Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented 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 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.