[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cllsll\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cllsll":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,70,103,122,145,167,189,211,235,256],{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100524119","phase-3-global-trial-in-apg2575-for-patients-with-cllsll-100524119",false,"NCT06104566","Global Trial in APG2575 for Patients With CLL\u002FSLL","A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (GLORA Study)","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients that have documented CLL\u002FSLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months\n3. ECOG Performance Status grade 0-2\n4. Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:\n\n   * Absolute neutrophil count ≥ 1.0 × 109\u002FL\n   * Platelet counts ≥ 75 × 109\u002FL; in cases of thrombocytopenia\n   * Total hemoglobin ≥ 9 g\u002FdL,\n5. Adequate renal function\n\n   * Creatinine clearance must be \\> 50 ml\u002Fmin directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)\u002F(72 x creatinine), for women x 0.85) or an equally accurate method.\n   * For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml\u002Fmin may be eligible if a repeat estimate after adequate hydration is \\> 50 ml\u002Fmin.\n6. Adequate liver function as indicated by:\n\n   * Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome\n   * Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value\n   * Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value,\n   * International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN.\n7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements","ALL","18 Years","99 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL\u002FSLL patients who previously treated with BTK inhibitors",[27],"CLL\u002FSLL","RECRUITING","2026-06-16",{"date":31,"type":32},"2026-06-18","ACTUAL",{"date":34,"type":32},"2023-12-20",{"date":36,"type":21},"2027-10-31",{"name":38,"class":39},"Ascentage Pharma Group Inc.","INDUSTRY",135,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100422047","phase-1-study-of-oral-administration-of-lp-168-in-patients-with-relapsed-or-refractory-b-cell-malignancies-100422047","NCT04775745","Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.","A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.","Inclusion Criteria:\n\nA subject will be eligible for study participation if he\u002Fshe meets the following criteria:\n\n* Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies.\n* Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.\n* Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:\n\n  * Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN\n  * Calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin using 24-hour CrCl OR Cockcroft-Gault formula.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).\n* Subjects must have adequate bone marrow independent of growth factor support per local laboratory reference range at screening as follows:\n\n  * Absolute Neutrophil Count (ANC) ≥1000\u002FuL;\n  * An exception is for subjects with an ANC\\\u003C1000\u002FuL and bone marrow heavily infiltrated with underlying disease (approximately 60% or more) may use growth factor to achieve the ANC eligibility criteria per discussion between the Investigator and the Medical Monitor.\n  * Platelet count ≥ 50,000\u002FµL - OR - Platelet count ≥ 20,000\u002F µL if thrombocytopenia is clearly due to CLL disease under study (per Investigator discretion)\n  * Hemoglobin ≥8.0g\u002FdL, and can be achieved by transfusion\n\nExclusion Criteria:\n\nA subject will not be eligible for study participation if he\u002Fshe meets any of the following criteria.\n\n* Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)\u002Ftoxicity(s) of the previous therapy (other than alopecia):\n\n  * Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc;\n  * Any investigational therapy, including targeted small molecule agents.\n  * For CLL subjects who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) treatment, allow washout for 2 days as these subjects progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).\n* Subjects who require immediate cytoreduction. However, subjects may receive up to two days of steroids for symptoms of impending organ impairment and remain eligible.\n* Subject has received the following medications or therapies within 7 days prior to the first dose of study drug:\n\n  * Steroid therapy (at dosages equivalent to prednisone \\>20 mg\u002Fday) for anti-neoplastic intent (except as noted in exclusion criteria #3);\n  * Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers\u002Finhibitors.\n  * Potent CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.