Indolent Lymphoma
Conditions
Interventions
A group:Liso-cel monotherapy, used for patients with indolent lymphoma (CLL/WM/MZL) who have not received prior treatment and have severe underlying diseases that prevent the initiation of BTK inhibit
B group:Lisarotoclax monotherapy, used for patients with indolent lymphoma (CLL/WM/WZL) who are intolerant to BTK inhibitor therapy
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years at the time of signing the informed consent form (ICF). 2. Histologically confirmed diagnosis of an indolent lymphoma (CLL/WM/MZL), meeting one of the following conditions: Cohort A: Previously untreated and ineligible for Bruton's Tyrosine Kinase inhibitor (BTKi) therapy due to severe comorbidities (e.g., uncontrolled hypertension, cardiac disease, or active infection, etc.). Cohort B: Received only one prior line of BTKi as first-line treatment, did not achieve a partial response (PR), and discontinued BTKi due to intolerable treatment-related adverse events (e.g., atrial fibrillation, hemorrhage, infection, rash, etc.). 3. Sufficient bone marrow function, defined as follows: (1) Hemoglobin (HB) >= 70 g/L (without transfusion support within 7 days prior to first administration of the investigational drug); (2) Absolute neutrophil count (ANC) >= 0.5 × 10^9/L (without reliance on growth factor support within 7 days prior to first administration of the investigational drug); (3) Platelet count >= 50 × 10^9/L (without transfusion support within 7 days prior to first administration of the investigational drug. If the patient has bone marrow infiltration, a platelet count >= 30 × 10^9/L is acceptable, in which case the investigator should provide adequate supportive treatment); 4. Sufficient liver and kidney function, defined as follows: (1) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 40 ml/min (estimated by the Cockcroft-Gault formula); (3) Total bilirubin = lower limit of normal (50%); 6. Eastern Cooperative Oncology Group (ECOG) performance status = 3 months; 8. Men, women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant), and their partners must agree to use highly effective contraception methods (e.g., condoms, implants/injections/oral contraceptives, intrauterine devices [IUD], abstinence, or a sterilized partner) during the treatment period and for 90 days after the last dose of the study drug. Postmenopausal women (at least 12 months of spontaneous amenorrhea) or surgically sterile women are not considered WOCBP. 9. No other active malignant disease within the past 3 years, except for currently treated basal cell.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received treatment with B-cell lymphoma 2 (BCL-2) inhibitors; 2. Patients with active infections (including active hepatitis B or C virus infection, HIV positive) or any other severe (unrecovered) diseases. Note: (1) Patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), if HBV DNA is below the detectable limit and are willing to undergo monthly HBV reactivation monitoring, can be enrolled. (2) Patients who are positive for hepatitis C virus (HCV) antibody, if HCV RNA is below the detectable limit, can be enrolled. 3. Patients with other malignancies that may affect the study drug use or interfere with efficacy assessment, or with severe coagulation disorders and severe impairment of heart, brain, lung, liver, kidney, or other organ functions. 4. Patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 12 months prior to the first administration of the study drug. 5. Patients who received live vaccines within 28 days prior to the first administration of the study drug. 6. Patients of reproductive potential who are unwilling to use highly effective contraception; women who are pregnant or breastfeeding. 7. Patients unable to swallow tablets or with malabsorption syndrome, diseases severely affecting gastrointestinal function, or gastric/small intestine resection, symptomatic inflammatory bowel disease or ulcerative colitis, or incomplete/complete intestinal obstruction. 8. Patients with known allergy to any components, excipients, or analogs of the study drug. 9. Patients requiring treatment with strong cytochrome P450 (CYP)3A inhibitors/inducers. 10. Patients with any life-threatening diseases, medical conditions, or organ dysfunctions that the investigator believes may affect patient safety or pose study risks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;Time to response;Minimal Residual Disease;Overall response rate;Complete response rate; | — |
Countries
China
Contacts
Public ContactKeshu Zhou
Henan Cancer Hospital
Outcome results
None listed