[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sll-small-lymphocytic-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sll-small-lymphocytic-lymphoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,78,100],{"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","2026-05-12",{"date":68,"type":69},"2026-05-14","ACTUAL",{"date":71,"type":69},"2026-04-23",{"date":73,"type":20},"2030-07-30",{"name":75,"class":76},"Newave Pharmaceutical Inc","INDUSTRY",4,{"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":65,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":77},"100570565","phase-1-a-phase-1-study-of-ze50-0134-in-relapsed-and-refractory-chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma-and-select-low-grad-lymphomas-100570565","NCT06708897","A Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Select Low-grad Lymphomas","Phase 1 Study of 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.\n2. Disease as defined below:\n\n   Part 1: Patients with symptomatic CLL or SLL (defined by iwCLL) without del(17p)\u002FTP53 must have received ≥2 prior therapies that have included a BTKi and venetoclax (or declined this) or Patients with progressive low-grade lymphoma that includes marginal zone lymphoma, lymphoplasmacytic lymphoma (including Waldenstrom's macroglobulinemia) who have received at least 2 therapies including a BTKi and CD20 antibody-based therapy.\n\n   Part 2: Patients with symptomatic CLL or SLL (defined by iwCLL) must have received ≥1 prior therapies that have included a BTKi and be venetoclax naive.\n3. Prior to beginning part 2, an activation amendment will be submitted to the FDA that includes safety, pharmacokinetics, pharmacodynamics and early efficacy data from the Part 1 portion. At this time, we may also include cohorts of specific types of low-grade lymphoma as well. Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 7 days before the first dose of study drug:\n\n   * Absolute neutrophil count (ANC) \\> 0.75 x 109\u002FL. For subjects with documented bone marrow involvement ≥ 0.5 x 109\u002FL\n   * Platelet count \\> 50 x 109\u002FL. For subjects with documented bone marrow involvement ≥ 30 x 109\u002FL\n   * Serum aspartate transaminase (AST\u002FSGOT) or alanine transaminase (ALT\u002FSGPT) ≤ 3.0 x upper limit of normal (ULN)\n   * Total bilirubin ≤ 1.5 x ULN\n   * Creatinine or Cystatin C glomerular filtration rate (GFR) ≥60 mL\u002Fmin. Estimated GFR (eGFR) according to the Modification of Diet in Renal Disease Study Group (MDRD) formula and expressed in mL\u002Fmin. To convert mL\u002Fmin\u002F1.73 m2 to mL\u002Fmin multiply by the individual's BSA calculated using an appropriate formula and divide by 1.73 Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less Negative serum or urine pregnancy test must be obtained within 7 days before the first dose of study drug in women of childbearing potential. Negative results must also be available before each cycle.\n\nPostmenopausal women, as defined below, are exempt from pregnancy testing:\n\n* Age \\>50 years with amenorrhea for at least 12 months or\n* Age ≤50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (\\>40 mIU\u002FmL) OR\n* Permanently sterilized women (e.g., hysterectomy, bilateral salpingectomy, or uterine ablation) Women and men of reproductive potential must agree to use highly effective contraception when sexually active. This applies for the period between signing of the informed consent and 90 days after the last administration of study drug. These methods should be documented in source documents. The investigator or a designated associate is requested to advise the subject on how to achieve highly effective birth control. Ability to understand and the willingness to sign a written informed consent. A signed informed consent (including consent for genetic biomarker\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they display any of the following criteria:\n\n1. FOR PART 2 ONLY\n\n   \\- No prior venetoclax treatment\n\n   FOR BOTH PARTS ALL THE FOLLOWING APPLY:\n2. Know active Richter's transformation. Patients who have been treated for this diagnosis and have been in remission for \\> 2 years without evidence of this and who have only CLL are considered eligible\n3. Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study.\n4. Clinically significant cardiac disease including congestive heart failure \\> New York Heart Association (NYHA) Class II, evidence for uncontrolled coronary artery disease (e.g., unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose, major regional wall motion abnormalities upon baseline echocardiography), and cardiac arrhythmias requiring anti- arrhythmic therapy except for beta-blockers and digoxin.\n5. Known Active cytomegalovirus (CMV), hepatitis B or C virus infection.\n6. Known Active SARS-CoV-2 infection; prior SARS-CoV-2 infection allowed if completely recovered \\> 14 days.\n7. Active clinically serious infections of Grade \\>2, requiring parenteral therapy; Subjects may be eligible after infection resolves.\n8. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days of enrolment.\n9. Allogeneic bone marrow transplant within 4 months before first dose of study drug (Subjects must have completed immunosuppressive therapy before enrollment).\n10. Active cancer that limits expected survival to \\\u003C 2 years or requires active therapy concomitant with this treatment. Exclusions would be localized skin cancer, breast cancer, prostate cancer that are resected or malignancies treated with hormonal or immune therapies alone. All cases of secondary cancer should be discussed with the medical monitor.\n11. A physical exam or laboratory finding that contraindicates the use of investigational therapy or otherwise places the subject at excessively high risk for treatment, as determined by the investigator. A discussion between the investigator and sponsor regarding eligibility is encouraged for such cases.\n12. Unresolved toxicity of previous treatments (excluding cases of alopecia) Grade ≥2.\n13. Requires ongoing immunosuppressive therapy, including systemic (e.g., intravenous or oral) corticosteroids for the treatment of cancer or other conditions. Note: Subjects may use topical or inhaled corticosteroids or low-dose steroids (≤10 mg of prednisone or equivalent per day) as therapy for comorbid conditions. Short courses of steroids before first dose are allowed for tumor flare.\n14. Major surgery or significant trauma within 4 weeks before the first dose of study drug.\n15. Breastfeeding women: breastfeeding women have to discontinue breastfeeding before onset of and during treatment and should be discontinued for at least 3 months after end of treatment.\n16. Subjects with QTcF \\> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications.",{"count":86,"type":20},66,[88],"PHASE1","This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and select low-grad lymphomas.",[26,27,30],"2025-11-28",{"date":93,"type":69},"2025-12-05",{"date":95,"type":69},"2025-04-08",{"date":97,"type":20},"2028-04",{"name":99,"class":76},"Lomond Therapeutics Holdings, Inc.",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100591334","phase-1-a-phase-ib-study-of-the-selective-pkc--inhibitor-ms-553-in-patients-with-refractory-or-relapsed-cllsll-100591334","NCT06979076","A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed CLL\u002FSLL","A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Diagnosis of CLL or SLL:\n\n   1. History of histologically documented CLL or SLL that meets iwCLL diagnostic criteria according to the 2018 guidelines, and\n   2. Indication for treatment as defined by the 2018 iwCLL guidelines, or the need for disease reduction prior to allogeneic transplantation.-\n\nExclusion Criteria:\n\n1. Current transformation of CLL\u002FSLL non-Hodgkin lymphoma or Hodgkin lymphoma.\n2. Active and uncontrolled autoimmune cytopenia(s).",{"count":108,"type":20},12,[88,110],"PHASE2","A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma",[27,30],"NOT_YET_RECRUITING","2025-09-23",{"date":116,"type":69},"2025-09-29",{"date":118,"type":20},"2026-07",{"date":120,"type":20},"2028-12",{"name":122,"class":76},"MingSight Pharmaceuticals, Inc"]