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Ongoing Clinical Trials for Chronic Lymphocytic Leukaemia

This article provides detailed information about ongoing clinical trials for Chronic Lymphocytic Leukaemia. These studies are testing various treatment approaches including new medications, combination therapies, and innovative treatment strategies for patients at different stages of the disease. A total of 60 clinical trials are currently active across multiple European countries, offering patients access to cutting-edge treatments and contributing to advances in leukaemia care.

Clinical trial locations

Efficacy and Safety of Three Different Doses of Pirtobrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Previously Received BTK Inhibitor Treatment

This study tests a treatment for patients whose chronic lymphocytic leukaemia or small lymphocytic lymphoma has returned or stopped responding to previous treatments that included a BTK inhibitor medication. Participants will be randomly assigned to receive one of three different doses of pirtobrutinib tablets taken by mouth. The trial aims to find the best dose and understand how safe and effective the medication is in controlling the disease.

Main inclusion criteria: Participants must have CLL or SLL confirmed by medical tests and have previously received between 1 and 3 treatment regimens. The disease must require treatment according to medical guidelines. Patients need adequate blood counts and organ function, with an ECOG performance status between 0 and 2.

Main exclusion criteria: Patients who have recently received cancer treatments within 3 weeks, those who have had a stem cell transplant within 60 days, people with active serious infections, certain heart conditions or recent cardiovascular events, severe liver problems, and pregnant or breastfeeding women cannot participate.

Trial focus: The study compares three different doses of pirtobrutinib (60 mg, 120 mg, and 200 mg) to determine which is most effective and safe for treating relapsed or refractory CLL/SLL in patients who have previously received BTK inhibitor therapy.

Investigational drug: Pirtobrutinib blocks a specific protein in cancer cells that helps them survive, thereby slowing down or stopping disease progression in patients with CLL or SLL who have already tried other treatments.

Long-Term Safety Study of BCMACP03, BCN-CP01, and 19CP02 for Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, CLL, SLL, or Multiple Myeloma

This long-term follow-up study monitors patients who have previously received CAR T-cell therapy for blood cancers including chronic lymphocytic leukaemia, small lymphocytic lymphoma, or multiple myeloma. The study aims to track the safety of these treatments for up to 15 years after infusion, observing for any long-term side effects, disease progression, and overall survival.

Main inclusion criteria: Participants must have previously received GLPG CAR T-cell therapy in a clinical trial or managed access programme. Both men and women over 18 years old can participate, and they must provide written informed consent to follow the study protocol.

Main exclusion criteria: Patients who have not experienced disease progression after their CAR T-cell therapy are not eligible for this long-term follow-up study.

Trial focus: The study monitors participants over 15 years to assess long-term safety outcomes including adverse events, disease progression, survival rates, and the presence of CAR T-cells in the blood.

Investigational drug: GLPG CAR T-cell therapies use the patient’s own modified immune cells to target and destroy cancer cells, representing a personalised immunotherapy approach for treating blood cancers.

Safety Study of Sonrotoclax and Zanubrutinib for Patients with Untreated Chronic Lymphocytic Leukemia

This study investigates the safety of different ways to start treatment with sonrotoclax in adults who have not yet received treatment for chronic lymphocytic leukaemia. Participants will receive sonrotoclax tablets and zanubrutinib capsules orally, with the study focusing on monitoring for a condition called tumour lysis syndrome that can occur when cancer cells break down rapidly.

Main inclusion criteria: Participants must be at least 18 years old with CLL or SLL confirmed by medical tests and requiring treatment. They need adequate blood counts, kidney function (creatinine clearance above 30 mL/min), liver function, an ECOG performance status of 2 or less, and a life expectancy exceeding 2 years.

Main exclusion criteria: Patients with other types of cancer, serious heart problems, uncontrolled infections, pregnant or breastfeeding women, those with severe liver or kidney disease, recent major surgery, or recent participation in other clinical trials cannot join the study.

Trial focus: The study evaluates the safety of initiating sonrotoclax therapy using different ramp-up schedules, particularly monitoring for tumour lysis syndrome and optimising the treatment start for patients with untreated CLL.

