Study on the Effectiveness and Safety of Sonrotoclax for Treating Waldenström's Macroglobulinemia
Sponsor: BeiGene
ClinicalTrials ID:NCT05952037
This clinical trial is testing a new drug, sonrotoclax, to see if it can help treat Waldenström's Macroglobulinemia, a type of blood cancer. The study will look at how well the drug works on its own in patients whose cancer has returned or not responded to other treatments, and in combination with another drug, zanubrutinib, in patients who have not yet been treated.
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Program Overview
The purpose of this study is to find out if the drug sonrotoclax can improve outcomes for people with Waldenström's Macroglobulinemia (WM), a type of blood cancer. The study will test sonrotoclax alone in patients whose cancer has come back or not responded to other treatments, and in combination with zanubrutinib in patients who have not yet received treatment. Researchers want to see how many patients show improvement or have no signs of cancer after treatment, and what side effects they might experience. Sonrotoclax works by blocking a protein called BCL2, which is involved in cell death and is often found at abnormal levels in cancer cells. The study will include about 105 participants worldwide, and they will take sonrotoclax as a tablet. The study will last about 5 years, and treatment will continue until the cancer worsens, side effects become too severe, or participants choose to stop.
Description
This study is testing a new treatment called sonrotoclax for people with Waldenström's Macroglobulinemia (WM), a type of blood cancer. The study will see if sonrotoclax can help patients whose cancer has returned or not responded to other treatments, and if it can be effective when combined with another drug, zanubrutinib, in patients who have not yet been treated. The main goals are to see how many patients show improvement or have no signs of cancer after treatment, and to identify any side effects. Sonrotoclax works by blocking a protein called BCL2, which is involved in cell death and is often found at abnormal levels in cancer cells. The study will include about 105 participants worldwide, and they will take sonrotoclax as a tablet. The study will last about 5 years, and treatment will continue until the cancer worsens, side effects become too severe, or participants choose to stop.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of Waldenström's Macroglobulinemia (WM).
- Must meet at least one treatment criterion according to international guidelines for WM.
- For certain groups, the cancer must have returned or not responded to the most recent treatment, unless the patient could not tolerate the treatment. Refractory disease means the cancer did not improve or got worse during or shortly after treatment. Relapsed disease means the cancer improved with treatment but then got worse again after some time.
- For another group, patients must not have received any prior treatment for WM.
- Must have adequate organ function.
Exclusion Criteria
- Cancer has spread to the central nervous system (brain or spinal cord).
- Cancer has changed into a more aggressive type, like diffuse large B-cell lymphoma.
- History of other cancers within the last 2 years.
- Uncontrolled active infection or recent infection that required strong antibiotics within 14 days before starting the study drug.
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