Actively Recruiting
Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Led by City of Hope Medical Center · Updated on 2026-04-20
37
Participants Needed
1
Research Sites
179 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.
CONDITIONS
Official Title
Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative provides documented informed consent
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Self-identifies as Black or African American, Hispanic or Latino, American Indian/Native Alaskan, Pacific Islander/Native Hawaiian, or other underrepresented racial/ethnic minority (Cohort 1) or as Non-Hispanic White or Non-Hispanic Asian (Cohort 2)
- Confirmed diagnosis of specific B-cell non-Hodgkin lymphoma subtypes including relapsed/refractory diffuse large B-cell lymphoma, follicular lymphoma (grade 1, 2, or 3a), marginal zone lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma
- Measurable disease by CT/MRI or flow cytometry as defined
- Life expectancy of at least 6 months
- Adequate blood counts and organ function as specified
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during the study and for 90 days after last dose
- Meets institutional and federal infectious disease testing requirements
You will not qualify if you...
- Major surgery within 4 weeks before first study drug dose
- Prior autologous stem cell transplant or CAR-T therapy within 30 days
- Active graft-versus-host disease or recent use of immunosuppressive drugs for GVHD
- Prior therapy exceeding 2 months with or progression on a Bcl2 inhibitor
- Recent live vaccination within 35 days before first dose or during study
- Ongoing treatment with strong CYP3A inducers or warfarin
- Participation in another therapeutic clinical trial
- Recent use of biologic, immunologic, chemotherapy, radiation, corticosteroids, BTK inhibitors, or targeted therapies within specified time frames
- Known central nervous system lymphoma/leukemia involvement
- Known plasma cell neoplasm, prolymphocytic leukemia, or suspected Richter's syndrome
- Significant cardiovascular disease including recent myocardial infarction, unstable angina, severe arrhythmias, or heart block without pacemaker
- Prior malignancy within 3 years except specified exceptions
- History of severe bleeding disorders or recent stroke/hemorrhage
- Severe pulmonary disease
- Unable to swallow capsules or significant gastrointestinal disorders
- Active infections requiring systemic therapy
- Underlying medical conditions posing risk or complicating assessment
- Active HIV infection or active hepatitis B or C infection as specified
- History of allergic reactions to similar study agents
- Active autoimmune anemia or thrombocytopenia
- Pregnant or breastfeeding females
- Inability to comply with study procedures as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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