[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangzhou Lupeng Pharmaceutical Company LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":213},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,71,94,124,147,168,191],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100643634","phase-2-a-study-of-lacutoclax-lp-108-in-patients-with-relapsedrefractory-cllsll-100643634",false,"NCT07609823","A Study of Lacutoclax (LP-108) in Patients With Relapsed\u002FRefractory CLL\u002FSLL","A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Lacutoclax (LP-108) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n1. Patients with confirmed R\u002FR CLL\u002FSLL according to the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.\n2. Patients who had previously received standard therapy, experienced disease progression following the most recent line of treatment (excluding intolerance), and had at least one indication for treatment prior to enrollment.\n3. Have at least one measurable lesion.\n4. Age ≥18 years, regardless of sex.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n6. Life expectancy ≥ 12 weeks.\n7. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.\n8. Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.\n9. Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of Lacutoclax. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose of Lacutoclax.\n10. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to Lacutoclax or any of its excipients.\n2. Prior treatment with a BCL-2 family inhibitor.\n3. History of or currently suspected Richter's syndrome.\n4. Known or suspected central nervous system (CNS) involvement.\n5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.\n6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.\n7. Received corticosteroids for antitumor purposes, herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.\n8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to dosing.\n9. Prior malignancy other than CLL\u002FSLL within the past 2 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.\n10. Major cardiovascular or cerebrovascular events within 6 months prior to the first dose of study treatment.\n11. Presence of any severe and\u002For uncontrolled systemic disease.\n12. Impaired cardiac function.\n13. Any uncontrolled systemic infection.\n14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.\n15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, or sensitive CYP2C8 substrates during the study period.\n16. Primary autoimmune disease requiring immunosuppressive therapy.\n17. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.","ALL","18 Years",{"count":19,"type":20},75,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of Lacutoclax, an oral selective BCL-2 inhibitor, in patients with relapsed or refractory chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL). Lacutoclax is a potent and selective BCL-2 inhibitor with relatively weaker inhibitory activity against BCL-XL and BCL-W. Preliminary clinical data have demonstrated promising efficacy and an acceptable safety profile in patients with CLL\u002FSLL and other B-cell non-Hodgkin lymphomas (B-NHLs). This is an open-label, single-arm, multicenter Phase II study evaluating the efficacy and safety of oral Lacutoclax tablets in patients with relapsed or refractory CLL\u002FSLL.",[26],"Relapsed\u002FRefractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma",[28,29,30],"chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL)","Bcl-2 inhibitor","Lacutoclax","NOT_YET_RECRUITING","2026-06-07",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":20},"2026-07-30",{"date":39,"type":20},"2029-09-30",{"name":41,"class":42},"Guangzhou Lupeng Pharmaceutical Company LTD.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100642551","phase-1-a-study-of-rocbrutinib-in-combination-with-lacutoclax-in-patients-with-b-cell-malignancies-100642551","NCT07609862","A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies","A Phase Ib\u002FII, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTK Inhibitor Rocbrutinib in Combination With BCL-2 Inhibitor Lacutoclax in Patients With B-Cell Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of sex.\n2. Ib: Histologically confirmed diagnosis of CLL\u002FSLL (per 2018 iwCLL criteria) or B-cell malignancies (per 2022 WHO classification), including: MCL, DLBCL, FL, and WM. Must have received at least one prior line of systemic therapy, with documented disease progression or intolerance.\n\n   II: For Treatment-naïve (TN) CLL\u002FSLL patients: Must meet iwCLL treatment indications and no prior systemic therapy. For R\u002FR CLL\u002FSLL patients: at least one prior systemic therapy with documented disease progression or intolerance.\n3. Have at least one measurable lesion.\n4. Phase Ib: ECOG performance status ≤1; phase II: ECOG performance status ≤2.\n5. Life expectancy ≥ 12 weeks.\n6. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.\n7. Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of study treatment. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose.\n8. