Zanubrutinib and Sonrotoclax for the Treatment of Relapsed Chronic Lymphocytic Leukemia /Small Lymphocytic Leukemia, ZeuS-2 Trial

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07812246
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Lymph Node Biopsy — PROCEDURE
    Undergo lymph node biopsy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Sonrotoclax — DRUG
    Given PO
  • Zanubrutinib — DRUG
    Given PO

Study Details

This phase II trial tests how well giving zanubrutinib and sonrotoclax works for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) that has come back after a period of improvement (relapsed). Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) and BCL-XL inhibitors. It may stop the growth of tumor cells and may kill them by blocking Bcl-2 and Bcl-XL, proteins needed for cell survival. Giving zanubrutinib and sonrotoclax may work well for the treatment of relapsed CLL/SLL.

Key Dates

First listed
Sep 10, 2026
Start date
Aug 4, 2027
Status verified
Sep 2026
Primary completion
Aug 13, 2028
Completion
Aug 13, 2028

Study Design

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

Arms

  • Experimental: Treatment (zanubrutinib and sonrotoclax)
    CYCLE 1-4: Patients receive zanubrutinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. CYCLE 5+: Patients receive zanubrutinib PO QD and sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration, CT scan/MRI and blood sample collection throughout the study. Patients may undergo lymph node biopsy during screening and optionally at time of progression.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Tanya Siddiqi
[email protected]
626-803-3458
Tanya Siddiqi (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Tanya Siddiqi
[email protected]
626-803-3458
Tanya Siddiqi (PRINCIPAL_INVESTIGATOR)
City of Hope Atlanta Cancer CenterNewnanGeorgia30265
Sabarish R. Ayyappan
[email protected]
770-400-6568
Sabarish R. Ayyappan (PRINCIPAL_INVESTIGATOR)

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