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

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.

Conditions

• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3a Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Nodal Marginal Zone Lymphoma
• Recurrent Splenic Marginal Zone Lymphoma
• Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Refractory Grade 1 Follicular Lymphoma
• Refractory Grade 2 Follicular Lymphoma
• Refractory Grade 3a Follicular Lymphoma
• Refractory Mantle Cell Lymphoma
• Refractory Nodal Marginal Zone Lymphoma
• Refractory Splenic Marginal Zone Lymphoma

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Geoffrey Shouse · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-25

Primary Completion

2029-01-31

Completion

2029-01-31

FDA Drug

Yes

Countries

• United States

Study Locations