Study Comparing Zanubrutinib with Bendamustine and Rituximab for Untreated CLL or SLL
Sponsor: BeiGene
ClinicalTrials ID:NCT03336333
This clinical trial is comparing the effectiveness of the drug zanubrutinib against a combination of bendamustine and rituximab in patients who have not yet received treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to see how well the drug zanubrutinib works compared to the combination of bendamustine and rituximab in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not been treated before. The main focus is on how long patients live without the disease getting worse, as reviewed by an independent team.
Description
This is a large, international study where participants are randomly assigned to receive either zanubrutinib or a combination of bendamustine and rituximab. The study includes people with CLL or SLL who have not been treated before, and it looks at different groups based on specific genetic factors. In one group, participants will receive zanubrutinib alone, while another group will receive zanubrutinib along with another drug called venetoclax. The study will consider factors like age, disease stage, and genetic markers when assigning treatments.
Eligibility Criteria
Inclusion Criteria
- Not suitable for a specific type of chemotherapy called FCR.
- Diagnosed with CD20-positive CLL or SLL and need treatment.
- Have measurable disease that can be seen on scans.
- In good general health, with a performance status score of 0, 1, or 2.
- Expected to live at least 6 more months.
- Have good bone marrow, kidney, and liver function.
Exclusion Criteria
- Have had previous treatment for CLL/SLL.
- Need ongoing steroid treatment.
- Have a specific type of leukemia or a history of a condition called Richter's transformation.
- Have serious heart disease.
- Have had another cancer in the past 3 years, except for certain skin, bladder, cervical, or prostate cancers.
- Have a history of severe bleeding disorders.
- Have had a stroke or brain bleed in the past 6 months.
- Have severe lung disease.
- Cannot swallow capsules or have digestive issues.
- Have an active infection needing treatment.
- Have leukemia or lymphoma affecting the brain or spinal cord.
- Have a medical condition that makes the study drug unsafe or affects the study results.
- Have HIV or active hepatitis B or C.
- Have had major surgery in the past 4 weeks.
- Are pregnant or breastfeeding.
- Have had a live vaccine in the past 35 days.
- Have ongoing alcohol or drug addiction.
- Are allergic to any of the study drugs.
- Need treatment with certain other medications.
- Are in another clinical study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Augusta University | 30912 | Augusta | Georgia |
| Northwestern University | 60611 | Chicago | Illinois |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Research Medical Center | 64132 | Kansas City | Missouri |
| Washington University | 63110 | St Louis | Missouri |
| Comprehensive Cancer Centers of Nevada | 89169 | Las Vegas | Nevada |
| Summit Medical Group | 07932 | Florham Park | New Jersey |
| Icahn School of Medicine At Mount Sinai | 10029 | New York | New York |
| Columbia University Medical Center | 10032 | New York | New York |
| University of Rochester | 14642 | Rochester | New York |
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