[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mzl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mzl":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,71,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100612860","phase-1-multicenter-single-arm-exploratory-phase-i-clinical-study-assessment-of-safety-and-efficacy-of-fully-human-baff-r-chimeric-antigen-receptor-t-cell-injection-in-relapsedrefractory-baff-r-positive-b-cell-lymphoma-100612860",false,"NCT07259070","Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Multicenter, Single-Arm Exploratory Phase I Clinical Study on the Safety and Efficacy of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Participants With Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Inclusion Criteria:\n\n1.Relapsed and refractory (R\u002FR) BAFF-R-positive B-cell lymphoma:The diagnosis of B-cell lymphoma must be confirmed in accordance with the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (Version 1.2020) (NCCN: National Comprehensive Cancer Network).The expression of BAFF-R on tumor cells must be detected by flow cytometry (for patients where current clinical sampling is not feasible, test results obtained within 90 days prior to signing the informed consent form are acceptable). Investigators will determine whether to accept test results from external hospitals and whether the patient is eligible for enrollment.In accordance with the 2014 Lugano Classification, B-cell lymphoma patients must have at least one measurable lesion with a longest diameter ≥ 1.5 cm, or bone marrow involvement confirmed by bone marrow flow cytometry.Patients who have received CD19-targeted therapy are also eligible for enrollment, including those who have undergone:\n\n1. :Relapsed and refractory (R\u002FR) mantle cell lymphoma (MCL):Histologically confirmed MCL;Relapsed or refractory after at least 2 lines of prior treatment (including anti-CD20 monoclonal antibody and Bruton's tyrosine kinase inhibitor \\[BTKi\\]).\n2. :Relapsed and refractory (R\u002FR) chronic lymphocytic leukemia (CLL):Histologically confirmed CLL;Patients who have received at least immunochemotherapy and are refractory to both BTK inhibitors and B-cell lymphoma 2 (BCL2) inhibitors.\n3. :Relapsed and refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL):Histologically confirmed DLBCL;Patients who have received anthracycline-based therapy and anti-CD20 monoclonal antibody therapy, and have undergone at least 2 lines of treatment in total; or patients who failed to achieve remission, progressed, or relapsed within 12 months after initial standard treatment.\n4. :Relapsed and refractory (R\u002FR) follicular lymphoma (FL):Histologically confirmed FL (Grade 1-3a);Patients who have received anti-CD20 monoclonal antibody-containing therapy and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n5. :Relapsed and refractory (R\u002FR) marginal zone lymphoma (MZL):Histologically confirmed MZL;Patients who have received anti-CD20 monoclonal antibody-containing therapy, have undergone at least 2 lines of treatment in total and relapsed thereafter; or patients who relapsed within 24 months after initial treatment.\n6. :Relapsed and refractory (R\u002FR) Waldenström macroglobulinemia (WM):Histologically confirmed WM;Patients who have received anti-CD20 monoclonal antibody-containing therapy and BTK inhibitor-containing therapy (among other medications), and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n\n2.Aged ≥ 18 years and ≤ 75 years, with no restriction on gender. 3.Expected survival time ≥ 12 weeks. 4.Serum total bilirubin ≤ 37.2 μmol\u002FL (for patients with Gilbert syndrome: serum total bilirubin ≤ 3.0 × upper limit of normal \\[ULN\\], direct bilirubin ≤ 1.5 × ULN); estimated glomerular filtration rate \\[eGFR\\] (calculated by CKD-EPI formula) ≥ 30 ml\u002Fmin\u002F1.73m²; alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] \\\u003C 2.5 × upper limit of normal \\[ULN\\].\n\n5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6.Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography; oxygen saturation \\> 91%.\n\n7.The participant and their spouse\u002Fpartner must agree to use effective barrier or pharmaceutical contraceptive methods from the time the participant signs the informed consent form until one year after CAR-T cell infusion. For female participants of childbearing potential, serum or urine pregnancy test results must be negative during the screening period.\n\n8.Voluntarily participate in this trial and sign the Informed Consent Form (ICF).\n\n1. ： The patient has a full understanding of this study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).