[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cll--sll\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cll--sll":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,78,106,140,164],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100619273","phase-3-rocket-cll-global-phase-3-study-rocbrutinib-vs-pirtobrutinib-in-cbtki-pretreated-rr-cllsll-100619273",false,"NCT07342478","ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R\u002FR CLL\u002FSLL","A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) \u002F Small Lymphocytic Lymphoma (SLL) Subjects","Inclusion Criteria:\n\n* Age ≥18 years;\n* Histologically confirmed CLL\u002FSLL iwCLL 2018;\n* Relapsed or refractory disease requiring treatment;\n* Previously treated with prior lines of therapy including a covalent BTK inhibitor;\n* Measurable disease;\n* ECOG 0-2;\n* Adequate marrow, hepatic, and renal function;\n* TP53 mutation status confirmed by NGS;\n* 17p deletion status confirmed by FISH;\n\nExclusion Criteria:\n\n* Prior ncBTKi or BTK degraders;\n* Richter's transformation;\n* Confirmed prolymphocytic leukemia;\n* Uncontrolled comorbidities or infections;\n* Known CNS involvement by CLL\u002FSLL;\n* Prior malignancy requiring active treatment (except certain adequately treated cancers) per protocol;\n* Pregnancy or breastfeeding;\n* Concomitant medications or conditions prohibited by protocol (e.g., strong drug-drug interaction risk);","ALL","18 Years",{"count":19,"type":20},306,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase 3, randomized, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received a covalent Bruton's tyrosine kinase inhibitor (cBTKi). Approximately 306 participants will be randomized 1:1 to receive rocbrutinib 200 mg orally once daily or pirtobrutinib 200 mg orally once daily, administered continuously in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. Randomization will be stratified by presence of del(17p)\u002FTP53 mutation (yes\u002Fno), reason for discontinuation of prior cBTKi therapy (toxicity vs disease progression), prior exposure to a BCL2 inhibitor (yes\u002Fno), and region (United States\u002FChina\u002Frest of world). The primary endpoint is progression-free survival (PFS) assessed by an independent review committee (IRC) using iwCLL 2018 criteria for CLL and Lugano 2014 criteria for SLL. Key secondary objectives include overall survival, overall response rate, time-to-event outcomes, and safety\u002Ftolerability; exploratory objectives include health-related quality of life and biomarker assessments.",[26,27,28,29,30,31,32,33],"CLL \u002F SLL","CLL (Chronic Lymphocytic Leukemia)","CLL, Refractory","CLL, Relapsed","SLL (Small Lymphocytic Lymphoma)","SLL","CLL","CLL Progression",[35,36,37,38,39,40,41,42,32,31,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64],"Rocbrutinib","LP-168","Pirtobrutinib","Jaypirca","Phase 3","Randomized","Open-label","Relapsed or refractory","CLL\u002FSLL","Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Covalent BTK inhibitor pretreated","cBTKi pretreated \u002F cBTKi-exposed","BTK inhibitor","Non-covalent BTK inhibitor","Next-generation BTKi","Dual-binding BTKi","Fourth-generation BTKi","Oral once daily","Progression-free survival","PFS","Independent review committee","IRC-assessed","iwCLL 2018","Lugano 2014","del(17p)","TP53 mutation","Prior BCL2 inhibitor exposure","eason for prior BTKi discontinuation (progression vs intolerance)","Global","RECRUITING","2026-08-07",{"date":68,"type":69},"2026-08-11","ACTUAL",{"date":71,"type":69},"2026-04-23",{"date":73,"type":20},"2030-07-30",{"name":75,"class":76},"Newave Pharmaceutical Inc","INDUSTRY",6,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100650312","phase-2-pirtobrutinibsonrotoclaxps-regimen-in-the-treatment-of-b-cell-lymphoma-100650312","NCT07744750","Pirtobrutinib+Sonrotoclax（PS) Regimen in the Treatment of B-Cell Lymphoma","A Prospective, Phase II, Multicenter Clinical Study of Pirtobrutinib Combined With Sonrotoclax Regimen in the Treatment of B-Cell Lymphoma","Inclusion Criteria:\n\n* Cohort 1: Histologically transformed DLBCL\n\n  1. Histopathologically confirmed histologically transformed DLBCL, including transformation from indolent lymphomas such as CLL, WM, FL, and MZL.\n  2. Whole-body PET\u002FCT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion in two perpendicular dimensions (longest diameter \\>15 mm for nodal lesions, or longest diameter \\>10 mm for extranodal lesions).\n  3. Except patients with Richter transformation, patients transformed from MZL, FL, WM, etc., must have received at least one line of systemic anti-lymphoma therapy either during the indolent phase or after transformation.