Chronic lymphocytic leukemia/Small lymphocytic lymphoma (CLL/SLL)
Conditions
Interventions
Experimental group:Sonrotoclax
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) based on the iwCLL criteria. 2. Patients who met the iwCLL criteria for treatment and had received at least 12 months of first-line BTK inhibitor monotherapy without evidence of disease progression. 3. Patients who failed to achieve undetectable minimal residual disease at a sensitivity of 10?4 (uMRD4) after BTK inhibitor monotherapy. 4.Patients with a clinical need for treatment discontinuation; 5. Patients with small lymphocytic lymphoma (SLL) must have had measurable disease on CT or MRI at the initiation of BTKi therapy, defined as >= 1 lymph node with a longest diameter >1.5 cm or >= 1 extranodal lesion with a longest diameter >1.0 cm, measurable in two perpendicular dimensions. 6. Participants must meet the following marrow function as defined below: a. Absolute neutrophil count (ANC) >= 0.75 × 10?/L without growth factor support or transfusion within the past 7 days. b. Platelet count >= 50 × 10?/L without growth factor support or transfusion within the past 7 days. c. Hemoglobin >= 75 g/L (transfusion permitted). 7. Adequate hepatic function, defined as AST and ALT = 60 mL/min (patients below this threshold may be eligible if deemed acceptable by the principal investigator). 9. Age >= 18 years. 10. ECOG performance status of 0, 1 or 2. 11. Expected survival > 6 months. 12. Provides written informed consent form and is willing and able to comply with all requirements of the study protocol. 13. Female patients of childbearing potential and male patients must be willing to use highly effective contraceptive methods during the study and for >= 90 days after the last dose of SZ. Male infertility is defined as azoospermia confirmed by semen analysis prior to study entry, which constitutes definitive evidence of male sterilization. In this study, men with known oligospermia or subfertility are not considered infertile. 14. Systemic corticosteroid therapy must be discontinued >= 5 days prior to enrollment, unless required for the management of comorbid conditions (e.g., autoimmune diseases).
Exclusion criteria
Exclusion criteria: 1. Any prior systemic therapy for CLL/SLL other than BTK inhibitor monotherapy,except those who received corticosteroid monotherapy for symptom control, who are eligible for enrollment; 2. Have a history of lymphocytic leukemia, a known history of Richter's transformation, or current suspicion of Richter's transformation; 3. Known central nervous system involvement by leukemia or lymphoma. 4. Poorly controlled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment; 5.Requires treatment with any moderate or strong CYP3A4 inhibitor within = 3 years prior to screening. b) Adequately treated non-melanoma skin cancer or malignant lentigo with no current evidence of disease. c) Adequately treated carcinoma in situ of the cervix with no current evidence of disease. d) Localized prostate cancer with a Gleason score <= 6. e) Other early-stage malignancies or carcinoma in situ that have been cured by surgery. 13. Inability to swallow tablets or the presence of significant gastrointestinal disorders that may affect drug absorption, such as malabsorption syndrome, history of gastric or small bowel resection, bariatric surgery, symptomatic inflammatory bowel disease, or partial/complete bowel obstruction. 14.Pregnant or breastfeeding women. 15.History of illicit drug or alcohol abuse within 12 months prior to screening, as determined by the investigator. 16.Receipt of live vaccines within 28 days prior to enrollment. 17.Consumption of grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit within 3 days prior to the first dose of study drug. 18.Any serious medical condition or clinically significant laboratory abnormality that may compromise patient safety or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| uMRD4 rate at the end of 12 cycles of combination therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of improved response;3-year progression-free survival 1 (3-year PFS);Complete response rate;Safety;Response improvement rate;Time to Next Treatment;Progression-free survival;Objective respond rate;Overall survival;Peripheral blood immune cell subsets, lymphocyte mitochondrial function, and cytokine secretion levels;Duration of response; | — |
Countries
China
Contacts
Public ContactDepei Wu
The First Affiliated Hospital of Soochow University
Outcome results
None listed