\n* Subjects require treatment with systemic acid-reducing agents including H-2-receptor antagonists and proton pump inhibitors with the following exceptions:\n\n  * Proton pump inhibitors should be discontinued at least 7 days prior and held throughout the study\n  * If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken again until 2-3 hours after the next dose of LP-168.\n  * If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and\u002For 2 or more hours after the dose of LP-168.\n* Subject has significant screening electrocardiogram (ECG) abnormalities including. 2nd degree AV block type II 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTc) ≥ 480ms.\n* Serum amylase \\> 1.5 × ULN or serum lipase \\> 1.5 × ULN.\n* Subject has any history of Richter's transformation for Phase 1a portion of the trial.\n* Subjects who have undergone autologous\u002Fallogeneic hematopoietic stem cell transplantation (HSCT) therapy within 90 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Patients in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and\u002For up to 20 mg\u002Fday prednisone or equivalent systemic steroids for ongoing GVHD is permitted.\n* Subject has a history of other active malignancies other than B-cell malignancies within the past 3 years prior to study entry, with the exception of:\n\n  * Adequately treated in situ carcinoma of the cervix uteri;\n  * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n  * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n* Subject requires anticoagulation with Warfarin.",{"count":49,"type":21},60,[51],"PHASE1","This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.",[27,54,55,56,57,58,59],"Waldenstrom Macroglobulinemia","Follicular Lymphoma","Diffuse Large B Cell Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Hairy Cell Leukemia","2026-02-10",{"date":62,"type":32},"2026-02-13",{"date":64,"type":32},"2021-07-19",{"date":66,"type":21},"2027-12-31",{"name":68,"class":39},"Newave Pharmaceutical Inc",4,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"100601323","phase-2-study-of-epcoritamab-as-a-consolidation-therapy-in-cllsll-100601323","NCT07108998","Study of Epcoritamab as a Consolidation Therapy in CLL\u002FSLL","A Phase 2 Study of Epcoritamab as a Consolidation Therapy for 2nd Generation BTKi +\u002F- Obinutuzumab in CLL\u002FSLL Patients or Variants of This.","Inclusion Criteria\n\n1. Diagnosis of CLL or SLL meeting the established 2018 iwCLL diagnostic criteria or variant of CLL\u002FSLL and has received a 2nd generation BTKi (acalabrutinib or zanubrutinib) +\u002F- obinutuzumab for a minimum of 12 months as first line therapy.\n\n   a) Note: Variation in flow cytometry is defined as patients who have atypical immunophenotyping for CLL (CD5 negative, CD23 negative or surface expression of CD79b that is bright ) but clinically behave like CLL (leukocytosis, lymphadenopathy and splenomegaly) and have the FISH\u002FCytogenetics translocations(del 13q, trisomy 12, Del11q) or genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL.\n2. Attainment of Partial Response or greater with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +\u002F- obinutuzumab but detectable disease in blood or bone marrow by NGS ClonoSEQ.\n3. Age ≥18 years.\n4. ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix D).\n5. Patients must have adequate organ and marrow function as defined below:\n\n   Absolute neutrophil count ≥1,000\u002FmcL, unless if neutropenia is due to underlying CLL bone marrow disease.\n\n   Hemoglobin ≥8 g\u002Fdl unless if related to underlying CLL Platelets ≥50,000\u002F µL unless if related to underlying CLL Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (excepting Gilbert's syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the UC PI).\n\n   AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN Glomerular filtration rate (GFR) Calculated GFR using CKD-EPI formula ≥ 30 (See Appendix E) or multiplying the estimate of GFR by an individual body surface area calculated using an appropriate formula and dividing by 1.73 m2.\n6. Women of childbearing potential and non-sterile males must practice at least 1 of the following methods of birth control with their partner(s) throughout the study and for 4 months after discontinuing study drug:\n\n   1. Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable.\n   2. Surgically sterile partner(s) by vasectomy, bilateral orchiectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.\n   3. Intrauterine device.\n   4. Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 1-month prior to study drug administration.\n7. Women of childbearing potential must have a negative pregnancy result as follows: At Screening on a serum sample obtained within 7 days prior to the first study drug administration. If a urine pregnancy test at any timepoint during the study is positive or indeterminate, a serum pregnancy test will be performed for confirmation.