\n\nCohort 2: Relapsed\u002Frefractory CLL\u002FSLL\n\n1. Histopathologically confirmed relapsed\u002Frefractory CLL\u002FSLL.\n2. Disease relapse or refractoriness after at least one line of systemic anti-lymphoma therapy, which may include a BTK inhibitor.\n\nCohort 3: Relapsed\u002Frefractory MZL\n\n1.Histopathologically confirmed relapsed\u002Frefractory MZL. 2.Received systemic therapy containing an anti-CD20 monoclonal antibody or a BTK inhibitor.\n\n3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. 4.Age ≥ 18 years. 5.Adequate organ and bone marrow function defined as follows:\n\n1. Hematologic function (assessed within 7 days prior to Cycle 1 Day 1 \\[C1D1\\]): a. Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹\u002FL. Patients with values below this threshold may be eligible if there is documented bone marrow involvement impairing hematopoiesis. b. Platelet count ≥ 50 × 10⁹\u002FL without transfusion support. Patients with values below this threshold may be eligible if there is documented bone marrow infiltration impairing hematopoiesis. c. If transfusions are administered to treat thrombocytopenia or anemia, the patient must demonstrate a response to transfusion support.\n2. Coagulation function: Activated partial thromboplastin time (aPTT), prothrombin time (PT), or international normalized ratio (INR) ≤ 1.5 × upper limit of normal (ULN).\n3. Hepatic function: Serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n4. Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 30 mL\u002Fmin.\n5. Cardiac function: New York Heart Association (NYHA) functional class less than Class III; ejection fraction ≥ 50% on echocardiogram.\n\n6.Estimated survival \\> 3 months. 7.Able to provide written informed consent and comply with protocol-specified study visits and procedures.\n\n8.Female subjects of childbearing potential, or male subjects whose female partners are of childbearing potential, must utilize effective contraceptive measures throughout the treatment period and for 90 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. DLBCL with central nervous system or leptomeningeal involvement;\n2. Prior treatment with a non-covalent BTK inhibitor;\n3. Prior treatment with immune checkpoint inhibitors;\n4. Contraindication or hypersensitivity to any drug in the combination treatment regimen;\n5. Concurrent other malignancies requiring treatment or intervention;\n6. Major surgery within 4 weeks prior to treatment (excluding vascular access catheterization or biopsy);\n7. Any life-threatening disease, medical condition or organ dysfunction that, in the Investigator's opinion, may compromise patient safety or compliance with study procedures;\n8. Uncontrolled clinical cardiac signs or diseases, including: i. Heart failure of NYHA Class ≥ II ii. Unstable angina pectoris iii. Myocardial infarction within the past 12 months iv. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n9. Patients with active bleeding;\n10. Active and uncontrolled systemic bacterial, viral, fungal or parasitic infection (excluding fungal nail infection), or other clinically significant active disease process rendering the patient unsuitable for trial participation as judged by the Investigator.\n11. Patients with active chronic hepatitis B or active hepatitis C. Patients positive for Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb), or Hepatitis C virus (HCV) antibody at screening must undergo further Hepatitis B virus (HBV) DNA testing (≤2500 copies\u002FmL or ≤500 IU\u002FmL) to rule out active hepatitis B or active hepatitis C requiring treatment before enrollment. Nevertheless, eligible patients with positive HBsAg and\u002For HBcAb must receive anti-hepatitis B antiviral therapy.\n12. Patients infected with Human Immunodeficiency Virus (HIV) and\u002For patients with acquired immunodeficiency syndrome (AIDS);\n13. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect absorption of the study drug;\n14. Pregnant or lactating women;\n15. Patients with psychiatric disorders or those unable to provide informed consent;\n16. Patients deemed unsuitable for participation in this study by the Investigator.",{"count":86,"type":20},40,[88],"PHASE2","This prospective, open-label, Phase II clinical trial evaluates the efficacy and safety of pirtobrutinib combined with sotoclax across three distinct B-cell lymphoma cohorts: histologically transformed diffuse large B-cell lymphoma (DLBCL), relapsed\u002Frefractory chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL), and relapsed\u002Frefractory marginal zone lymphoma (MZL). Dosing regimen ：pirtobrutinib 200 mg orally once daily plus sotoclax with a 4-week dose escalation schedule (1, 2, 5, 10, 20, 40, 80, 160 mg\u002Fday, then 320 mg\u002Fday on days 1-28, starting Cycle 2) administered orally. Cohorts 1 and 2 additionally incorporate obinutuzumab 1000 mg intravenously on Cycle 1 days 1, 8, and 15, followed by days 1 of Cycles 2 through 6, with a maximum of six cycles. Each treatment cycle spans 28 days.