Trials / Recruiting

RecruitingNCT06859008

Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

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

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 37 (estimated)

Sponsor: City of Hope Medical Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed 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 survival (OS). EXPLORATORY OBJECTIVES: I. Assess demographics potentially related to health care disparities including the highest level of education within the home, primary language spoken by patient, distance from patient's home to treating institution, time from diagnosis of r/r B-NHL until seen at trial center and socioeconomic status by zip code of participant. II. Estimate minimum residual disease (MRD) rate for patients with chronic lymphocytic leukemia (CLL)/small cell leukemia (SLL) only. III. For the first 7 patients only: assess feasibility of using mobile phlebotomy for blood sample collection. IV. Evaluate the relationship between three-factor risk estimate scale (Tres) comorbidity score and survival outcomes. V. Assess patient-reported quality-of-life outcomes. VI. Assess patient-reported perceptions of clinical trial participation and barriers. OUTLINE: Patients receive zanubrutinib orally (PO) once daily (QD) on days 1-28 of each cycle. Starting with cycle 3, patients also receive sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 28 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection, and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. Additionally, patients may undergo biopsy at progression and bone marrow aspiration and biopsy throughout the study. After completion of study treatment, patients are followed up at 30 days then every 3 months for up to 3 years.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo urine and blood sample collection
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration and biopsy
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow aspiration and biopsy
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Sonrotoclax	Given PO
DRUG	Zanubrutinib	Given PO

Timeline

Start date: 2026-02-07
Primary completion: 2029-01-31
Completion: 2029-01-31
First posted: 2025-03-05
Last updated: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06859008. Inclusion in this directory is not an endorsement.