\n2. ：Aged ≥ 18 years and ≤ 75 years, with no restriction on gender.\n\nExclusion Criteria:\n\n1. Patients with a history of allergy to any component of the cellular product.\n2. Patients with acute graft-versus-host disease (aGVHD) graded as Grade II-IV according to the Glucksberg criteria, or with severity graded as Grade B-D according to the IBMTR index; patients with acute or chronic graft-versus-host disease (cGVHD) requiring systemic treatment within 4 weeks prior to enrollment.\n3. Participants who have received a live vaccine injection within 4 weeks prior to enrollment.\n4. Patients with central nervous system (CNS) diseases unrelated to lymphoma central nervous system involvement (e.g., cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, psychiatric disorders, etc.). Lymphoma central nervous system involvement or gastrointestinal tract involvement is not an exclusion criterion, but eligibility for enrollment shall be determined by the investigator.\n5. Patients with severe active infections (except uncomplicated urinary tract infections and bacterial pharyngitis), or those currently receiving intravenous antibiotic therapy. However, prophylactic use of antibiotics, antiviral drugs, and antifungal drugs is permitted.\n6. Patients who are positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B virus (HBV) DNA in peripheral blood.\n7. Patients who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood.\n8. Patients with other acquired or congenital immunodeficiency diseases, including but not limited to those positive for human immunodeficiency virus (HIV) antibody; patients with cytomegalovirus (CMV) DNA test value \\> 400 copies\u002FmL; patients with positive syphilis test results.\n9. Patients with heart failure classified as Grade III or IV according to the New York Heart Association (NYHA) Functional Classification (see Appendix II).\n10. Patients with a history of other primary malignancies, except for the following cases:Non-melanoma skin cancer (e.g., basal cell carcinoma of the skin) cured by resection;In situ carcinoma cured (e.g., cervical cancer, bladder cancer, breast cancer, etc.);Other primary malignancies with no recurrence detected for more than 5 years after treatment.\n11. Patients with a history of solid organ transplantation.\n12. Patients with a history of autoimmune diseases (predominantly characterized by abnormal cellular immunity), as well as patients with immunodeficiency or those requiring immunosuppressive therapy.\n13. Patients who received investigational drugs from other interventional clinical trials within 3 months prior to signing the Informed Consent Form (ICF).\n14. Pregnant women or women who are breastfeeding.\n15. Patients with psychiatric disorders, consciousness disturbances, or central nervous system (CNS) diseases.\n16. Patients whose toxic effects from prior treatment have not resolved to baseline or ≤ Grade 2 (per NCI-CTCAE Version 5.0, alopecia excluded).\n17. Medication use:Corticosteroids: Use of therapeutic-dose corticosteroids within 72 hours prior to CAR-T cell infusion; however, physiological-dose corticosteroid replacement is permitted (hydrocortisone \\\u003C 12 mg\u002Fm²\u002Fday or its equivalent dose)；Systemic antineoplastic therapy: Failure to discontinue systemic antineoplastic therapy for at least 2 weeks or 5 drug half-lives prior to T cell apheresis (except for BTK inhibitors in patients with CLL); the interval between T cell apheresis and the use of immune checkpoint inhibitors is less than 3 drug half-lives.\n18. Patients with active pulmonary infections.\n19. Patients with contraindications to peripheral blood apheresis.\n20. Patients deemed unsuitable for participation in this trial by the investigator after careful consideration for other reasons.","ALL","18 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD).\n\nThe secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma.\n\nThe study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.",[28,29,30,31,32,33],"DLBCL","CLL","FL","MCL","WM","MZL","RECRUITING","2026-05-10",{"date":37,"type":38},"2026-05-13","ACTUAL",{"date":40,"type":38},"2025-11-29",{"date":42,"type":21},"2029-11-28",{"name":44,"class":45},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100630802","cd20-monoclonal-antibody-based-first-line-therapy-in-treatment-naive-marginal-zone-b-cell-lymphoma-100630802","NCT07492407","CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma","Risk-Stratified Real-World Multicenter Study of the Efficacy and Safety of CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed marginal zone B-cell lymphoma (MZL) in accordance with the 2016 WHO classification;\n* Age ≥ 18 years, with no gender restriction;\n* Patients with