\n\nFor Cohort 1 (RT DLBCL), the primary objective centers on early response assessment following three cycles of the PSO regimen (pirtobrutinib-sotoclax-obinutuzumab), with PET\u002FCT evaluation serving as the critical decision point. Patients demonstrating progressive disease or stable disease discontinue study treatment, while those achieving complete or partial response may proceed to investigator-selected bridging therapies including bispecific antibodies, CAR-T cell therapy, or hematopoietic stem cell transplantation, or alternatively continue PSO combination therapy. Obinutuzumab is capped at six cycles, whereas pirtobrutinib and sotoclax may continue for up to 25 cycles. Comprehensive biomarker strategies include ctDNA analysis from peripheral blood at baseline and after Cycle 1 (following full-dose sotoclax exposure), with serial assessments at Cycles 3, 7, 14, and every six cycles during Year 2 for patients continuing PSO beyond Cycle 3. Patients with measurable baseline tumor cells in peripheral blood or bone marrow undergo flow cytometry-based MRD detection at 10-⁴ sensitivity at corresponding timepoints. T-cell subset and functional analyses are performed at baseline, Cycle 3, and every three cycles thereafter to characterize immune dynamics during treatment.\n\nCohort 2 (relapsed\u002Frefractory CLL\u002FSLL) follows a continuous treatment paradigm without an early stopping rule, with efficacy assessment after fourteen cycles. Patients achieving complete remission with MRD negativity at 10-⁴ may elect treatment discontinuation. Sotoclax is administered for a maximum of twenty-four cycles, with pirtobrutinib maintenance for patients failing to achieve MRD-negative complete remission. The biomarker program incorporates both flow cytometry MRD at 10-⁴ and next-generation sequencing MRD at 10-⁶ sensitivity, providing unprecedented depth of residual disease characterization. Sampling occurs at baseline, Cycle 1, Cycle 3, Cycle 7, Cycle 14, and every six cycles in Year 2.\n\nCohort 3 (relapsed\u002Frefractory MZL) mirrors the CLL\u002FSLL treatment structure but omits obinutuzumab, testing the doublet of pirtobrutinib plus sotoclax. The fourteen-cycle efficacy assessment and MRD-guided stopping rule apply identically, with sotoclax limited to twenty-four cycles and pirtobrutinib maintenance for non-responders. ctDNA surveillance occurs at baseline, Cycle 3, Cycle 7, Cycle 14, and every six cycles in Year 2, complemented by serial T-cell immunophenotyping.",[91,92,26,93],"DLBCL - Diffuse Large B Cell Lymphoma","Richter Transformation","MZL","NOT_YET_RECRUITING","2026-08-04",{"date":97,"type":69},"2026-08-06",{"date":99,"type":20},"2026-08-30",{"date":101,"type":20},"2029-08-31",{"name":103,"class":104},"Changzhou No.2 People's Hospital","OTHER",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":5},"100570565","phase-1-a-study-of-lonitoclax-ze50-0134-in-relapsed-or-refractory-b-cell-malignancies-100570565","NCT06708897","A Study of Lonitoclax (ZE50-0134) in Relapsed or Refractory B-cell Malignancies","Phase 1 Study of Lonitoclax (ZE50-0134) in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas","Inclusion Criteria:\n\n1. Men and women aged 18 years or older.\n2. Disease as defined below:\n\n   * Part 1: Relapsed or refractory CLL or SLL, as defined by iwCLL, after at least 2 prior therapies that included a covalent Bruton tyrosine kinase inhibitor (BTKi) and venetoclax, or after the participant declined venetoclax; or progressive low-grade lymphoma, including marginal zone lymphoma or lymphoplasmacytic lymphoma (including Waldenstrom macroglobulinemia), after at least 1 prior therapy that included either a BTKi or CD20 antibody-based therapy.\n   * Part 2: Relapsed or refractory CLL or SLL, as defined by iwCLL, after at least 1 prior therapy that included a BTKi; participants must be venetoclax naive.\n3. Disease requiring therapy in the investigator's opinion.\n4. Adequate bone marrow, liver, and renal function during screening:\n\n   * Absolute neutrophil count greater than 0.75 x 10\\^9\u002FL; for participants with documented bone marrow involvement, at least 0.5 x 10\\^9\u002FL.