\n8. Non-sterile males must refrain from sperm donation, from initial study drug administration until 4 months after the last dose of study drug.\n9. Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n1. Obtaining a CR or nodal PR with no detectable disease in blood or bone marrow after treatment with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +\u002F- obinutuzumab as assessed by Adaptive's NGS ClonoSEQ.\n2. Absence of CD20 expression on CLL cells at pre-treatment.\n3. Received any prior treatment ever with a CD3×CD20 bispecific antibody.\n4. Organ transplant recipients are excluded except those with no active graft versus host disease (GVHD) requiring treatment within 12 months of beginning treatment on study.\n5. Receipt of a live vaccine within 28 days prior to study treatment initiation.\n6. Autoimmune diseases requiring high dose immunosuppressives (e.g., above 20 mg prednisone daily).\n7. Central nervous system (CNS) disease(s) unless in the opinion of the investigator these would not preclude the patient from participation.\n8. Known hypersensitivity to any of the components of the treatment drugs (see Investigators Brochure for a list of components).\n9. Patients with active Richter's transformation.\n\n   a. Note: the following will be eligible and not excluded: patients with accelerated phase or prolymphocytic progression\n10. Patients who have received prior radiation therapy (RT) unless in the opinion of the investigator the prior receipt of RT will not adversely impact the patient's ability to participate.\n11. Patients who require anti-coagulation with warfarin or equivalent Vitamin K antagonist.\n12. Major surgery within 14 days prior to the first dose of study drug.\n13. Patient has significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 180 days prior to the first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or left ventricular ejection fraction ≤ 40%.\n14. Pregnant women, those planning to become pregnant during the study, and\u002For breastfeeding women are ineligible for participation.\n15. Patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    1. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). No new IV therapy or intravenous antibiotics may be initiated within 2 weeks prior to first dose of study drug.\n    2. Known poorly controlled human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HBsAg positive, or HBcAb positive with detectable HBV DNA load; active hepatitis C defined as HCV antibody positive with HCV RNA positive)\n    3. Unexplained fever \\> 38.3°C within 7 days prior to the first dose of study drug administration (if the fever is considered attributed to the patient's malignancy or an explained infection, the Patient may be enrolled at the discretion of the Investigator).\n16. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the Investigator.",{"count":78,"type":21},22,[80],"PHASE2","This is a phase 2 study of Epcoritamab as a consolidation therapy for 2nd generation BTKi +\u002F- Obinutuzumab in CLL\u002FSLL patients or patients with variants of this.",[27,83,84,85,86,87,88],"CLL","SLL","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Small Lymphocytic Lymphoma Variant","Chronic Lymphocytic Leukemia Variants",[90,91],"Epcoritamab","Obinutuzumab","2026-01-02",{"date":94,"type":32},"2026-01-06",{"date":96,"type":32},"2025-08-22",{"date":98,"type":21},"2029-07-01",{"name":100,"class":101},"Zulfa Omer","OTHER",1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100402681","phase-2-retreatment-with-venetoclax-and-acalabrutinib-after-venetoclax-limited-duration-reveal-100402681","NCT04523428","REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)","A Prospective, Multicenter, Phase-II Trial of Venetoclax Plus Acalabrutinib in Patients Who Have Relapsed After First Line Venetoclax + Anti-CD20 mAb Treatment for Chronic Lymphocytic Leukemia (CLL or SLL)","Inclusion Criteria:\n\n* Documented CLL or SLL requiring treatment according to IWCLL criteria (appendix A) after at least (clinical) partial response as best response after the following initial study treatment: venetoclax-rituximab in HOVON 140\u002FGAIA or venetoclax-obinutuzumab in HOVON 139\u002FGIVE or HOVON 140\u002FGAIA;\n* WHO\u002FECOG performance status 0-3 (appendix C), stage 3 only if attributable to CLL\n* Age at least 18 years;\n* Adequate BM function defined as:\n\n  * Hemoglobin \\>5 mmol\u002Fl or Hb \\> 8 g\u002FdL\n  * Absolute neutrophil count (ANC) \\>0.75 x 109\u002FL (750\u002FμL), unless directly attributable to CLL infiltration of the BM, proven by BM biopsy\n  * Platelet count \\>30 x 109\u002FL (30,000\u002FμL) without transfusion and irrespective whether it is attributable to CLL infiltration in the BM;\n* Estimated Glomerular