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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06859008
Phase
PHASE1
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 25, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (zanubrutinib, sonrotoclax)
    Patients receive zanubrutinib PO 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 CT or MRI throughout the study. Additionally, patients may undergo biopsy at progression and bone marrow aspiration and biopsy throughout the study.

Primary Outcome Measure

Feasibility of completing zanubrutinib lead-in (cycle 1 and cycle 2) and sonrotoclax ramp up (cycle 3) [ Time Frame: From start of cycle 1 through end of cycle 3 (cycle length = 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Geoffrey Shouse
[email protected]
626-239-5289
Geoffrey Shouse (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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