\n   * Platelet count greater than 50 x 10\\^9\u002FL; for participants with documented bone marrow involvement, at least 30 x 10\\^9\u002FL.\n   * AST and ALT no greater than 3.0 times the upper limit of normal.\n   * Total bilirubin no greater than 1.5 times the upper limit of normal. Participants with suspected or known Gilbert disease may have total bilirubin up to 3 times the upper limit of normal if predominantly unconjugated.\n   * Creatinine- or cystatin C-based glomerular filtration rate at least 60 mL\u002Fmin, or at least 40 mL\u002Fmin with a normal urine neutrophil gelatinase-associated lipocalin level. Estimated GFR is calculated using the Modification of Diet in Renal Disease formula.\n5. Eastern Cooperative Oncology Group performance status of 0, 1, or 2.\n6. For women of childbearing potential, a negative serum or urine pregnancy test within 7 days before the first dose and a negative result before each treatment cycle. Pregnancy testing is not required for women older than 50 years with at least 12 months of amenorrhea; women aged 50 years or younger with at least 6 months of spontaneous amenorrhea and follicle-stimulating hormone greater than 40 mIU\u002FmL; or permanently sterilized women, including hysterectomy, bilateral salpingectomy, or uterine ablation.\n7. Women and men of reproductive potential must agree to use highly effective contraception from signing informed consent until 90 days after the last dose of study drug.\n8. Ability to understand and willingness to sign written informed consent, including consent for genetic biomarker analyses from tissue and plasma, before study-specific procedures.\n\nExclusion Criteria:\n\n1. Part 2 only: Prior venetoclax treatment.\n2. Known active Richter transformation. Participants previously treated for Richter transformation may be eligible if they have been in remission for more than 2 years, have no evidence of Richter transformation, and have CLL only.\n3. Known hypersensitivity to lonitoclax, its excipients, or an agent administered in association with the study.\n4. Clinically significant cardiac disease, including congestive heart failure greater than New York Heart Association Class II; uncontrolled coronary artery disease; unstable angina; new-onset angina or myocardial infarction within 6 months before first dose; major regional wall-motion abnormalities on baseline echocardiography; or cardiac arrhythmias requiring antiarrhythmic treatment other than beta-blockers or digoxin.\n5. Known active cytomegalovirus, hepatitis B virus, or hepatitis C virus infection.\n6. HIV-positive disease that is not adequately controlled by antiviral therapy. Participants with adequately controlled HIV may enroll.\n7. Known active SARS-CoV-2 infection. Prior infection is allowed if the participant completely recovered more than 14 days previously.\n8. Active clinically serious infection of Grade greater than 2 requiring parenteral therapy. Participants may be eligible after the infection resolves.\n9. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days before enrollment.\n10. Allogeneic bone marrow transplant within 4 months before first dose. Immunosuppressive therapy related to the transplant must be completed before enrollment.\n11. Active cancer that limits expected survival to less than 2 years or requires anticancer therapy concomitantly with study treatment. Exceptions may include resected localized skin, breast, or prostate cancer and malignancies treated with hormonal or immune therapies alone; secondary cancers should be discussed with the Medical Monitor.\n12. Physical examination or laboratory finding that contraindicates investigational therapy or otherwise places the participant at excessively high treatment risk in the investigator's opinion.\n13. Requirement for ongoing immunosuppressive therapy, including systemic corticosteroids, for cancer or another condition. Topical or inhaled corticosteroids and low-dose systemic steroids of no more than 20 mg prednisone equivalent per day are permitted for comorbid conditions. Short courses above this dose before first dose and during Week 1 may be used for tumor flare.\n14. Major surgery or significant trauma within 4 weeks before first dose.\n15. Breastfeeding. Breastfeeding must be discontinued before and during treatment and for at least 3 months after treatment ends.