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or intolerance to Rocbrutinib, Lacutoclax, or any of their excipients; prior treatment with any BCL-2 inhibitor; or prior treatment with both covalent and non-covalent BTK inhibitors.\n2. Use of systemic corticosteroids at doses equivalent to \\>20 mg\u002Fday of prednisone for ≥3 days within 7 days prior to the first dose.\n3. History of or currently suspected Richter's syndrome.\n4. Known or suspected central nervous system (CNS) involvement.\n5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.\n6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.\n7. Received herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.\n8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to prior to the first dose.\n9. History of other active malignancies within the past 3 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.\n10. Any severe and\u002For uncontrolled systemic disease, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.\n11. Any of the following events within 6 months prior to the first dose: Symptomatic arrhythmia, myocardial infarction, intracranial hemorrhage, or Stroke.\n12. Impaired cardiac function.\n13. Any uncontrolled systemic infection.\n14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.\n15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, P-gp (P-glycoprotein) inhibitors, sensitive substrates of OATP1B3 or CYP2C8 during the study period.\n16. Received vaccination with any live-attenuated vaccines within 4 weeks prior to the first dose of study treatment.\n17. Evidence of an active bleeding constitution or a history of significant hemorrhagic disorders.\n18. Requirement for ongoing therapy with warfarin or other vitamin K antagonists.\n19. Presence of an active, uncontrolled, or symptomatic autoimmune disease that requires systemic treatment.\n20. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.",{"count":51,"type":20},92,[53,23],"PHASE1","BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib\u002FII clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.",[56,57,58,59,60],"Mantle Cell Lymphoma (MCL)","Diffuse Large B-Cell Lymphoma (DLBCL)","Follicular Lymphoma ( FL)","Waldenström Macroglobulinemia (WM)","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)",[62,63,64],"mature B-cell malignancies","BTK inhibitor","BCL-2 inhibitor",{"date":34,"type":35},{"date":67,"type":20},"2026-05-30",{"date":69,"type":20},"2033-05-30",{"name":41,"class":42},{"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":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100636771","phase-1-a-study-of-rocbrutinib-combined-with-r-gemox-in-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-100636771","NCT07570017","A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma","A Phase Ib Study to Evaluate the Safety and Efficacy of Rocbrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin (R-GemOx) in Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Patients with relapsed or refractory non-GCB DLBCL.\n* Have at least one measurable lesion according to the Lugano Response Criteria 2014.\n* ECOG performance status 0-2 (0-1 for dose escalation part).\n* Life expectancy ≥ 12 weeks.\n* Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.\n* No plan for autologous\u002Fallogeneic hematopoietic stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy.\n* Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.\n* All male subjects and female subjects of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male subjects must also avoid sperm donation during the above period. For women of childbearing potential, the result of serum pregnancy test must be obtained. Women must be non-lactating\n* Subjects must provide adequate tissue and blood samples for exploratory study. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.\n\nExclusion Criteria:\n\n* Intolerance to Rocbrutinib or any drug in the combination regimen.\n* Prior treatment with a BTK-targeted therapy; prior treatment with R-GemOx.\n* DLBCL transformed from an indolent lymphoma; diagnosis of high-grade or double-hit DLBCL.\n* Chemotherapy, biologic therapy (except CAR-T), immunotherapy or major surgery within 4 weeks of the first dose of study treatment.\n* Small molecule targeted therapy within 4 weeks or within 5 half-lives (whichever is shorter) of the first dose of study treatment.\n* Herbal or proprietary Chinese medicines with antitumor activity or radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment.\n* History of allogeneic hematopoietic stem-cell transplantation (allo-HSCT) or other organ transplantation, or autologous HSCT (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days of the first dose of study treatment.\n* Current corticosteroid therapy at a dose \\>20 mg\u002Fday prednisone equivalent. The prednisone-equivalent dose must have been stable for at least 4 weeks before Cycle 1 Day 1.\n* Unable to discontinue prohibited medications during the study period (strong or moderate CYP3A inhibitors or inducers, P-gp inhibitors, OATP1B3-sensitive substrates, warfarin or other vitamin K antagonists).\n* Known or suspected CNS involvement by lymphoma.\n* Presence of peripheral neuropathy \\> Grade 1.