Clinical Trial TitleStudy of acalabrutinib alone or in combination with rituximab in indolent B-cell non-Hodgkin lymphoma.
Clinical Trial Protocol Description:
Both follicular lymphoma and marginal zone lymphoma (MZL) are classified as indolent B-cell non-Hodgkin lymphoma (NHL), which is generally a slow-growing and incurable disease.
The purpose of this study is to find out if acalabrutinib given either twice daily by mouth or acalabrutinib given twice daily by mouth along with Rituxan® (rituximab, given as an IV infusion) will slow or stop your marginal zone cancer from getting worse. Acalabrutinib is a type of drug that blocks proteins inside cells that help cells live and grow. The specific protein blocked by acalabrutinib is believed to help blood cancer cells live and grow. It is possible that acalabrutinib may kill the cancer cells or stop them from growing.
Participants in this study will be assigned to one of the two cohorts. The first 20 patients enrolled in the study will be assigned to group 1. The last 20 patients will be assigned to group 2. Group 1 patients will receive 100 milligrams capsules of acalabrutinib twice a day. Group 2 patients will receive 100 milligrams capsules of acalabrutinib twice a day and then receive rituximab in the clinic as an IV infusion during cycle 1, days 1, 8, 15 and 22; and day 1 of cycles 2 through 6.
A patient’s participation will last approximately 14 months, and will include coming to the study center approximately 18 times as long as they and the study doctor feel that they are tolerating the study treatment and their disease is not getting worse.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have confirmed marginal zone lymphoma.
- Have previously received 1 or more treatments for your cancer.
- Are able to take oral medications.
You will be excluded from the study if any of the following criteria apply to you:
- Have had a previous cancer (other than indolent B-cell NHL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which you have been disease free for 2 years or more.
- Have known evidence of your cancer transforming to another aggressive lymphoma.
- Have a life-threatening illness, medical condition, or organ system dysfunction or significant cardiovascular disease.
- Have received any immunotherapy within 4 weeks of your first dose of study drug.
- Have had prior exposure to a BCR inhibitor (BTK, PI3K, or SYK inhibitors) or BCL-2 inhibitor.
This is a partial list of inclusion and exclusion criteria.