\n16. QT interval corrected using Fridericia's formula greater than 470 milliseconds that cannot be corrected with electrolyte replacement, hydration, or medication modification. This criterion does not apply to participants with a pacemaker.",{"count":114,"type":20},84,[116],"PHASE1","This Phase 1, open-label, multicenter study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of lonitoclax (ZE50-0134) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and select low-grade B-cell lymphomas.\n\nThe study has two sequential parts. Part 1 uses dose escalation to determine the biologically effective dose and\u002For maximum tolerated dose of lonitoclax. Participants receive a 3-day step-up regimen followed by continuous once-daily or twice-daily oral dosing in 28-day cycles. Part 2 is a randomized dose-expansion comparison of two selected lonitoclax dose levels in venetoclax-naive participants with relapsed or refractory CLL\u002FSLL. Treatment may continue for up to 12 cycles and, for participants deriving clinical benefit, for up to 24 cycles with approval from the Medical Monitor.",[26,27,30,119,120],"Marginal Zone Lymphoma(MZL)","Lymphoplasmacytic Lymphoma\u002FWaldenström Macroglobulinemia",[122,123,124,125,126,127,128,48,129,130],"Lonitoclax","ZE50-0134","BCL2 inhibitor","relapsed or refractory","dose escalation","dose expansion","dose optimization","venetoclax","tumor lysis syndrome","2026-07-30",{"date":133,"type":69},"2026-07-31",{"date":135,"type":69},"2025-04-08",{"date":137,"type":20},"2028-07",{"name":139,"class":76},"Lomond Therapeutics Holdings, Inc.",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":105},"100628282","phase-2-efficacy-and-safety-of-lisaftoclax-apg-2575-monotherapy-in-patients-with-mature-b-cell-lymphoma-100628282","NCT07459608","Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Mature B-cell Lymphoma","Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Mature B-cell Lymphomas","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.\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":148,"type":20},75,[88],"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.",[152,153,93,26],"Indolent Lymphoma","WM","2026-07-27",{"date":156,"type":69},"2026-07-29",{"date":158,"type":20},"2026-07-10",{"date":160,"type":20},"2028-03-01",{"name":162,"class":163},"Henan Cancer Hospital","OTHER_GOV",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100645345","phase-2-zanubrutinib-induction-followed-by-delayed-fixed-duration-combination-with-sonrotoclax-for-cllsllstop-trial-20-100645345","NCT07682415","Zanubrutinib Induction Followed by Delayed Fixed-Duration Combination With Sonrotoclax for CLL\u002FSLL：Stop Trial 2.0","A Single-arm, Multicenter, Prospective Phase II Clinical Trial of Delayed Fixed-duration Combination With Sotoraclax Following Zanubrutinib Induction in Patients With CLL\u002FSLL: Stop Trial 2.0","ZS","Inclusion Criteria:\n\n1. Aged ≥18 years, no restriction on gender.\n2. Newly diagnosed chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL) consistent with the Chinese Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (2025 Edition).\n3. Meet at least one of the following indications for CLL treatment:\n\n   1. Evidence of progressive bone marrow failure manifested by progressive reduction in hemoglobin and\u002For platelet counts.\n   2. Massive splenomegaly (spleen palpable \\>6 cm below the left costal margin) or symptomatic splenomegaly.\n   3. Bulky lymphadenopathy (maximum diameter \\>10 cm) or symptomatic lymphadenopathy.\n   4. Progressive lymphocytosis: ≥50% increase in lymphocyte count within 2 months, or lymphocyte doubling time (LDT) \\\u003C6 months. LDT alone shall not serve as an indication for treatment if the baseline lymphocyte count is \\\u003C30×10⁹\u002FL.\n   5. Symptomatic organ dysfunction caused by CLL\u002FSLL (involving skin, kidney, lung, spine and other organs).\n   6. Autoimmune hemolytic anemia (AIHA) and\u002For immune thrombocytopenia (ITP) with inadequate response to corticosteroid therapy.\n   7. At least one of the following disease-related B symptoms:\n\n      * Unintentional weight loss ≥10% within the preceding 6 months without identifiable cause; ② Severe fatigue (ECOG performance status ≥2, inability to perform routine daily activities);\n\n        ③ Unexplained fever \\>38.0 °C lasting ≥2 weeks without confirmed infection;\n\n        ④ Unexplained night sweats persisting for more than 1 month without confirmed infection.\n4. ECOG performance status ≤2.\n5. Major organ function meets the following criteria within 7 days prior to treatment initiation:\n\n   ￮ Hematology: platelet count ≥30×10⁹\u002FL;\n\n   ￮ Biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; creatinine clearance ≥30 mL\u002Fmin;\n\n   ￮ Cardiac Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥lower limit of normal (50%).