Filtration Rate (eGFR) (MDRD) or estimated creatinine clearance (CrCl ≥ 30ml\u002Fmin (Cockcroft-Gault appendix E); Please note: in case eGFR or CrCl is \\\u003C50ml\u002Fmin the patient needs to be considered high risk for TLS\n* Adequate liver function as indicated:\n\n  * Serum aspartate transaminase (ASAT) and alanine transaminase (ALAT) ≤ 3.0 x upper limit of normal (ULN);\n  * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin);\n* Prothrombin time (PT)\u002FInternational normal ratio (INR) \\\u003C1.5 x ULN and activated partial thromboplastin time (aPTT) \\\u003C1.5 x ULN;\n* Negative serological testing for hepatitis B virus (HBV) (Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) negative) and hepatitis C virus (hepatitis C antibody). Subjects who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative PCR within 6 weeks before enrollment. Those who are PCR positive will be excluded; Please note: For patients positive for anti-HBc HBV-DNA PCR has to be repeated every month until 12 months after last dose of study treatment.\n* Patient is able and willing to adhere to the study visit schedule and other protocol requirements;\n* Patient is capable of giving informed consent;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Any prior therapy with BTK inhibitor;\n* Prior treatment with venetoclax other than first line;\n* Other therapy with exception of chemo-\u002Fimmunotherapy which is allowed also after venetoclax first line relapse;\n* Transformation of CLL (Richter's transformation);\n* Patient with a history of confirmed progressive multifocal leukoencephalopathy (PML);\n* Malignancies other than CLL currently requiring systemic therapy or not treated in curative intention or showing signs of progression after curative treatment;\n* Known allergy to xanthine oxidase inhibitors and\u002For rasburicase;\n* History of drug-specific hypersensitivity or anaphylaxis to any study drug (including active product or excipient components);\n* Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease);\n* Active fungal, bacterial, and\u002For viral infection that requires systemic therapy; Please note: active controlled as well as chronic\u002Frecurrent infections are at risk of reactivation\u002Finfection during treatment;\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled: infection, auto-immune hemolysis, immune thrombocytopenia, diabetes, hypertension, hyperthyroidism or hypothyroidism etc.);\n* Patient known to be HIV-positive;\n* Patient requiring treatment with a strong cytochrome P450 (CYP) 3A inhibitor\u002Finducer (see appendix J) or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists; Please note: Patients being treated with DOACs apixaban, edoxaban or rivaroxaban can be included, but must be properly informed about the potential risk of bleeding under treatment with acalabrutinib. (see appendix J)\n* History of stroke or intracranial hemorrhage within 6 months prior to registration;\n* Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease, myocardial infarction within 6 months) (CTCAE grade III-IV, see appendix D);\n* Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);\n* Severe neurological or psychiatric disease (CTCAE grade III-IV, see appendix D);\n* Patient who has difficulty with or are unable to swallow oral medication, or have significant gastrointestinal disease that would limit absorption of oral medication;\n* Vaccination with live vaccines within 28 days prior to registration;\n* Use of any other experimental drug or therapy within 28 days of registration;\n* Major surgery within 28 days prior to registration;\n* Steroid therapy within 10 days prior to registration, with the exception of inhaled steroids for asthma, topical steroids, steroids up to 20 mg or dose equivalents of prednisolone daily to control autoimmune phenomenon's, or replacement\u002Fstress corticosteroids;\n* Pregnant women and nursing mothers;\n* Fertile men or women of childbearing potential unless: (1) surgically sterile or ≥ 2 years after the onset of menopause; (2) willing to use a highly effective contraceptive method such as oral contraceptives, intrauterine device, sexual abstinence or combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) during study treatment and for 30 days after end of treatment;\n* Current participation in other clinical trial (other than follow up HOVON139\u002FHOVON140);\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":49,"type":21},[80],"Fixed-duration regimens containing combinations of venetoclax with CD20 targeting agents are expected to soon become standard practice in first-line patients with chronic lymfocytic leukemia (CLL). The advantage of a fixed duration venetoclax combination as part of first-line treatment is the potential to retreat with venetoclax in patients