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.
Documented informed consent of the participant and/or legally authorized representative.
Assent, when appropriate, will be obtained per institutional guidelines
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Chronic use of corticosteroids in excess of 20 mg/day prednisone
Major surgery (under general anesthesia) ≤4 weeks of the first dose of study drug
Prior chemotherapy
Refractory to prior BTK or BCL2 inhibitor (defined as relapsed within/< 6 months after completion of initial fixed duration regimen)
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow aspiration
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow biopsy
Computed Tomography
Procedure/SurgeryUndergo CT scan
Lymph Node Biopsy
Procedure/SurgeryUndergo lymph node biopsy
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Sonrotoclax
DrugGiven PO
Zanubrutinib
DrugGiven PO
Overall response rate
Overall response defined as achieving best response of complete response (CR) or partial response (PR) after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. Overall response rate will be calculated as the proportion of response-evaluable participants achieving an overall response. Will be estimated as a binary proportion; the 95% Clopper-Pearson confidence interval will be calculated when needed.
Complete response rate
Complete response defined as achieving best response of CR after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. Complete response rate will be calculated as the proportion of response-evaluable participants achieving CR. Will be estimated as a binary proportion; the 95% Clopper-Pearson confidence interval will be calculated when needed.
Minimal residual disease (MRD) negativity
MRD negativity is defined as less than 10\^-4. MRD will be assessed in the blood by flow cytometry.
Progression free survival
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
Duration of response
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
