What is the purpose of the CLOVER-WaM study?
The CLOVER-WaM study is researching a possible new therapy for people with Waldenstrom Macroglobulinemia (WM). Because approved therapies for WM offer only a small chance of remission, this study is researching another way to manage this disease.
Who can join the CLOVER-WaM study?
To qualify for this study, you must meet the following requirements:
- Be 18 years of age or older
- Have confirmed diagnosis of WM
- Have received previous care for your WM
- Have never had total body or hemi-body irradiation
Note: other criteria apply.
What will happen during the study?
If you qualify and decide to join the CLOVER-WaM study, your participation will last about 3.5 years. During this time, you will go through 3 study periods:
- Screening (up to 28 days) – Receive study tests to confirm you qualify for the study. These tests include blood tests, imaging tests, and a bone marrow biopsy, if you have not had one done in the past 6 months.
- Study therapy (up to 6 months) – Visit the study clinic to receive your infusions of the study therapy, CLR 131, twice per cycle, for a total of 4 times. The study team will perform tests and assessments to check your health throughout both cycles and for about 57 days post the last dose. Your health will be monitored throughout both cycles and actively for the first year from initial dosing.
- Follow-up (2 years) – Complete study clinic visits twice during the first year after the last cycle of the study therapy, then once a year for 2 more years. This will give the study team more information about your health and how the study therapy works.
Travel support may be provided as allowed by local regulations and study centers.
Note: The study therapy, CLR 131, is an investigational study therapy. An investigational study therapy is one that has not been approved by the US Food and Drug Administration (FDA) or any other regulatory agency.