who develop relapsed disease after a treatment free period. However, efficacy of venetoclax retreatment following a fixed duration venetoclax combination is still hypothetical as clinical data are lacking. Thus, there is an urgent need for data proving efficacy of venetoclax combinations following venetoclax treatment cessation. Testing of a novel venetoclax-containing regimen for relapsed CLL without the repeat of anti-CD20 monoclonal antibody (mAb) is a rational approach.",[27],{"date":94,"type":32},{"date":116,"type":32},"2020-12-23",{"date":118,"type":21},"2032-12",{"name":120,"class":101},"Stichting Hemato-Oncologie voor Volwassenen Nederland",18,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":102},"100591258","phase-2-lp-168-and-obinutuzumab-for-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-and-variants-of-this-100591258","NCT06978088","LP-168 and Obinutuzumab for Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) and Variants of This","A Multicenter Parallel 2 Cohort Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated, and T474 Gatekeeper Mutant Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) and Variants of This","Inclusion Criteria:\n\n1. Diagnosis of CLL or SLL meeting criteria established in the 2018 iwCLL criteria and requiring treatment. Patients with variation in flow cytometry findings will be allowed to enroll if cytogenetics and\u002For mutational studies are supportive of CLL\u002FSLL variant.\n\n   a) Note: Variation in flow cytometry is defined as patients who have atypical immunophenotyping for CLL (CD5 negative, CD23 negative or surface expression of CD79b that is bright ) but clinically behave like CLL (leukocytosis, lymphadenopathy and splenomegaly) and have the FISH\u002FCytogenetics translocations(del 13q, trisomy 12, Del11q) or genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL.\n2. Meet the criteria for inclusion into at least one of the following 2 cohorts:\n\n   1. Cohort 1: One or more prior therapies for CLL\u002FSLL including BCL2 inhibitor (BCL2i), and\u002For chemotherapy and\u002For BTK inhibitor (BTKi).\n\n      • Note: Patients can be eligible if their CLL\u002FSLL has been non-responsive to a covalent and noncovalent BTKi. Patients intolerant to BTKi whose disease becomes resistant to a second one are eligible to enroll. Prior treatment with CD20 will not be exclusionary.\n   2. Cohort 2: Treatment with a prior BTKi (covalent and noncovalent) and have a BTK gatekeeper mutation in the T474 coordinate.\n3. Age ≥18 years.\n4. ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix A).\n5. Patients must have adequate organ and marrow function as defined below:\n\n   1. ANC ≥1,000\u002FmcL, unless if neutropenia is due to underlying CLL bone marrow disease.\n   2. Platelets ≥ 50,000\u002F µL unless if thrombocytopenia is due to underlying CLL bone marrow disease then platelets of ≥20,000 is acceptable\n   3. Total bilirubin ≤1.5 x ULN (excepting Gilbert's syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the UC PI).\n   4. AST and ALT ≤2.5 × ULN.\n   5. Estimated glomerular filtration rate (by Modification of Diet in Renal Disease \\[MDRD\\]) or Chronic Kidney Disease Epidemiology \\[CKD-EPI\\]) ≥ 30 mL\u002Fmin\n6. Women of childbearing potential and non-sterile males must practice at least 1 of the following methods of birth control with their partner(s) throughout the study and for 30 days after discontinuing study drug:\n\n   1. Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable.\n   2. Surgically sterile partner(s) by vasectomy, bilateral orchiectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.\n   3. Intrauterine device.\n   4. Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 1-month prior to study drug administration.\n7. Women of childbearing potential must have a negative pregnancy result as follows: At Screening on a serum sample obtained within 7 days prior to the first study drug administration. If a urine pregnancy test at any timepoint during the study is positive or indeterminate, a serum pregnancy test will be performed for confirmation.\n8. Non-sterile males must refrain from sperm donation, from initial study drug administration until 30 days after the last dose of study drug.\n9. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Patients with active Richter's transformation.\n2. Patient has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)\u002Ftoxicity(s) of the previous therapy (other than alopecia):\n\n   1. Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc.\n   2. Any investigational therapy, including targeted small molecule agents.\n   3. For patients who come off BCR antagonist treatment (BTK inhibitors, PI3K inhibitors, etc.), allow washout for 5 half-lives as these patients progress quickly after treatment discontinuation and then remain eligible (steroids may be given during the washout to allow for disease control, see d below for details).