OncoMatch/Clinical Trials/NCT07671378
A Study of MRD-Guided Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk CLL/SLL Patients
Is NCT07671378 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Zanubrutinib and sonrotoclax for cll (chronic lymphocytic leukemia).
Treatment: Zanubrutinib and sonrotoclax — This study is a prospective, multicenter, open-label, single-arm phase II clinical trial evaluating the efficacy and safety of an MRD-guided, time-limited therapy with zanubrutinib combined with sonrotoclax in previously untreated high-risk CLL/SLL patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: TP53 mutation
del(17p)/TP53 mutation
Required: IGHV unmutated
unmutated IGHV
Required: CLL-IPI high-risk or very high-risk
CLL-IPI high-risk/very high-risk
Required: DEL(11Q) deletion
del(11q)
Required: DEL(17P) deletion
del(17p)/TP53 mutation
Required: COMPLEX KARYOTYPE complex karyotype
complex karyotype
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: chemotherapy for CLL/SLL
Any prior treatment for CLL or SLL (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and/or monoclonal antibody therapy)
Cannot have received: targeted therapy for CLL/SLL
Any prior treatment for CLL or SLL (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and/or monoclonal antibody therapy)
Cannot have received: immunomodulatory therapy for CLL/SLL
Any prior treatment for CLL or SLL (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and/or monoclonal antibody therapy)
Cannot have received: radiotherapy for CLL/SLL
Any prior treatment for CLL or SLL (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and/or monoclonal antibody therapy)
Cannot have received: monoclonal antibody therapy for CLL/SLL
Any prior treatment for CLL or SLL (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and/or monoclonal antibody therapy)
Lab requirements
Blood counts
ANC > 0.75 × 10⁹/L, platelet count > 30 × 10⁹/L, hemoglobin > 80 g/L, without transfusion or hematopoietic growth factor support for at least 7 days prior to enrollment (at least 14 days for pegylated G-CSF such as pegfilgrastim)
Kidney function
Creatinine clearance (CrCl) ≥ 60 mL/min (estimated by Cockcroft-Gault formula)
Liver function
AST or ALT ≤ 3.0 × ULN; total bilirubin ≤ 1.5 × ULN (unless due to Gilbert's syndrome or other non-hepatic causes)
Adequate major organ function meeting the following criteria: Hematologic function: without transfusion or hematopoietic growth factor support for at least 7 days prior to enrollment (at least 14 days for pegylated G-CSF such as pegfilgrastim), and meeting the following criteria: absolute neutrophil count (ANC) > 0.75 × 10⁹/L, platelet count (PLT) > 30 × 10⁹/L, hemoglobin (Hb) > 80 g/L. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN). Creatinine clearance (CrCl) ≥ 60 mL/min (estimated by Cockcroft-Gault formula). Total bilirubin (TBIL) ≤ 1.5 × ULN (unless due to Gilbert's syndrome or other non-hepatic causes).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07671378 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Does this trial require IGHV?
Yes, IGHV unmutated is a required biomarker for enrollment.
Does this trial require CLL-IPI?
Yes, CLL-IPI high-risk or very high-risk is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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