Actively Recruiting
Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities
Led by City of Hope Medical Center · Updated on 2026-04-20
37
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating zanubrutinib combined with sonrotoclax to treat underrepresented ethnic and racial minorities who have relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). This phase I trial aims to assess the feasibility of treatment completion and patient retention among these groups, who often face additional challenges and lower participation in clinical trials. Zanubrutinib blocks a protein called BTK, and sonrotoclax blocks Bcl-2, both of which may help stop cancer cell growth and survival. Participants receive zanubrutinib orally once daily for the first two cycles, then start sonrotoclax orally once daily beginning with cycle three. Each treatment cycle lasts 28 days, and patients may continue for up to 28 cycles if the disease does not progress or toxicity is unacceptable. Throughout the study, patients undergo urine and blood sample collection, CT or MRI scans, possible biopsies at disease progression, and bone marrow aspirations and biopsies. During the trial, researchers monitor treatment feasibility, safety, and patient response, including overall and complete response rates, time to response, progression-free survival, and overall survival. They also explore factors related to healthcare disparities and assess quality of life and patient perceptions of clinical trial participation. After treatment ends, patients are followed up at 30 days and then every three months for up to three years.
CONDITIONS
Brief 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...
- Provided documented informed consent and assent when appropriate
- Age 18 years or older at the time of consent
- ECOG performance status of 2 or less
- Self-identified as Black or African American, Hispanic or Latino, American Indian/Native Alaskan, Pacific Islander/Native Hawaiian, or other underrepresented minorities, or as non-Hispanic White or Asian
- Confirmed diagnosis of relapsed or refractory subtypes of B-cell non-Hodgkin lymphoma, including diffuse large B cell lymphoma, follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma
- Measurable disease by CT or MRI or flow cytometry as appropriate
- Life expectancy of 6 months or more
- Adequate blood counts and organ function as specified
- Seronegative or controlled infection status for HIV, hepatitis B, and hepatitis C
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during study and 90 days after treatment
You will not qualify if you...
- Major surgery within 4 weeks before starting study drug
- Recent autologous stem cell transplant or CAR-T therapy within 30 days
- Active graft-versus-host disease or recent use of immunosuppressive drugs
- Prior therapy lasting 2 months or more with a Bcl-2 inhibitor or disease progression on such therapy
- Recent live vaccination within 35 days before study drug or during treatment
- Ongoing treatment with strong CYP3A inducers or warfarin derivatives
- Participation in another therapeutic clinical trial
- Recent biologic, chemotherapy, radiation, corticosteroid, or targeted small molecule therapy within specified timeframes
- Known central nervous system involvement or plasma cell neoplasm
- Uncontrolled or significant cardiovascular disease
- Prior malignancy within 3 years except certain treated cancers
- Severe bleeding disorders or recent stroke
- Severe pulmonary disease
- Inability to swallow capsules or significant gastrointestinal disorders
- Active infections requiring systemic therapy
- Medical conditions affecting safety or study interpretation
- Known active HIV or active hepatitis B or C infection not controlled
- Allergic reactions to study drug components
- Active autoimmune anemia or thrombocytopenia
- Pregnant or breastfeeding women
- Inability to comply with study procedures as assessed by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 cycles of 28 days each
Participants receive zanubrutinib orally once daily on days 1-28 of each cycle. Starting with cycle 3, participants also receive sonrotoclax orally once daily on days 1-28 of each cycle. Treatment cycles repeat every 28 days for up to 28 cycles unless there is disease progression or unacceptable toxicity. Participants undergo urine and blood sample collection, and CT or MRI scans throughout the study. Additional procedures such as biopsy at progression and bone marrow aspiration and biopsy may occur during treatment.
Visits every 28 days for treatment cycles; imaging and sample collection throughout
Duration - Up to 3 years
After completing study treatment, participants are followed up at 30 days and then every 3 months for up to 3 years to monitor safety and long-term outcomes.
1 visit at 30 days post-treatment and quarterly visits thereafter
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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