\n   4. When a patient's intercurrent health condition would require short term steroid use this should be discussed with the Investigator in consultation with the Medical Monitor. Steroids are allowed for disease control in those R\u002FR patients when use is limited to 2-3 days to allow for control of the underlying disease. Steroids may be given during the washout to allow for disease control.\n3. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous, in the opinion of the Investigator.\n4. Patients who require anti-coagulation with warfarin or equivalent Vitamin K antagonist.\n5. Major surgery within 14 days prior to the first dose of study drug.\n6. Patients who have received the following medications or therapies within 5 half-lives or 14 days, whichever is shorter, prior to the first dose of study drug:\n\n   1. Steroid therapy (at dosages equivalent to prednisone \\>20 mg\u002Fday) for anti- neoplastic intent (except as noted in exclusion criterion #2).\n   2. Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers\u002Finhibitors (see the list in Appendix B)\n   3. Strong CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort (Appendix B)\n   4. There is a 28-day washout period required for patients who have had prior CAR T treatment if there is no evidence of cytokine release syndrome (CRS) or other AEs related to the CAR T treatment per discussion with the UC PI; reduced washout period may be acceptable after discussion with UC PI.\n   5. Drugs that are substrates of MATE1 and MATE2-K should be avoided or substituted for other medications if possible. Use of these (if done) must be discussed with the PI of the study. (Appendix D).\n7. Patient has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or Star fruit within 3 days prior to the first dose of study drug.\n8. Patient requires treatment with systemic acid-reducing agents, H2 blocking agent and proton pump inhibitors, with the following exceptions:\n\n   1. Proton pump inhibitors should be discontinued at least 7 days or at least 5-half-lives (whichever is shorter) prior and held throughout the study.\n   2. If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken again until 2 - 3 hours after the next dose of LP-168.\n   3. If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and\u002For 2 or more hours after the dose of LP-168.\n9. Patient has clinically significant screening electrocardiogram (ECG) abnormalities including:\n\n   1. 2nd degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTcF) ≥ 480ms (calculated per Fridericia's formula \\[QTcF = QT\u002FRR (1\u002F3)\\]).\n   2. For patients with presence of right bundle branch block (RBBB) or left bundle branch block (LBBB), cardiology review is needed to correct QTcF calculation using Sponsor recommended formula (Simplified Formula for Bundle Branch Block). See Appendix C.\n   3. Other clinically significant ECG abnormalities per PI discretion.\n10. Patient has significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 180 days prior to the first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or left ventricular ejection fraction ≤ 40%.\n11. Patient has a history of stroke or intracranial hemorrhage within 180 days prior to the first dose of study drug.\n12. Patients who have undergone autologous\u002Fallogeneic hematopoietic stem cell transplantation (HSCT) therapy within 60 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (patients in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks). The use of topical steroids and\u002For up to 20 mg\u002Fday prednisone or equivalent systemic steroids for ongoing GVHD is permitted.\n13. Pregnant women, those planning to become pregnant during the study, and\u002For breastfeeding women are ineligible for participation.\n14. Patients with known malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.\n15. Known hypersensitivity to any of the components of LP-168 (see Investigators Brochure for a list of components).\n16. Patients with active bleeding disorder.\n\n    a) NOTE: Von Willebrand's disease or hemophilia will not be excluded if patient is on treatment and well controlled.\n17. Patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    1. Uncontrolled active systemic infection (bacterial, fungal, viral);\n    2. Known poorly controlled (defined as less than 200 CD4 count) human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HBsAg positive, or HBcAb positive with detectable HBV DNA load; active hepatitis C defined as HCV antibody positive with HCV RNA positive)\n    3. Unexplained fever \\> 38.3°C within 7 days prior to the first dose of study drug administration (if the fever is considered attributed to the patient's malignancy or an explained infection, the Patient may be enrolled at the discretion of the Investigator).