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Ongoing Clinical Trials for Waldenström’s Macroglobulinemia

This article provides information about 8 ongoing clinical trials for Waldenström’s Macroglobulinemia, a rare type of blood cancer. Trials are taking place across multiple European countries and are testing various treatment combinations including targeted therapies, immunotherapies, and chemotherapy approaches. These studies include options for both newly diagnosed patients and those whose disease has returned or not responded to previous treatments.

Clinical trial locations

Evaluating Sonrotoclax Alone and Combined with Zanubrutinib for Patients with Previously Untreated or Relapsed/Refractory Waldenström Macroglobulinemia

This trial is evaluating two investigational drugs: sonrotoclax (a BCL2 inhibitor) and zanubrutinib (a Bruton tyrosine kinase inhibitor), used either alone or in combination. The study includes patients at different stages of the disease, from those who have never been treated to those whose disease has returned after previous therapies.

Inclusion criteria: Participants must be 18 years or older with a confirmed diagnosis. They must meet at least one criterion for needing treatment and have adequate organ function. The trial includes four cohorts: patients whose disease progressed after both BTK inhibitor and anti-CD20 antibody-based therapy, those who couldn’t tolerate BTK inhibitors, patients unsuitable for chemoimmunotherapy after BTK inhibitor failure, and newly diagnosed patients who haven’t received prior therapy.

Exclusion criteria: The study excludes patients who have never been treated or whose disease hasn’t been previously exposed to BTK inhibitors and anti-CD20 antibody therapy combined with chemotherapy or proteasome inhibitors.

Main focus: The trial aims to assess the effectiveness and safety of these treatments by tracking how well patients respond, monitoring side effects through regular laboratory tests and assessments, and evaluating quality of life using standardized questionnaires.

This study is taking place in France, Italy, Greece, and Spain.

Study on Venetoclax and Rituximab for Patients with Waldenström’s Macroglobulinemia

This trial compares the combination of venetoclax and rituximab against a different treatment regimen that includes dexamethasone, rituximab, and cyclophosphamide. Venetoclax is a BCL2 inhibitor that helps trigger cancer cell death, while rituximab is a monoclonal antibody targeting specific proteins on cancer cells.

Inclusion criteria: Patients must have a confirmed diagnosis, be 18 years or older, and have a life expectancy of more than 3 months. They must have adequate organ function, including baseline platelet counts of at least 50×10^9/L and neutrophil counts of at least 0.75×10^9/L. Women of childbearing potential must use effective birth control during the study and for 12 months after.

Exclusion criteria: Patients with other types of cancer, serious infections, or conditions that would make participation unsafe are excluded. Pregnant or breastfeeding women cannot participate.

Main focus: The study will measure the rate of complete or very good partial remission 12 months after starting treatment, along with other outcomes such as time to response, duration of response, and overall survival.

This study is taking place in Germany and Greece.

Long-Term Access to Ibrutinib for Patients with Lymphoma, Leukemia, and Other Conditions

This trial provides continued access to ibrutinib, a BTK inhibitor, for patients who have previously participated in ibrutinib clinical trials and continue to benefit from the treatment. The medication is used to treat various blood cancers, including Waldenström’s Macroglobulinemia.

Inclusion criteria: Patients must have participated in a previous ibrutinib trial and be benefiting from continued treatment as determined by their physician. Access to commercial ibrutinib must not be available in their region. Both men and women of childbearing potential must agree to use highly effective birth control during treatment and for 90 days after the last dose.

Exclusion criteria: Patients who have withdrawn consent from previous studies or who don’t meet eligibility criteria for long-term access are excluded.

Main focus: The study monitors long-term safety by tracking treatment-emergent serious adverse events and adverse events of special interest.

This study is taking place in Spain, Poland, Czechia, Italy, France, Sweden, and Hungary.

Long-Term Safety Study of Venetoclax for Patients with Chronic Lymphocytic Leukemia, Non-Hodgkin’s Lymphoma, Multiple Myeloma, or Acute Leukemia

This trial focuses on gathering long-term safety data for venetoclax, a BCL2 inhibitor, in patients who have previously participated in venetoclax studies. The medication works by blocking a protein that helps cancer cells survive.

Inclusion criteria: Patients must have completed a previous venetoclax study and their doctor must believe continuing treatment is beneficial. Those with multiple myeloma receiving venetoclax with a proteasome inhibitor must take preventive antibiotics during treatment and for at least 30 days after stopping.

Exclusion criteria: Patients with certain types of blood cancers listed in the exclusion criteria cannot participate in this specific extension study.

Main focus: The primary goal is to collect long-term safety data while patients continue treatment. Regular monitoring for adverse events and side effects is conducted throughout the study period, which continues until February 2026.

This study is taking place in Belgium, Denmark, Spain, France, Ireland, Greece, and Poland.

Study of CLR 131 for Patients with Relapsed or Refractory Waldenstrom Macroglobulinemia

This trial evaluates CLR 131, an experimental radiopharmaceutical that delivers a radioactive isotope directly to cancer cells. The treatment is given through intravenous infusion, along with oral potassium iodide as a supportive medication.

Inclusion criteria: Patients must have confirmed diagnosis, be 18 years or older, and have a life expectancy of at least 6 months. They must have received at least two prior lines of therapy and have an ECOG performance status between 0 and 2.

Exclusion criteria: Patients who haven’t received at least two previous treatments or who are not within the specified age range are excluded.