MZL requiring systemic therapy, including but not limited to:\n\n  1. Gastric extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma), HP-positive or HP-negative, with progression\u002Frelapse after local therapy (including surgery, radiotherapy, and anti-Helicobacter pylori treatment);\n  2. Non-gastric MALT lymphoma:\n\n     Patients with Ann Arbor Stage I-II disease with progression\u002Frelapse after local therapy (including surgery, radiotherapy, etc.); Patients with newly diagnosed Ann Arbor Stage III-IV disease meeting the GELF criteria as recommended by the NCCN Guidelines;\n  3. Splenic marginal zone lymphoma (SMZL):\n\n     Patients with progression\u002Frelapse after local therapy (including splenectomy, antiviral therapy in HCV-positive patients, etc.); Or newly diagnosed with: progressive or painful splenomegaly, symptomatic or progressive cytopenia, defined as Hb \\\u003C 100 g\u002FL, PLT \\\u003C 80 × 10⁹\u002FL, or absolute neutrophil count (ANC) \\\u003C 1.0 × 10⁹\u002FL;\n  4. Nodal marginal zone lymphoma (NMZL):\n\nPatients with Ann Arbor Stage I-II disease with progression\u002Frelapse after local therapy (including surgery, radiotherapy, etc.); Patients with newly diagnosed Ann Arbor Stage III-IV disease meeting the GELF criteria as recommended by the NCCN Guidelines;\n\n* ECOG performance status 0, 1, or 2 (Appendix 4);\n* Adequate general condition, with a life expectancy \\> 3 months;\n* Adequate bone marrow function (except for cytopenia caused by the underlying disease), liver function, and renal function;\n* Commitment to comply with study procedures and cooperate throughout the entire study period;\n* The patient or his\u002Fher legally authorized representative must provide written informed consent prior to any study-specific tests or procedures;\n* For women of childbearing potential: agreement to use adequate contraceptive measures during study treatment and for at least 1 year after treatment completion.Men must agree to practice abstinence or use barrier contraception.\n\nExclusion Criteria:\n\n* Histological transformation to high-grade lymphoma.\n* Known central nervous system (CNS) involvement by lymphoma or evidence of CNS disease.\n* Prior systemic therapy, including immunotherapy, chemotherapy, or targeted therapy.\n* Prior autologous stem cell transplantation, or allogeneic tissue \u002F solid organ transplantation.\n* History of other invasive malignancies that were not treated with curative intent or for which anticancer treatment (including hormone therapy for breast or prostate cancer) was administered within the past 3 years.\n* Presence of uncontrolled cardiovascular or cerebrovascular diseases (e.g., New York Heart Association class III or IV heart failure, arrhythmia, myocardial infarction, stroke, or intracranial hemorrhage), coagulation disorders, connective tissue diseases, severe infectious diseases (including active tuberculosis), or other similar conditions.\n* Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result by polymerase chain reaction \\[PCR\\]).Seropositivity is permitted; patients with HBV DNA \\\u003C 10³ IU\u002FmL may be enrolled. HCV RNA must be negative.\n* Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment.Receipt of live attenuated vaccines, including influenza vaccines, is prohibited during the study period.\n* Requirement for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers.",{"count":55,"type":21},131,"2 Years","OBSERVATIONAL","This is a multicenter, real-world study on first-line CD20 monoclonal antibody-based regimens for treatment-naive marginal zone B-cell lymphoma based on risk stratification. The primary objective is to evaluate the efficacy and safety of the \"BR\", \"R2\", and \"OR2\" treatment regimens in treatment-naive MZL patients receiving first-line CD20 monoclonal antibody-based therapy stratified by risk.",[33],"NOT_YET_RECRUITING","2026-03-19",{"date":63,"type":38},"2026-03-25",{"date":65,"type":21},"2026-04",{"date":67,"type":21},"2028-02",{"name":69,"class":70},"Henan Cancer Hospital","OTHER_GOV",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":46},"100555301","phase-2-rituximab-plus-venetoclax-in-front-line-marginal-zone-lymphoma-100555301","NCT06510309","Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma","A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Participants must have histologically confirmed Marginal Zone Lymphoma\n* Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm or spleen \\> 13 cm\n* Patients with intestinal MALT lymphoma must have disease that is detectable by EGD or colonoscopy with biopsy\n* Patients with gastric MALT lymphoma must be h. pylori negative. Patients who are h. pylori