Investigational drug: Sonrotoclax targets a specific protein that helps cancer cells survive, promoting their death and potentially improving outcomes for patients with chronic lymphocytic leukaemia when used with zanubrutinib.

Study Comparing BGB-16673 to Drug Combinations for Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Treated with BTK and BCL2 Inhibitors

This study compares a new treatment called BGB-16673 with other medication combinations for patients whose chronic lymphocytic leukaemia or small lymphocytic lymphoma has returned or not responded to previous treatments with BTK and BCL2 inhibitors. Participants will receive either BGB-16673 tablets or one of several combination therapies chosen by their doctor, with the study monitoring how long patients live without disease progression.

Main inclusion criteria: Participants must be at least 18 years old with confirmed CLL or SLL requiring treatment. They must have previously received both BTK and BCL2 inhibitor therapies, have adequate blood counts and organ function, an ECOG performance status of 0-2, and be willing to use effective birth control during the study.

Main exclusion criteria: Patients with different types of cancer, those unable to follow study procedures, people with other serious health conditions interfering with treatment, pregnant or breastfeeding women, recent participants in other trials, those with allergies to study medications, recent major surgeries, and those with certain heart, infection, or liver/kidney problems cannot participate.

Trial focus: The study evaluates whether BGB-16673 can improve progression-free survival compared to standard treatment combinations in patients with relapsed or refractory CLL/SLL who have previously received BTK and BCL2 inhibitor therapies.

Investigational drug: BGB-16673 represents a novel therapeutic approach being tested to determine if it offers better disease control compared to existing treatment combinations for patients with previously treated CLL or SLL.

Study Comparing Nemtabrutinib and Venetoclax with Venetoclax and Rituximab for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

This study compares two treatment combinations for patients whose chronic lymphocytic leukaemia or small lymphocytic lymphoma has returned or not responded to previous treatments. One group receives nemtabrutinib tablets with venetoclax tablets, while the other receives venetoclax tablets with rituximab infusions. The trial aims to determine which combination is more effective at preventing disease progression.

Main inclusion criteria: Participants must have confirmed CLL or SLL requiring treatment, be at least 18 years old, have adequate bone marrow and organ function, an ECOG performance status of 0-3, a life expectancy of at least 3 months, previous treatment with at least one regimen, and be able to swallow oral medication. Men capable of fathering children must use prescribed contraception.

Main exclusion criteria: Patients with other cancer types, recent heart attacks or severe heart problems, uncontrolled infections, pregnant or breastfeeding women, recent major surgery, active hepatitis B or C, HIV, and those participating in other clinical trials cannot join the study.

Trial focus: The study measures progression-free survival to determine which treatment combination – nemtabrutinib with venetoclax or venetoclax with rituximab – is more effective for patients with relapsed or refractory CLL/SLL.

Investigational drugs: Nemtabrutinib blocks proteins helping cancer cells grow, venetoclax promotes cancer cell death by targeting survival proteins, and rituximab helps the immune system recognise and destroy cancer cells, all working together to control the disease.

Study Comparing Nemtabrutinib, Ibrutinib, and Acalabrutinib for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This study compares three different medications – nemtabrutinib, ibrutinib, and acalabrutinib – all taken as oral tablets, for patients who have not yet received treatment for chronic lymphocytic leukaemia or small lymphocytic lymphoma. Participants will be randomly assigned to receive one of these treatments, with the study monitoring how well each medication works in controlling the disease and improving survival.

Main inclusion criteria: Participants must have confirmed CLL or SLL requiring treatment with active disease, at least one measurable sign of disease, an ECOG performance status of 0-2 within 7 days before starting, ability to swallow oral medication, and meet requirements for hepatitis B/C and HIV testing. Both males and females can participate if they meet criteria.

Main exclusion criteria: Patients who have already received treatment for CLL or SLL, those not in the specified age range, people not meeting other specified criteria, and those considered part of vulnerable populations cannot participate in this study.

Trial focus: The study compares the effectiveness of nemtabrutinib against ibrutinib and acalabrutinib by measuring progression-free survival and overall response rates in previously untreated patients with CLL or SLL.

Investigational drugs: Nemtabrutinib is being tested for its potential to treat CLL/SLL by inhibiting specific proteins in cancer cells, while ibrutinib and acalabrutinib serve as comparators, all working by targeting proteins that help cancer cells grow and survive.