Main focus: The study evaluates overall response rate, duration of response, and treatment-free survival. Patients undergo regular assessments including vital signs, laboratory tests, and electrocardiograms to monitor response and safety.

This study is taking place in France, Spain, and Greece.

Study on Brexucabtagene Autoleucel for Adults with Relapsed/Refractory Waldenstrom Macroglobulinemia Using a Drug Combination

This trial tests brexucabtagene autoleucel, a CAR T-cell therapy that uses a patient’s own immune cells, modified in a laboratory to better fight cancer. The treatment is used in combination with other medications including ibrutinib, cyclophosphamide, and fludarabine.

Inclusion criteria: Patients must be 18 years or older with measurable disease (IgM protein more than twice the normal limit). They must have relapsed or refractory disease after at least two different treatments, including a BTK inhibitor. Adequate organ function and ECOG performance status of 0 or 1 are required.

Exclusion criteria: Patients who have had severe allergic reactions to similar treatments, are pregnant or breastfeeding, have active infections requiring treatment, serious heart conditions, or uncontrolled high blood pressure are excluded.

Main focus: The study involves leukapheresis to collect white blood cells, followed by lymphodepletion chemotherapy to prepare the body, then infusion of the modified cells. Patients are monitored closely for response and side effects through regular follow-up assessments.

This study is taking place in Netherlands, Austria, Germany, France, Spain, Italy, and Sweden.

Study on Carfilzomib and Ibrutinib for Patients with Waldenström’s Macroglobulinemia

This trial compares the combination of carfilzomib (a proteasome inhibitor) and ibrutinib (a BTK inhibitor) against ibrutinib alone. Carfilzomib is given intravenously, while ibrutinib is taken orally as a capsule.

Inclusion criteria: Patients must have confirmed diagnosis, be 18 years or older with a life expectancy of more than 3 months, and have a performance status of 2 or less. They must have adequate organ function and a left ventricular ejection fraction of 40% or more. The study includes both newly diagnosed patients and those with relapsed or refractory disease.

Exclusion criteria: Patients who have had previous treatment with carfilzomib or ibrutinib, have serious heart problems, uncontrolled high blood pressure, active infections, or are pregnant or breastfeeding are excluded.

Main focus: The study evaluates how long it takes for the disease to respond to treatment, how long the response lasts, and overall survival. Quality of life is also assessed during the treatment period.

This study is taking place in Austria, Germany, and Greece.

Study on the Effectiveness of Bortezomib, Rituximab, and Ibrutinib for Patients with Newly Diagnosed Waldenström’s Macroglobulinemia

This trial evaluates a combination of three medications: bortezomib (a proteasome inhibitor given by injection), rituximab (a monoclonal antibody given by infusion or injection), and ibrutinib (a BTK inhibitor taken as capsules). The study focuses specifically on patients who have not received any previous treatment.

Inclusion criteria: Patients must have confirmed diagnosis with at least one symptom requiring treatment, such as fever, night sweats, weight loss, fatigue, or organ involvement. They must be 18 years or older with a life expectancy of more than 3 months, have WHO/ECOG performance status of 0 to 2, and meet specific laboratory test criteria for blood counts and organ function.

Exclusion criteria: Patients who have already received treatment for the disease cannot participate. Those in vulnerable populations are also excluded.

Main focus: The study evaluates how effective the combination is in preventing disease progression over one year, tracking time to response, duration of response, and monitoring for side effects through regular check-ups and assessments.

This study is taking place in Germany and Greece.

Summary

The 8 ongoing clinical trials for Waldenström’s Macroglobulinemia represent a diverse range of treatment approaches across Europe. Greece appears in 6 trials, making it a significant hub for research in this condition, followed by France, Germany, and Spain. Several trials focus on BTK inhibitors like ibrutinib and zanubrutinib, often in combination with other agents. BCL2 inhibitors such as venetoclax and sonrotoclax are also prominently featured, reflecting their emerging importance in treatment strategies.

The trials include options for both newly diagnosed patients and those whose disease has returned or not responded to previous treatments. Newer approaches such as CAR T-cell therapy with brexucabtagene autoleucel and radiopharmaceutical treatment with CLR 131 represent innovative treatment strategies under investigation. Two trials specifically offer long-term access to medications for patients who have previously participated in clinical trials and continue to benefit from treatment.

Most studies require participants to be at least 18 years old with adequate organ function. The trials employ various outcome measures including response rates, duration of response, progression-free survival, and quality of life assessments. Patients interested in participating should discuss eligibility requirements and potential benefits and risks with their healthcare providers.

Ongoing Clinical Trials on Waldenstrom’s macroglobulinaemia

  • 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 and Rituximab for Patients with Waldenström’s Macroglobulinemia

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Greece

  • Evaluating Sonrotoclax Alone and Combined with Zanubrutinib for Patients with Previously Untreated or Relapsed/Refractory Waldenström Macroglobulinemia

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Greece Italy Spain

  • Long-Term Access to Ibrutinib for Patients with Lymphoma, Leukemia, and Other Conditions

    Not recruiting

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

  • Study on Brexucabtagene Autoleucel for Adults with Relapsed/Refractory Waldenstrom Macroglobulinemia Using a Drug Combination

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Italy The Netherlands Spain +1

  • Study on Carfilzomib and Ibrutinib for Patients with Waldenström’s Macroglobulinemia

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Greece

  • Study on the Effectiveness of Bortezomib, Rituximab, and Ibrutinib for Patients with Newly Diagnosed Waldenström’s Macroglobulinemia

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Greece

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