positive are allowed if they have failed a trial of h. pylori eradication\n* Patients with gastric MALT lymphoma who are h. pylori negative or who relapsed\u002Frefractory disease after h. pylori eradication must be ineligible form have refused or failed gastric radiation therapy\n* Age ≥18 years\n* ECOG performance status ≤1\n* Life expectancy of greater than 2 years\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Hemoglobin ≥8.0 g\u002FdL\n  * absolute neutrophil count ≥1,000 cells\u002FmcL (In the event of documented bone marrow involvement, ANC must be ≥1500 cells\u002FmcL)\n  * platelets ≥50,000 cells\u002Fmm3\n  * total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (In patients with Gilberts disease or documented liver involvement, total bilirubin \\\u003C 3 X ULN will be allowed)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 3 × institutional ULN unless elevation is caused by liver involvement with MZL\n  * Creatinine within institutional ULN OR creatinine clearance \\>60mL\u002Fmin for patients with creatinine levels above institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine clearance measurements)\n* Ability to understand and the willingness to sign a written informed consent document\n* Patient must be able to swallow pills\n* HIV-positive patients on combination antiretroviral therapy are eligible if their HIV is under adequate control with an antiretroviral regimen that has been stable for \\> 4 weeks, as long as the CD4 count is \\>300. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated\n* Patients with Hepatitis B surface antibody serum positivity due to poor immunization, as well as those with Hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible\n\nExclusion Criteria:\n\n* Patients who had prior systemic therapy including rituximab\n* Patients who have had prior radiation therapy, with the following exceptions:\n\n  * Palliative radiotherapy (RT) is allowed, but must be completed at least 1 week prior to treatment on this study, and prior to any baseline imaging studies or biopsies. Patients must meet criteria for measurable\u002Fassessable disease as outlined above after completion of RT.\n  * Prior RT for gastric MALT is allowed, but must be completed at least 1 week prior to treatment on this study, and prior to any baseline imaging studies or biopsies. Patients must meet criteria for measurable\u002Fassessable disease as outlined above after completion of RT.\n* Prior treatment with ibrutinib or other BTK inhibitor\n* Patients with h. pylori-associated gastric MALT or stage I\u002FII MZL will be excluded unless they are deemed to be unfit for radiation therapy with curative intent.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with uncontrolled hepatitis B or C or HIV infection are ineligible defined as patients with positive serologies and a detectable viral load by PCR.\n* Patients with Hep B core ab positivity are allowed provided Hep B PCR is undetectable\n* Pregnant women or participants unwilling to adhere to institutional guidelines for highly effective contraception for 12 months after the last dose of rituximab are excluded from this study because of documented risks of rituximab on fetal immunologic development and unknown effects of venetoclax on embryonic development. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued.\n* Received moderate or strong CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of venetoclax.\n* Received moderate or strong CYP3A inducers (such as rifampin, carbamazepine, phenytoin, St. John's Wort) within 7 days prior to the first dose of venetoclax.",{"count":79,"type":21},33,[25],"The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating participants with untreated Marginal Zone Lymphoma (MZL).\n\nThe names of the study drugs involved in this study are:\n\n* Venetoclax (a type of inhibitor)\n* Rituximab (a type of antibody)",[83,84,33],"Lymphoma","Marginal Zone Lymphoma",[83,84,33],"2026-03-12",{"date":88,"type":38},"2026-03-13",{"date":90,"type":38},"2026-02-11",{"date":92,"type":21},"2031-10-01",{"name":94,"class":45},"Gottfried von Keudell, MD PhD",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":46},"100628282","phase-2-efficacy-and-safety-of-lisaftoclax-apg-2575-monotherapy-in-patients-with-indolent-lymphoma-100628282","NCT07459608","Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Indolent Lymphoma","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Histologically confirmed diagnosis of an indolent lymphoma (CLL\u002FWM\u002FMZL), meeting one of the following conditions:\n\n   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.).\n\n   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.).