\n* Any severe and\u002For uncontrolled systemic disease, or condition affecting drug swallowing or absorption, that in the investigator's judgment makes the subject unsuitable for the study.",{"count":79,"type":20},42,[53],"This is a multicenter, open-label phase Ib study, evaluating the safety, tolerability, preliminary efficacy and PK characteristics of Rocbrutinib (LP-168) combined with R-GemOx in patients with R\u002FR non-GCB DLBCL. Study includes dose escalation part and dose expansion part. In the dose escalation part, a classic \"3+3\" design will be used to assess the safety of each specified dose combination. Upon completion of a predefined escalation part, the decision on whether to proceed to the dose expansion part will be based on the safety, PK, and efficacy data of the combination regimen.",[83],"DLBCL",[63,83,85],"R-GemOx","2026-04-29",{"date":88,"type":35},"2026-05-06",{"date":67,"type":20},{"date":91,"type":20},"2028-07-31",{"name":41,"class":42},2,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100621715","phase-1-a-study-evaluating-the-effects-of-itraconazole-or-rifampin-on-the-pharmacokinetic-characteristics-of-rocbrutinib-tablet-100621715","NCT07374224","A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet","A Phase I, Open-label, Two-part, Fixed-sequence Drug Interaction Study to Evaluate the Effects of Concomitant Use of the CYP3A4 Inhibitor Itraconazole or the CYP3A4 Inducer Rifampin on the Pharmacokinetics of Rocbrutinib in Healthy Subjects","Inclusion Criteria:\n\n* Subjects had no history of serious digestive system (such as inflammatory bowel disease, chronic diarrhea, Crohn's disease, autonomic dysfunction affecting gastric emptying), nervous system, cardiovascular system, genitourinary system, respiratory system, metabolic and endocrine system, musculoskeletal system, hematologic system diseases, or tumors\n* Subjects must agree to complete abstinence or use effective physical contraception (including sterilization, intrauterine device or barrier contraception) from the time of signing the informed consent form until 90 days after the last dose of medication, and have no plans to donate sperm or eggs during this period; if female subjects are using hormonal contraceptives, they must stop using them \\>14 days before the first dose and use at least one of the above contraceptive methods.\n* Must be between 18 and 45 years old (inclusive) and be male or female when signing the informed consent form.\n* Males weighing ≥50.0 kg or females weighing ≥45.0 kg, with a Body Mass Index (BMI) between 18.0 and 28.0 kg\u002Fm² (inclusive). BMI = weight (kg) \u002F height² (m²).\n* Able to understand and comply with the requirements of the research plan.\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Abnormalities in screening tests, such as vital signs, physical examination, or laboratory tests are clinically significant and may increase the risk of participants participating in the study or affect the scientific validity of the study.\n* Abnormal electrocardiogram or myocardial enzyme levels that are clinically significant as determined by a clinician include, but are not limited to: QTcF ≥ 450 ms (corrected using the Fridricia formula, QTcF = QT\u002FRR1\u002F3, RR = 60\u002FHR), etc.\n* The test results for at least one of the following are positive: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, and syphilis-specific antibody.\n* Patients who have taken the investigational drug within 4 weeks prior to or are required to take any drugs known to alter liver enzyme activity during the study period.\n* The patient must have used any systemic medications (including any vaccines, prescription drugs, over-the-counter drugs, and traditional Chinese medicines), special medical purpose foods, or health supplements within two weeks prior to taking the investigational drug.\n* Had consumed foods known to alter liver enzyme activity (such as grapefruit, star fruit, dragon fruit, and their fruit juices) and tobacco (including e-cigarettes) within one week prior to taking the investigational drug.\n* Consume any food or beverage containing caffeine, tea, alcohol, or xanthine within 24 hours prior to taking the investigational drug.\n* Difficulty swallowing or any condition that affects drug absorption, distribution, metabolism, or excretion.\n* Women with childbearing potential who have a positive pregnancy test result or who are currently breastfeeding.\n* Those with a history of smoking (smoking more than 5 cigarettes\u002Fday within 3 months prior to screening) or who tested positive for nicotine screening.\n* Those with a history of alcohol abuse (consuming more than 14 drinks per week, each drink equivalent to 360 ml of beer, 150 ml of wine, or 50 ml of spirits), or those who test positive for alcohol in a breathalyzer test.\n* Those with a history of drug abuse\u002Fuse, or who test positive in drug abuse screening.\n* Those with a known history of any allergic reaction requiring medication (including allergic reactions to drugs or food) or who have an allergic disease.\n* Individuals who have donated blood or lost ≥400 ml of blood within the three months prior to screening, or those who plan to donate blood during the study period and within three months after its completion, will be considered.