma or primary mediastinal lymphoma). They must be in complete remission before transplant and provide written informed consent. The study includes various age groups, from children to young adults, and requires patients to have adequate physical functioning and no previous stem cell transplants.

The treatment involves a conditioning regimen with Fludarabine Phosphate and Cyclophosphamide given intravenously before the CD19-CAR_Lenti infusion. These conditioning medications help prepare the body to receive the modified cells. The study will monitor participants for treatment response, side effects, and the persistence of modified cells in the body. The goal is to determine the safety and effectiveness of this approach in achieving complete remission.

Study of Dasatinib and Venetoclax for Children with Relapsed or Refractory Leukemia or Lymphoma with MAPK/SRC Pathway Mutation

This trial is testing two medications, Venetoclax and Dasatinib, for children whose leukemia or lymphoma has returned or not responded to treatment. The study focuses on patients with specific genetic changes in their cancer cells related to the MAPK/SRC signaling pathway, which is a series of protein interactions that can lead to cancer growth. Both medications are taken orally, either as tablets or liquid suspensions.

Children between 1 and 21 years old are eligible if they have been diagnosed with specific types of leukemia or lymphoblastic lymphoma that meet certain genetic criteria. They must have a performance status indicating they can perform daily activities with some limitations and adequate organ function. The study is divided into two phases: the first determines the safest dose, and the second evaluates how well the medications work.

Venetoclax and Dasatinib both target specific proteins involved in cancer cell growth. Venetoclax is available as an oral suspension and tablets, while Dasatinib comes as tablets and powder for oral suspension. Participants will receive either one medication or a combination of both, with regular monitoring to assess response and manage side effects. The trial aims to provide new treatment options for children with limited alternatives.

Study of Inotuzumab Ozogamicin and drug combination in adult patients with B-cell Acute Lymphoblastic Leukemia who have minimal residual disease before stem cell transplantation

This study examines the effectiveness of Inotuzumab Ozogamicin (Besponsa) in adult patients with B-cell acute lymphoblastic leukemia who have small numbers of remaining cancer cells (minimal residual disease) before receiving a stem cell transplant. The medication is administered through intravenous infusion, with participants potentially receiving up to two treatment courses depending on their response.

Eligible participants must be 18 years or older with B-cell lymphoblastic leukemia, having more than 20% cancer cells at initial diagnosis and CD22-positive cells. Patients must be in first or second complete remission with less than 5% cancer cells in bone marrow, have normal liver and pancreas function, and a life expectancy exceeding 12 weeks. Women of childbearing potential must have negative pregnancy tests and use effective contraception.

The treatment plan includes Inotuzumab ozogamicin as the primary medication, with potential additional medications such as Cyclophosphamide, Methotrexate, Prednisone, Ponatinib, Vincristine, and Mercaptopurine. The study monitors minimal residual disease levels after each treatment course and tracks participants for up to 2 years. The goal is to eliminate remaining cancer cells before transplantation, improving outcomes for patients with this challenging condition.

Study of Ponatinib and Chemotherapy for Adults with Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

This trial investigates Ponatinib, a tyrosine kinase inhibitor, in combination with various chemotherapy drugs for treating Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia, specifically a subtype known as BCR/ABL1-like ALL. The study aims to improve remission rates in patients with this specific genetic profile who have not responded well to standard treatments.

Eligible participants must be between 18 and 65 years old with a WHO score of 2 or less, indicating they can perform daily activities with some help. They must have newly diagnosed BCR/ABL1-like ALL with adequate liver and pancreas function. Patients should not have history of abnormal cholesterol levels, blood clots, or heart problems. Both men and women must agree to use effective birth control during the study and for 12 months afterward.

The treatment involves taking Ponatinib orally in tablet form along with multiple chemotherapy drugs including Dexamethasone, Vincristine Sulfate, Mercaptopurine, and others. These medications are administered through various routes including intravenous infusion and oral tablets. The study monitors participants to assess how many achieve minimal residual disease negativity, meaning no detectable cancer cells at a detailed level, and tracks overall survival rates and disease progression.