\n3. Adequate bone marrow function, defined as:\n\n   1. Hemoglobin (Hb) ≥ 70 g\u002FL (without transfusion support within 7 days prior to the first dose of study drug).\n   2. Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹\u002FL (independent of growth factor support within 7 days prior to the first dose of study drug).\n   3. Platelet count ≥ 50 × 10⁹\u002FL (without transfusion support within 7 days prior to the first dose of the study drug. If the patient has documented bone marrow involvement, a platelet count ≥ 30 × 10⁹\u002FL is acceptable, provided the investigator ensures adequate supportive care).\n4. Adequate hepatic and renal function, defined as:\n\n   1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).\n   2. Creatinine clearance (Ccr) ≥ 40 ml\u002Fmin (estimated by the Cockcroft-Gault formula).\n   3. Total bilirubin \\\u003C 1.5 × ULN.\n5. Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN, 50%).\n6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 3.\n7. Life expectancy ≥ 3 months.\n8. 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\u002Finjections\u002Foral 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.\n9. No other active malignant disease within the past 3 years, except for currently treated basal cell\n\nExclusion Criteria:\n\n1. Prior treatment with any B-cell lymphoma 2 (BCL-2) inhibitor.\n2. Patients with active infection (including active hepatitis B virus \\[HBV\\] or hepatitis C virus \\[HCV\\] infection, or human immunodeficiency virus \\[HIV\\] positivity) or any other serious uncontrolled medical condition (Patients who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) seropositive are eligible if their HBV DNA is below the lower limit of detection\u002Fquantification and they are willing to undergo monthly HBV reactivation monitoring. Patients who are HCV antibody positive are eligible if their HCV RNA is below the lower limit of detection\u002Fquantification).\n3. Presence of other concurrent malignancies (except for those specified in the inclusion criteria) that may affect the interpretation of study results or treatment with the investigational drug, or patients with severe coagulation disorders, or severe impairment of cardiac, cerebral, pulmonary, hepatic, or renal function.\n4. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 12 months prior to the first dose of the study drug.\n5. Administration of any live vaccine within 28 days prior to the first dose of the study drug.\n6. Women of childbearing potential (WOCBP) or men with partners of childbearing potential who are unwilling to use highly effective contraception; pregnant or breastfeeding women.\n7. Inability to swallow tablets, or presence of malabsorption syndrome, any disease significantly affecting gastrointestinal function, gastrectomy\u002Fsmall bowel resection, symptomatic inflammatory bowel disease or ulcerative colitis, or partial\u002Fcomplete bowel obstruction.\n8. Known hypersensitivity to the active pharmaceutical ingredient, excipients of the study drug, or its analogs.\n9. Requirement for concomitant treatment with strong inhibitors or inducers of cytochrome P450 (CYP) 3A.\n10. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's judgment, could compromise the patient's safety or pose an undue risk for study participation.",{"count":102,"type":21},75,[25],"This is a multicenter, prospective, single-arm phase II study designed to evaluate the safety and efficacy of lisaftoclax (APG-2575), an oral selective BCL-2 inhibitor, in patients with indolent B-cell lymphomas. The study will enroll adult patients with chronic lymphocytic leukemia (CLL), Waldenström macroglobulinemia (WM), or marginal zone lymphoma (MZL) who are either treatment-naïve but considered ineligible for Bruton tyrosine kinase (BTK) inhibitor therapy due to significant comorbidities, or who are intolerant to prior BTK inhibitor treatment.\n\nEligible patients will receive oral lisaftoclax once daily with a dose ramp-up to a target dose of 600 mg in 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned treatment period. The primary objective is to evaluate the safety and tolerability of lisaftoclax monotherapy, while secondary objectives include assessment of antitumor activity, including overall response rate (ORR), complete response (CR) rate, minimal residual disease (MRD) negativity, progression-free survival (PFS), duration of response (DOR), and overall survival (OS). Quality of life will also be assessed using the EORTC QLQ-C30 questionnaire.",[106,32,33,107],"Indolent Lymphoma","CLL \u002F SLL","2026-03-11",{"date":88,"type":38},{"date":111,"type":21},"2026-03-10",{"date":113,"type":21},"2028-03-01",{"name":69,"class":70}]