\n* Those who have undergone surgery within the past 6 months or are expected to require surgery or hospitalization during the study period will be screened.\n* Candidates who have participated in other drug or medical device clinical trials within the three months prior to screening, or who plan to participate in other drug or medical device clinical trials during the study period, are eligible to be screened.\n* Subjects with special dietary requirements or who are expected to be unable to comply with the research center's dietary requirements during their hospitalization\n* The researchers believe that there are other circumstances that make the participants unsuitable to participate in this study.",true,"45 Years",{"count":104,"type":20},28,[53],"This is a phase I, open-label, two-part, fixed-sequence drug interaction study conducted to evaluate the effects of concomitant use of the potent CYP3A4 inhibitor itraconazole or the CYP3A4 inducer rifampin on the pharmacokinetics of Rocbrutinib in healthy subjects.",[108],"Clinical Pharmacology",[110,111,112,113],"drug interaction","Rocbrutinib","LP-168","CYP3A4","RECRUITING","2026-03-06",{"date":117,"type":35},"2026-03-09",{"date":119,"type":35},"2026-03-05",{"date":121,"type":20},"2026-08-30",{"name":41,"class":42},1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":93},"100621973","phase-3-a-study-of-rocbrutinib-versus-investigators-choice-of-btk-inhibitors-in-patients-with-relapsed-or-refractory-mantle-cell-lymphoma-100621973","NCT07377578","A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma","A Randomized, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study)","Inclusion Criteria:\n\n* Diagnosed with MCL, who have received at least one prior systemic regimen(s), and have experienced disease progression on the most recent line of therapy.\n* Have at least one measurable lesion according to the Lugano Response Criteria 2014.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.\n* Life expectancy ≥ 12 weeks.\n* Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function, etc.\n* Toxicities or complications from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.\n* All male subjects and female subjects of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male subjects must also avoid sperm donation during the above period. For women of childbearing potential, the result of serum pregnancy test must be obtained. Women must be non-lactating.\n* Subject voluntarily enrolls and signs the informed consent form, and agrees to comply with the study treatment plan and visit schedule.\n\nExclusion Criteria:\n\n* Hypersensitivity to Rocbrutinib or any study drug in the control group.\n* Prior treatment with any BTK-targeted therapy (except for intolerance).\n* Central nervous system (CNS) involvement by lymphoma.\n* History of other malignancy (except MCL) within the past 2 years, excluding radically cured skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, localized squamous cell carcinoma, etc.\n* History of major cardiovascular events within 6 months prior to randomization.\n* Presence of any severe and\u002For uncontrolled systemic disease that, in the investigator's judgment, or have poor cardiac function.\n* Uncontrolled active bacterial, fungal, or viral systemic infection, or active tuberculosis infection.\n* Any medical condition that could interfere with the absorption, distribution, metabolism, or excretion (ADME) of the investigational drug or the evaluation of study outcomes.",{"count":132,"type":20},394,[134],"PHASE3","Mantle cell lymphoma (MCL) is an aggressive yet often indolent type of B-cell non-Hodgkin lymphoma (NHL). Rocbrutinib (LP-168) is a novel, highly selective, fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that exhibits both covalent (irreversible) and non-covalent (reversible) binding. This unique dual mechanism of action has shown promising efficacy and a favorable safety profile across various B-cell NHL subtypes in prior Phase 1 and 2 studies. This is a Phase 3, randomized, open-label study comparing Rocbrutinib versus investigator's choice of BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) in patients with MCL who have received at least one prior line of therapy and are naïve to BTK inhibitor treatment (except for intolerance).",[137],"Mantle Cell Lymphoma",[137,63,111],"2026-02-04",{"date":141,"type":35},"2026-02-06",{"date":143,"type":35},"2026-02-05",{"date":145,"type":20},"2033-01-30",{"name":41,"class":42},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100607477","phase-2-a-study-of-rocbrutinib-in-participants-with-relapse-or-refractory-non-gcb-diffuse-large-b-cell-lymphoma-100607477","NCT07189065","A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma","An Open-Label, Randomized Controlled, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib Monotherapy Versus Investigator's Choice of Therapy in Patients With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. Age ≥18 years, any gender.