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
City of Hope Medical Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. Assess the feasibility of completing zanubrutinib lead-in and sonrotoclax ramp up in underrepresented minorities with relapsed/refractory (r/r) B cell non-Hodgkin lymphoma (B-NHL). II. Assess the feasibility of patient retention through 2 cycles of combination therapy at a steady dose in underrepresented minorities with r/r B-NHL. SECONDARY OBJECTIVES: I. Assess safety and tolerability. II. Estimate overall response rate (ORR). III. Estimate complete response (CR) rate. IV. Estimate time to response. V. Estimate progression free survival (PFS). VI. Estimate overall s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Age: ≥ 18 years on the day of signing the informed consent form * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Patients are of the following self-identified racial/ethnic groups: * Cohort 1: Patients in any of the following categories: * Black or African American * Hispanic or Latino * American Indian/Native Alaskan * Pacific Islander/Native Hawaiian * Any other patient that does…
Interventions
- ProcedureBiopsy
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo urine and blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
- ProcedureBone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- OtherQuestionnaire Administration
Location
- City of Hope Medical CenterDuarte, California