Study of Ibrutinib for Treating Autoimmune Hemolytic Anemia in Patients with Chronic Lymphocytic Leukemia or Similar Conditions

This study tests ibrutinib capsules for treating autoimmune haemolytic anaemia in patients who have chronic lymphocytic leukaemia, small lymphocytic lymphoma, or CLL-like conditions. The trial aims to evaluate how effective ibrutinib is in treating AIHA over several treatment cycles, with each cycle lasting 28 days, monitoring response rates and safety throughout the study period.

Main inclusion criteria: Participants must have CLL, SLL, or CLL-like MBL according to guidelines, be over 18 years old, have active AIHA that has returned after steroid treatment or doesn’t respond to steroids, have adequate kidney and liver function, be able to swallow pills, and provide written informed consent. Women who can become pregnant must use birth control and have negative pregnancy tests.

Main exclusion criteria: Patients who do not have CLL, SLL, or CLL-like MBL cannot participate in this study.

Trial focus: The study evaluates ibrutinib’s effectiveness in treating autoimmune haemolytic anaemia in patients with CLL or related conditions over multiple 28-day treatment cycles, measuring response rates at 3, 6, and 12 cycles.

Investigational drug: Ibrutinib blocks a specific protein that helps cancer cells grow and survive, which may help improve the blood disorder autoimmune haemolytic anaemia in patients with CLL or related conditions.

Study of IDP-121 for Patients with Relapsed or Refractory Multiple Myeloma, B-cell Lymphoma, or Chronic Lymphocytic Leukemia

This study tests a new treatment called IDP-121 given as an infusion for patients whose chronic lymphocytic leukaemia, B-cell lymphomas, or multiple myeloma has returned or not responded to previous treatments. The trial has two phases: first finding the best dose patients can tolerate, then testing how well that dose works in treating these cancers.

Main inclusion criteria: Participants must be at least 18 years old, have an ECOG performance status of 2 or less (able to do self-care), a life expectancy of at least 3 months, be willing to follow study procedures, and have specific diagnoses of CLL, B-cell lymphomas, or multiple myeloma with no other available treatments expected to improve survival. They need adequate blood counts, kidney function, liver function, and heart function.

Main exclusion criteria: Patients with other serious health conditions interfering with the study, recent cancer in the past unless treated and cured, pregnant or breastfeeding women, active infections requiring treatment, recent heart attacks or strokes within 6 months, recent major surgery, organ transplants, and those currently in another clinical trial cannot participate.

Trial focus: The study has two phases – the dose-escalation phase determines the maximum tolerated dose of IDP-121, while the expansion phase evaluates the overall response rate at the recommended dose in patients with relapsed or refractory blood cancers.

Investigational drug: IDP-121 is being tested to find the best dose and evaluate its potential to treat patients with relapsed or refractory blood cancers including chronic lymphocytic leukaemia, B-cell lymphomas, and multiple myeloma.

Study of Lisaftoclax Alone or with Drug Combination for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This study tests lisaftoclax tablets either alone or combined with other medications (rituximab, acalabrutinib, ibrutinib, or zanubrutinib) for patients whose chronic lymphocytic leukaemia or small lymphocytic lymphoma has returned or not responded to previous treatments. The trial aims to find the best dose of lisaftoclax and evaluate its safety and effectiveness in treating these conditions.

Main inclusion criteria: Participants must be at least 18 years old, able to provide written consent, willing to follow study procedures, have confirmed CLL or SLL requiring treatment with at least one high-risk factor, an ECOG performance status of 0-2, platelet count above 30×109/l, normal blood clotting, adequate liver and kidney function, and use effective birth control if capable of having children.

Main exclusion criteria: Patients with other serious health conditions, pregnant or breastfeeding women, recent cancer in the past 2 years (except specific skin cancers), recent major surgery, active infections, known allergies to study medications, participation in another trial within 4 weeks, certain heart conditions, uncontrolled high blood pressure, recent drug or alcohol abuse, HIV, hepatitis B, hepatitis C, or any condition making participation unsafe cannot join.