Study of Ruxolitinib and Venetoclax for Children with Relapsed or Refractory Leukemia or Lymphoma with IL-7R/JAK-STAT Pathway Mutations

This clinical trial tests two medications, Venetoclax and Ruxolitinib, for children whose leukemia or lymphoblastic lymphoma has returned or not responded to previous treatments. The study specifically targets patients with genetic changes in the IL-7R/JAK-STAT signaling pathway, which affects how cells communicate and can influence cancer growth. Both medications are administered orally as tablets or suspensions.

Children between 1 and 21 years old are eligible if they can swallow tablets and meet weight requirements (at least 26 kg for those under 6 years, and 33 kg for those over 6 years). They must have adequate organ function and specific genetic changes in their tumor cells. The study requires written consent from parents or guardians and, when appropriate, from the patient. Previous molecular testing of the disease is necessary to identify the targeted genetic alterations.

The trial is divided into two phases: Phase I determines the safest dose, while Phase II evaluates effectiveness. Participants will receive either Venetoclax, Ruxolitinib, or a combination of both, depending on their specific cancer type and genetic profile. The study closely monitors patients for side effects and treatment response, with regular assessments scheduled throughout the trial period, which continues until 2031.

Study on Allogeneic Stem Cell Transplantation for Children and Adolescents with Acute Lymphoblastic Leukemia Using Etoposide, Treosulfan, and Thiotepa

This trial studies different conditioning treatments used before stem cell transplantation in children and adolescents with acute lymphoblastic leukemia. Conditioning treatments help prepare the body to receive new stem cells. The study compares treatment that includes Total Body Irradiation (TBI) and Etoposide with alternative treatments using combinations of Fludarabine Phosphate, Thiotepa, Busulfan, and Treosulfan without TBI.

Eligible participants must have acute lymphoblastic leukemia or certain types of mixed phenotype acute leukemia, be 18 years or younger at diagnosis, and in complete remission before transplant. They must not have had previous stem cell transplants and must provide written informed consent. The study is conducted at participating centers across multiple European countries. Patients must have a medical reason for allogeneic stem cell transplantation and meet specific health criteria.

The treatment involves receiving conditioning medications through intravenous infusion, including options like etoposide, treosulfan, thiotepa, cyclophosphamide, busulfan, blinatumomab, and fludarabine phosphate. Different medication combinations are used depending on whether the donor is a perfect match or not. Following conditioning, patients receive the stem cell transplant, and are then closely monitored for response and any side effects. The study aims to determine which treatment approach provides the best outcomes while minimizing long-term side effects.

Study on Blinatumomab, Ponatinib, and Isatuximab for Adults Aged 18-65 with Newly Diagnosed Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma

This trial tests treatments for adults aged 18-65 with newly diagnosed acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. The study involves several medications: blinatumomab (an immunotherapy that helps the immune system target cancer cells), isatuximab (another immunotherapy targeting specific cancer cell markers), and ponatinib (a medication that blocks proteins involved in cancer cell growth). Some participants may also undergo stem cell transplantation.

Patients must be between 18 and 65 years old with specific types of leukemia classified as Ph-positive or Ph-negative B-ALL, or T-ALL. They should have an ECOG performance status of 2 or less, meaning they can carry out most daily activities. Participants must have adequate organ function and agree to use effective contraception. The study requires written informed consent and specific testing to classify the disease type before enrollment.

Treatment involves administering blinatumomab through intravenous infusion, with dosage and frequency determined by the study team. Patients in the Ph-positive B-ALL group also receive ponatinib as oral tablets. Those in the T-ALL group receive isatuximab as an infusion. Throughout the trial, patients undergo regular check-ups to monitor response to treatment, with blood tests and evaluations to assess health status and medication effectiveness. The study aims to improve outcomes for patients with these challenging types of blood cancer.