\n2. Pathologically confirmed DLBCL (not otherwise specified) according to the revised 2017 WHO classification of lymphoid neoplasms, with non-germinal center B-cell-like (non-GCB) subtype confirmed by Han's algorithm (Appendix 1), based on previous pathological records or confirmed during screening. Must be able to provide sufficient tumor tissue or slides (from previous or screening biopsies) for central laboratory confirmation of pathological diagnosis (if the local pathology report is clear, patients may be enrolled and start treatment without waiting for the central pathology report).\n3. Patients who are refractory or have relapsed after at least two prior lines of therapy (at least one line must include an anti-CD20 antibody-containing regimen) (see section 6.3 for definition of refractory or relapsed).\n4. At least one measurable lesion (nodal lesion with longest diameter \\>1.5 cm, extranodal lesion with longest diameter \\>1.0 cm).\n5. Not planned for autologous stem cell transplantation (ASCT).\n6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n\nExclusion Criteria:\n\n1. Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission).\n2. DLBCL resulting from histological transformation of an previously diagnosed indolent lymphoma \\[such as follicular lymphoma (FL), marginal zone lymphoma, chronic lymphocytic leukemia, etc.\\] or pathological findings suggesting concomitant FL (any grade).\n3. Diagnosis of other types of large B-cell lymphoma or special types of DLBCL, including but not limited to high-grade B-cell lymphoma, EBV-positive DLBCL, T-cell\u002Fhistiocyte-rich large B-cell lymphoma, primary mediastinal large B-cell lymphoma, etc.\n4. Previous exposure to Lobertinib or known allergy to any excipient of Lobertinib (including microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fumaric acid, and gastric-soluble film coating premix); allergy or intolerance to Rituximab or any of its excipients; allergy or intolerance to both Bendamustine and Lenalidomide or any of their excipients.\n5. Previous refractoriness to BTK-targeting drugs.\n6. Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.",{"count":155,"type":20},150,[23],"This is an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR\u002FR2 regimen in patients with non-GCB DLBCL.",[57],"2025-12-14",{"date":161,"type":35},"2025-12-16",{"date":163,"type":35},"2025-11-27",{"date":165,"type":20},"2028-12-31",{"name":41,"class":42},41,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},"100438777","phase-1-a-study-of-lp-168-in-participants-with-relapse-or-refractory-b-cell-lymphoma-100438777","NCT04993690","A Study of LP-168 in Participants With Relapse or Refractory B-Cell Lymphoma","A Phase 1 Open-Label Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of LP-168 in Adult Patients With Relapse or Refractory B-Cell Lymphoma","Key Inclusion Criteria:\n\n* Per 2017 revised WHO lymphoma classification criteria, subject must have either:\n\nDiagnosed with relapsed or refractory DLBCL or FL and require treatment in the opinion of the Investigator and have received 2 lines SOC.\n\nDiagnosed with relapsed or refractory non-Hodgkin's lymphoma associated with B-cell proliferation (such as CLL\\\\ SLL \\\\ MCL \\\\ MZL \\\\ WM, etc.) in need of treatment in the opinion of the Investigator and have received 1 line SOC.\n\n* Adequate hematologic function.\n* Adequate hepatic and renal function.\n* Ability to receive study drug therapy orally and willing to receive examinations.\n* Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \\[and 2 years of non-therapy-induced amenorrhea\\] or surgically sterile) to observe conventional and effective birth control.\n\nKey Exclusion Criteria:\n\n* According to the 2017 revised WHO Lymphoma Classification Criteria, patients diagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma, lymphoblastic lymphoma\u002Fleukemia, and post-transplant lymphoproliferative disease(PTLD).\n* Prior malignancy (other than the disease under study) within the past 3 years, except for curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix or breast cancer.\n* Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of LP-168:\n\nAntitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and\u002For immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.\n\n* Subjects who have received the following treatments within 2 weeks before the first dose of LP-168:\n\nSteroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.\n\n* Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections; Disease affects the central nervous system with obvious symptoms; Autoimmune hemolytic anemia or Idiopathic thrombocytopenic purpura. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.