Trial focus: The study evaluates lisaftoclax both as single treatment and in combinations with rituximab, acalabrutinib, ibrutinib, or zanubrutinib to determine the maximum tolerated dose and assess safety and effectiveness in treating relapsed or refractory CLL/SLL.

Investigational drugs: Lisaftoclax targets cancer cell survival proteins, rituximab helps the immune system attack cancer, acalabrutinib blocks cancer cell growth proteins, ibrutinib interferes with cancer cell growth and spread, and zanubrutinib targets specific proteins involved in cancer cell survival.

Study of Lisaftoclax and Acalabrutinib for Patients with Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This study compares lisaftoclax combined with acalabrutinib tablets against standard immunochemotherapy for patients newly diagnosed with chronic lymphocytic leukaemia or small lymphocytic lymphoma. Participants will be randomly assigned to receive either the new drug combination or traditional treatment, with the study monitoring progression-free survival and overall outcomes.

Main inclusion criteria: Participants must be at least 18 years old, able to provide written consent, willing to follow study procedures, have confirmed CLL or SLL requiring treatment with measurable disease and an ECOG performance status of 0-2. They need adequate blood counts (platelets >30×109/l), kidney function (creatinine clearance >30ml/min), liver function, and normal blood clotting. Women of childbearing age need negative pregnancy tests and must use effective birth control.

Main exclusion criteria: Patients who have not been newly diagnosed with CLL or SLL, those outside the specified age range, vulnerable populations not meeting other specific health criteria, or those unable to participate safely in the study cannot join.

Trial focus: The study compares progression-free survival between patients receiving lisaftoclax with acalabrutinib versus those receiving standard immunochemotherapy to determine which treatment approach is more effective for newly diagnosed CLL or SLL.

Investigational drugs: Lisaftoclax is being tested for its potential to treat CLL and SLL by targeting cancer cell survival proteins, whilst acalabrutinib blocks specific proteins involved in cancer cell growth, both being evaluated in combination against traditional immunochemotherapy approaches.

Summary

This overview covers 60 ongoing clinical trials for chronic lymphocytic leukaemia across multiple European countries. The trials test various treatment approaches including new BTK inhibitors (pirtobrutinib, nemtabrutinib, zanubrutinib, acalabrutinib), BCL-2 inhibitors (venetoclax, sonrotoclax, lisaftoclax), and combination therapies with monoclonal antibodies (obinutuzumab, rituximab). Several studies focus on specific patient populations including elderly or frail patients, those with high-risk genetic features, and patients whose disease has not responded to previous treatments.

Notable observations include significant concentration of trials testing combinations of targeted therapies rather than single agents, multiple studies evaluating treatment-free intervals or shortened treatment durations, and increased focus on measuring minimal residual disease to guide treatment decisions. Countries with the highest number of trial sites include Germany, Spain, France, Italy, and Poland, reflecting strong research infrastructure in these regions.

Ongoing Clinical Trials on Chronic lymphocytic leukaemia

  • A Study of Zanubrutinib for Patients with Anti-MAG Antibody Neuropathy Associated with Blood Disorders or Abnormal Protein in the Blood

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Venetoclax, Obinutuzumab, and Pirtobrutinib for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +8

  • Study of IDP-121 for Patients with Relapsed or Refractory Multiple Myeloma, B-cell Lymphoma, or Chronic Lymphocytic Leukemia

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Acalabrutinib for Adults with Chronic Lymphocytic Leukemia and Heart Issues

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Italy Poland Spain

  • Study of Ibrutinib for Treating Autoimmune Hemolytic Anemia in Patients with Chronic Lymphocytic Leukemia or Similar Conditions

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Zanubrutinib and Obinutuzumab for Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Venetoclax, Ibrutinib, and Rituximab for Patients with Untreated Chronic Lymphocytic Leukemia

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Ibrutinib and Obinutuzumab for Patients with Chronic Lymphocytic Leukemia Who Have Not Received Treatment Before

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Acalabrutinib, Obinutuzumab, and Venetoclax for Untreated High-Risk Chronic Lymphocytic Leukemia Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Portugal

  • Study on Ibrutinib and Venetoclax for Patients with Untreated Chronic Lymphocytic Leukemia

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Hungary Italy Poland Spain

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