Ongoing Clinical Trials for Relapsed Waldenström’s Macroglobulinaemia

Currently, there is 1 ongoing clinical trial for patients with Waldenström’s macroglobulinaemia that has returned after previous treatment. This trial is testing a new combination of medications in multiple European countries, offering hope for patients whose disease has not responded to earlier therapies or has come back after initial treatment.

Clinical trial locations

• Germany
  • Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
• Italy
  • Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
• Poland
  • Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies

Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies

This trial is being conducted in Poland, Germany, and Italy and is studying new treatment combinations for patients whose B-cell cancer, including Waldenström’s macroglobulinaemia, has returned or not responded to previous treatments.

Who can participate:

• Adults aged 18 years or older
• Patients with confirmed diagnosis of B-cell cancer that has relapsed (come back) or is refractory (did not respond to treatment)
• Those with good physical function and able to perform daily activities with minimal limitations
• Patients with adequate organ function, including kidney function with specific requirements depending on the treatment group
• For certain treatment groups, patients who are either new to BTK inhibitor treatment or have stopped previous BTK inhibitor therapy for reasons other than disease progression
• Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting treatment
• Men who are not sterile must use effective birth control during the study

Who cannot participate:

• Patients under 18 years of age
• Those with active cancer involvement in the central nervous system (brain and spinal cord)
• Patients who have received similar experimental therapy previously or participated in another clinical trial within 30 days
• Those with active, uncontrolled infections
• Patients with significant heart problems, including heart failure or unstable heart rhythm
• Those with severe kidney or liver problems
• Pregnant or breastfeeding women
• Patients with other cancers within the past 3 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
• Those with known HIV infection or active hepatitis B or C
• Patients who have had major surgery within 4 weeks before starting the study
• Those with uncontrolled high blood pressure or other serious medical conditions that could make participation unsafe

What the trial focuses on:

The study aims to find safe and effective treatment combinations for patients whose cancer has returned or did not respond to earlier treatments. It is conducted in two parts: the first part will determine the right dose of the drug combinations, while the second part will study how well these doses work and what side effects they may cause.

During the trial, doctors will closely monitor patients’ health, check how well the treatment is working, and track any side effects. They will measure how many patients respond to treatment and how long the response lasts. For some patients, doctors will also measure the amount of cancer cells remaining in the blood or bone marrow after treatment.

Investigational drugs being tested:

The main medication in this trial is BGB-16673, an experimental drug known as a BTK-degrader. This medication works by breaking down a specific protein called BTK that is important in B-cell cancers. BGB-16673 is given as tablets taken by mouth.

Depending on which treatment group patients are assigned to, they may also receive other medications including:

• Zanubrutinib – taken as oral capsules
• Sonrotoclax – part of the combination therapy
• Mosunetuzumab – given as an injection under the skin
• Obinutuzumab (Gazyvaro) – given through intravenous infusion (directly into a vein)
• Glofitamab (Columvi) – given through intravenous infusion

The medications are administered in different ways to work together in targeting the cancer from multiple angles. After completing treatment, patients will need to continue using birth control methods for a specified period that varies depending on which medications they received, ranging from 30 days to 18 months after the last dose.

Summary

Currently, there is one clinical trial available for patients with relapsed Waldenström’s macroglobulinaemia, being conducted across three European countries: Poland, Germany, and Italy. This trial represents an important research effort testing a novel approach to treating B-cell cancers that have returned or not responded to previous treatments.

The study focuses on BGB-16673, a new type of medication called a BTK-degrader, which works differently from traditional BTK inhibitors by actually breaking down the BTK protein rather than just blocking it. This innovative approach is being tested in combination with several other medications to potentially improve outcomes for patients.

The trial is designed in two stages: first establishing safe dosing levels, then evaluating effectiveness and monitoring side effects. This careful approach ensures patient safety while gathering important information about how well these new treatment combinations work. Patients interested in participating should discuss their eligibility with their healthcare provider, keeping in mind the specific health requirements and the need for adequate organ function.