\n* Subjects who cannot tolerate urine collection, venipuncture, lymph node biopsy, and bone marrow aspiration.","80 Years",{"count":177,"type":20},200,[53],"This is an open-label, multi-center Phase 1\u002F2 study of oral LP-168 in patients with CLL\u002FSLL and NHL who have failed or are intolerant to standard of care.",[181],"B-cell Lymphoma","2025-09-18",{"date":184,"type":35},"2025-09-23",{"date":186,"type":35},"2021-07-06",{"date":188,"type":20},"2027-06-30",{"name":41,"class":42},3,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":123},"100535388","phase-1-phase-ib-study-of-rocbrutinib-in-combination-with-r-chop-in-patients-with-newly-diagnosed-b-cell-non-hodgkin-lymphoma-100535388","NCT06251180","Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma","A Phase Ib Study to Assess Safety and Preliminary Efficacy of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-NHL","Inclusion Criteria:\n\n* Participants was histopathologically diagnosed with any of the following diseases: DLBCL, MZL or MCL (if enrolled in the dose expansion phase, histological confirmation of non-GCB subtype), and have not previously received anti-tumor systemic therapy or local radiation therapy for the above diseases.\n* Participants must have at least one measurable lesion.\n* ECOG physical status score 0-2.\n* Life expectancy ≥6 months.\n* International Prognostic Index (IPI) score ≥ 2 (only participants with DLBCL in dose expansion portion).\n* Adequate coagulation, liver, kidney, and hematopoietic functions：PT and APTT \\\u003C1.5x ULN; serum bilirubin \\\u003C1.5x ULN except in participants with Gilbert's syndrome who must have a serum bilirubin of \\\u003C3x ULN, AST and ALT ≤ 3x ULN or \\\u003C 5x ULN if hepatic involvement are present; serum creatinine (Scr) ≤1.5 x ULN, or calculated creatinine clearance ≥ 30ml\u002Fmin by Cockcroft-Gault formula.; ANC≥1500\u002Fmm3, hemoglobin≥8.0 g\u002FdL, and platelets \\>100,000\u002Fmm3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician.\n* Women of childbearing potential must have a negative serum or urine (beta-human chorionic gonadotropin \\[beta-hCG\\]) at screening.\n* Women of childbearing potential and men who are sexually active with a woman of childbearing potential must be practicing a highly effective contraceptive measures of during and after the study (90 days after the last dose of ROCBRUTINIB and 12 months after the last dose of Rituximab). Men must agree to not donate sperm during and for up to 90 days after he last dose of ROCBRUTINIB.\n* Participants voluntarily enrolled and signed the informed consent form, and followed the trial treatment and visits.\n\nExclusion Criteria:\n\n* Participants are allergic to Rocbrutinib or any of its excipients; Participants who are assessed by the investigator as being unable to tolerate the R-CHOP regimen.\n* Participants with known central nervous system involvement with lymphoma. or diagnosis of primary central nervous system lymphoma (PCNSL) or primary mediastinal large B-cell lymphoma (PMBL).\n* Participants with DLBCL had a history of indolent lymphoma such as FL or CLL (Richter's transformation), or was histopathologically comfirmed with FL (regardless of grade) coexistentially.\n* Prior treatment with solid organ transplantation or hematopoietic stem cell transplantation(HSCT) ; expected HSCT during the study.\n* Major surgery within 4 weeks of study entry or expected major surgery during the study.\n* Prior another non-antitumor or medical instruments clinical trials within 4 weeks.\n* Known bleeding diseases (such as von Willebrand's disease or hemophilia A, hemophilia B, etc.), or have bleeding tendency.\n* Prior treatment with warfarin or equivalent vitamin K antagonists within 14 days; requires anticoagulation with warfarin or equivalent vitamin K antagonists.\n* Prior treatment with strong\u002Fmoderate CYP3A4 inhibitors within 5 days or prior foods with inhibitory effects on CYP3A4 within 3 days at screening; requires chronic treatment with moderate\u002Fstrong CYP3A inhibitors or inducers, or OATP1B1\u002FOATP1B3 sensitive substrates during the study.\n* Participants with other malignancies other than the target indications of this study within the past three years.\n* Prior treatment with the cumulative dose of doxorubicin ≥150 mg\u002Fm2 (or other anthracyclines at doses converted based on cumulative cardiac toxicity)\n* Any serious medical condition including but not limited to uncontrolled hypertension, uncontrolled congestive heart failure or ≥Class 2 cardiac disease as defined by the New York Heart Association Functional Classification or LVEF less than 40%, uncontrolled or symptomatic arrhythmias with corrected QT interval (QTc) \\> 480 msec, uncontrolled diabetes mellitus, active\u002Fsymptomatic coronary artery disease, COPD, renal failure, severe hepatic disease, uncontrolled active infection, active hemorrhage.\n* Known HIV infection, or syphilis infection, or hepatitis B DNA or hepatitis C RNA positive.\n* Known diseases that affect drug swallowing or absorption.\n* Unfit to participate in this study in the investigator's opinion.","70 Years",{"count":200,"type":20},112,[53],"This is an open-label, multicentre Phase Ib study to evaluate the safety and preliminary efficacy of new generation Bruton Tyrosine Kinase inhibitor Rocbrutinib in combination to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) in adult patients with newly diagnosed, previously untreated B-cell Non-Hodgkin Lymphoma \\[Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)\\].",[204],"B-cell Non-Hodgkin Lymphoma","2025-03-21",{"date":207,"type":35},"2025-03-25",{"date":209,"type":35},"2024-04-10",{"date":211,"type":20},"2029-12-31",{"name":41,"class":42},""]