\n6. Male and female participants agree to use effective contraception throughout the study period and for a minimum of 4 weeks after treatment completion.\n7. Estimated life expectancy ≥6 months.\n8. The patient voluntarily participates in the trial and signs the written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Previously received any systemic anti-tumor therapy for CLL\u002FSLL. 2. Pathologically confirmed transformation to Richter's syndrome via biopsy. 3. Severe non-lymphoma-related hepatic or renal impairment defined as: ALT\u002FAST \\>3×ULN or TBIL \\>2×ULN; creatinine clearance \\\u003C30 mL\u002Fmin or serum creatinine \\>2×ULN.\n\n  4\\. Significant pre-existing renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular or hepatic disease judged by the investigator to compromise trial participation.\n\n  5\\. Other uncontrolled clinically significant medical conditions including but not limited to:\n\n  a. Uncontrolled systemic infection (viral, bacterial, fungal); positive hepatitis B surface antigen with HBV-DNA \\>1000 IU\u002FmL; positive anti-HCV antibody or detectable HCV-RNA; positive anti-HIV antibody.\n\n  b. Active uncontrolled autoimmune diseases other than autoimmune cytopenias. 6. Clinical signs of central nervous system (CNS) dysfunction or documented CNS infiltration by disease.\n\n  7\\. Received major surgery (excluding lymph node biopsy) within 14 days prior to enrollment or scheduled to undergo major surgery during trial treatment.\n\n  8\\. Inability to swallow capsules, malabsorption syndrome, or severe gastrointestinal disorders including prior gastrectomy, small bowel resection, symptomatic inflammatory bowel disease, ulcerative colitis, partial or complete intestinal obstruction.\n\n  9\\. Concurrent use of strong CYP3A inhibitors or inducers during study drug initiation and dose titration period.\n\n  10\\. Pregnant or breastfeeding females; females of childbearing potential without reliable contraceptive measures.\n\n  11\\. Clinically significant cardiovascular disease (NYHA cardiac functional class III\u002FIV); history of myocardial infarction, malignant arrhythmia (including QTc ≥480 ms), inadequately controlled hypertension (systolic BP ≥150 mmHg, diastolic BP ≥100 mmHg) or unstable angina within 6 months before enrollment.\n\n  12\\. Coagulopathy-related exclusion: long-term treatment with multiple high-dose anticoagulants with no possibility of short-term discontinuation; persistent uncontrolled active bleeding; or prior life-threatening irreversible bleeding events.\n\n  13\\. History of severe hypersensitivity to any active ingredient or excipient of the investigational product.\n\n  14\\. Systemic disorders that may impair patient compliance with trial requirements.",{"count":173,"type":20},60,[88],"The goal of this clinical trial is to learn if zanubrutinib induction followed by delayed fixed-duration combination with sonrotoclax works to treat previously untreated Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL). It will also learn about the safety of this combination regimen. The main questions it aims to answer are:Does this combination therapy achieve undetectable minimal residual disease (uMRD) in participants?What medical problems (adverse events) do participants have when taking zanubrutinib and sonrotoclax?Researchers will conduct a single-arm study to systematically evaluate the MRD clearance, efficacy, safety, and immune-related functions of this specific treatment sequence.Participants will:Low-risk group (without 17p deletion\u002FTP53 mutation): Take zanubrutinib monotherapy for 12 cycles, followed by combination zanubrutinib + sonrotoclax for 12 cycles, then discontinue treatment for observation.High-risk group (with 17p deletion\u002FTP53 mutation): Follow the same initial regimen (12 cycles monotherapy + 12 cycles combination), followed by zanubrutinib monotherapy maintenance until disease progression.Visit the clinic periodically for MRD assessment (via flow cytometry), efficacy evaluation (CT\u002FPET-CT, lab tests), and safety checks (physical exam, blood tests, ECG).Undergo immune function evaluation via peripheral blood samples to assess changes in T-cell counts and subsets.",[26],[178,179,180],"Zanubrutinib","Sonrotoclax","Chronic Lymphocytic Leukemia","2026-06-28",{"date":183,"type":69},"2026-07-02",{"date":185,"type":20},"2026-06-08",{"date":187,"type":20},"2034-08-01",{"name":189,"class":104},"Yi Shuhua",7]