Study on Bortezomib and Drug Combination for Children with High-Risk Relapsed Acute Lymphoblastic Leukemia (ALL)

This trial studies treatments for children with high-risk relapsed acute lymphoblastic leukemia, comparing standard chemotherapy with and without the addition of Bortezomib. Bortezomib is being tested for its potential to enhance treatment results when combined with standard chemotherapy regimens. The study aims to improve outcomes for children whose leukemia has returned after initial treatment.

Eligible participants must be under 18 years old with confirmed diagnosis of first relapsed precursor B-cell or T-cell ALL meeting high-risk criteria. This includes specific relapse patterns and genetic characteristics. Patients must be enrolled at participating centers, have written informed consent, and begin treatment during the study period. They cannot be participating in other clinical trials 30 days before joining unless those trials are for primary ALL.

The medications used include Methotrexate, Dexamethasone, Mitoxantrone, Pegaspargase, Vincristine Sulfate, and Bortezomib, administered through injections or infusions directly into the bloodstream. Bortezomib works by interfering with cancer cell growth, potentially helping to stop or slow disease progression. The study monitors participants to assess complete remission rates, survival without cancer return, and overall survival, with regular health assessments throughout the treatment period that extends until 2028.

Summary

The 35 clinical trials for acute lymphocytic leukaemia reveal several important patterns in current research directions. A significant concentration of trials is testing CAR T-cell therapies, with multiple studies investigating treatments like AUTO1, CART 19/22, MB-CART2219.1, and tisagenlecleucel. These innovative immunotherapies represent a major focus in developing new treatment options for relapsed or refractory disease.

Another notable trend is the emphasis on targeted medications for patients with specific genetic markers. Several trials focus on Philadelphia chromosome-positive disease, testing tyrosine kinase inhibitors like ponatinib, imatinib, and dasatinib, often in combination with chemotherapy or immunotherapy. Studies are also investigating treatments for patients with particular pathway mutations, including MAPK/SRC, JAK-STAT, and BCR-ABL1-like profiles, representing a move toward more personalized medicine approaches.

Geographically, trials are predominantly concentrated in Western European countries, particularly Italy, Germany, France, Spain, Belgium, Austria, and the Netherlands. The Nordic countries (Sweden, Finland, Norway, Denmark) also host multiple trials. This concentration suggests strong research infrastructure and collaborative networks in these regions. Many trials operate across multiple countries, indicating significant international cooperation in leukemia research.

The trials span all age groups, from infants under one year to adults up to 75 years, though there is particular emphasis on pediatric populations. Several studies specifically target children and adolescents with relapsed or refractory disease, reflecting the significant unmet need in this patient group. Some trials focus on elderly patients (55+), addressing the unique challenges of treating older adults.

Immunotherapy approaches feature prominently, with multiple trials testing medications like blinatumomab (a bispecific T-cell engager), inotuzumab ozogamicin (an antibody-drug conjugate), and various combinations with chemotherapy. Studies are also investigating stem cell transplantation protocols with different conditioning regimens, comparing approaches with and without total body irradiation.

Ongoing Clinical Trials on Acute lymphocytic leukaemia

  • Study of TranspoCART19 cell therapy for patients with CD19-positive acute lymphoblastic leukemia that is resistant or refractory to treatment

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of olverembatinib with chemotherapy versus standard therapy in adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Hungary Italy Romania +1

  • Study on MB-CART2219.1 for Adults and Children with Relapsed or Refractory B-cell Malignancies

    Recruiting

    1 1
    Investigated diseases:
    Germany

  • Study on Pegaspargase for Treating Acute Lymphoblastic Leukemia in Children and Adolescents

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of CD19-CAR_Lenti, Fludarabine, and Cyclophosphamide in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia or Aggressive B-Cell Lymphomas

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of CARCIK-CD19 Cells for Patients with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Rapcabtagene Autoleucel and Ibrutinib for Adults with Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Other Blood Cancers

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Italy Spain

  • Study on Nivolumab and Tisagenlecleucel for Children, Adolescents, and Young Adults with Acute Lymphoblastic Leukemia After Treatment Loss

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Venetoclax and Blinatumomab for Adults with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

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