\n18. Patient has a history of other active malignancies within the past 1 year prior to study entry, with the exception of:\n\n    1. Breast cancer or prostate cancer on endocrine therapy with stable disease.\n    2. Continuation of maintenance therapy in patients with adequately treated malignancy.\n    3. Cancer with expected survival of 2 years or more or that will not confound evaluation of LP-168 treatment.\n    4. Adequately treated in situ carcinoma of the cervix uteri.\n    5. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin.\n    6. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n    7. Patients with active CNS involvement can be enrolled per Investigator discretion; patients with significant clinical symptoms, including any that require treatment with high dose steroid, will be excluded.",{"count":130,"type":21},34,[80],"Multicenter Parallel 2 Cohort Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated, and T474 Gatekeeper Mutant Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) and Variants of This.",[134,86,27,85],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma",[136,91,85,86],"LP-168","2025-08-11",{"date":139,"type":32},"2025-08-14",{"date":141,"type":32},"2025-06-01",{"date":143,"type":21},"2034-06-01",{"name":100,"class":101},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},"100379072","phase-1-study-of-apg-2575-as-a-single-agent-or-in-combination-with-other-therapeutic-agents-for-cllsll-100379072","NCT04215809","Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL\u002FSLL","APG-2575CU101, A Phase Ib Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents in Patients With Relapsed and\u002For Refractory Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","Inclusion Criteria:\n\n1. ≥18 years of age.\n2. Histologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) according to the 2018 international workshop (IW) CLL criteria who must have relapsed or be refractory to at least one prior therapy for CLL\u002FSLL and require treatment by 2018 IWCLL criteria. In addition, lisaftoclax (600 mg) plus acalabrutinib combination cohort may include patients who are: (1) treatment-naïve, or (2) refractory to venetoclax.\n3. Eastern Cooperative Oncology Group (ECOG) ≤ 2.\n4. Patient must have objectively documented evidence of disease progression prior to study entry such as: escalating lymphocytes count with an increase \\> 50% over a period of two months or doubling time in less than 6 months; enlarging adenopathy or splenomegaly; increasing cytopenias; clinical B symptoms -night sweats, fatigue, \\> 1% weight loss in 6 months, fevers \\> 100.50F for ≥ one month without infection.\n5. Adequate bone marrow function independent of growth factor:\n\n   1. Absolute neutrophil count (ANC) ≥1.0× 109\u002FL in patient without bone marrow involvement. This criterion does not apply to patients with bone marrow involvement by CLL\u002FSLL.\n   2. Platelets count ≥30 x 109\u002FL (entry platelet count must be independent of transfusion within 7 days of first dose of lisaftoclax).\n6. Adequate renal and hepatic function as indicated by:\n\n   1. Serum creatinine ≤1.5×upper limit of normal (ULN); if serum creatinine is \\>1.5×ULN, creatinine clearance must be ≥ 50 mL\u002Fmin, calculated using the Cockcroft and Gault formula(140-Age)x mas (kg)\u002F(72x creatinine mg\u002FdL); multiply by 0.85 if female (Cockcroft 1976).\n   2. Total bilirubin ≤1.5 x ULN, except patients with known Gilbert's syndrome.\n   3. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C2.5 x ULN, Alkaline phosphatase\\\u003C2.5×ULN.\n   4. International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤1.5×ULN unless the patient is receiving anticoagulant therapy as long as PT or APTT is within therapeutic range of intended use of anticoagulants.\n7. Females of childbearing potential (i.e., not postmenopausal for at least 2 years or surgically sterile) must have negative results for pregnancy test performed:\n\n   1. At screening on a serum sample obtained within 14 days prior to the first lisaftoclax administration;\n   2. Prior to dosing on a urine sample obtained on the first day of lisaftoclax administration, if it has been \\>7 days since obtaining the serum pregnancy test results.\n8. Females of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing lisaftoclax:\n\n   1. Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable;\n   2. Surgically sterile partner(s); acceptable sterility surgeries are: vasectomy, bilateral tubal ligation, bilateral oophorectomy or hysterectomy\n   3. Intrauterine device (IUD);\n   4. Double-barrier method (contraceptive sponge, diaphragm or cervical cap with spermicidal fellies or cream AND a condom);\n   5. Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 3 months prior to lisaftoclax administration. If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to lisaftoclax administration.\n9. Male patients must refrain from sperm donation, from initial lisaftoclax administration until 90 days after the last dose of lisaftoclax.\n10. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).\n11. Willingness and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\n1. Patient has undergone allogeneic stem cell transplant \\\u003C 90 days.\n2. Patient has active graft-versus-host disease or require immunosuppressive therapy.\n3. Patient has undergone CAR-T cell therapy \\\u003C 30 days.\n4. Richter's Syndrome (patients with previously treated Richter's syndrome will be permitted if they are in remission).\n5. Prior anti-BCL-2 treatment (except patients who discontinued treatment for reasons other than disease progression and patients in the lisaftoclax plus acalabrutinib cohort).\n6. For the acalabrutinib and lisaftoclax combination cohort: (1) Patients who discontinued due to acalabrutinib toxicity (Note: Patients who received a BTK inhibitor therapy may participate whether, or not, they progressed following BTK inhibitor treatment). (2) Patients who require treatment with proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, etc.) at study entry. (Patients receiving proton pump inhibitors who switch to H2 receptor antagonists or antacids are eligible for enrollment to this study arm.) (3) Patients who require or are receiving anticoagulation therapy with warfarin or equivalent vitamin K antagonists within 7 days of first dose of the study drug(s).\n7. Active pathogen infections including human immunodeficiency virus syndrome (HIV) infection.\n8. Active hepatitis B infection, as defined seropositivity for Hep B surface antigen (HBsAg) or known active Hepatitis C infection as determined by Hepatitis C antibody with elevated liver enzymes as defined in the inclusion criteria or any other evidence of active Hepatitis C such as currently on treatment; or active COVID-19 infection. (Patients who have received COVID-19 vaccination will be considered as eligible for the study).\n9. Has known central nervous system (CNS) involvement.\n10. Prior malignancy that required treatment and has shown recurrence within 2 years of screening (except for non-melanoma skin cancer or adequately treated carcinoma in situ of cervix or breast). Cancer treated within 2 years with curative intent and without recurrence as well as prostate cancer on active surveillance are allowed.\n11. Concurrent treatment with any other investigational agent, received biologics (≤28 days), or small molecule targeted therapies (≤5 half-life) or other anti-cancer therapies (including chemotherapy) ≤14 days of first dose of lisaftoclax.\n12. Patient is pregnant or breast feeding.\n13. Has received the following within 7 days prior to the first dose of lisaftoclax:\n\n    1. Steroid therapy at a dose greater than prednisone 20 mg daily (or equivalent) for anti-neoplastic intent\n    2. CYP3A inhibitors such as fluconazole, ketoconazole, and clarithromycin\n    3. Potent CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.\n14. Radiation within 14 days of study entry.\n15. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ grade 1 or baseline, except alopecia or neuropathy.\n16. Failure to recover adequately, as judged by the Investigator, from prior surgical procedures. For example, patients with active wound healing; patients who have had major surgery within 28 days from 1st dose of lisaftoclax.\n17. Has a cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain.\n18. Unstable angina or myocardial infarction within 3 months of enrollment.\n19. QTc interval\\> 480ms (Bazett or Fredericia formulae) or other remarkable abnormal ECG findings, including second-degree type II atrioventricular block, third-degree atrioventricular block or bradycardia (ventricular rate of less than 50 beats per minute).\n20. Unable to swallow capsules or have gastrointestinal conditions that could affect the absorption of lisaftoclax in the opinion of the Investigator.\n21. Uncontrolled concurrent illness including, but not limited to: uncontrolled diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with the study requirements.\n22. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.","85 Years",{"count":154,"type":21},144,[51],"Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) \u002F recommended phase 2 dose (RP2D) of lisaftoclax.",[27],"2025-04-08",{"date":160,"type":32},"2025-04-10",{"date":162,"type":32},"2020-03-02",{"date":164,"type":21},"2027-06-30",{"name":38,"class":39},9,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":177,"phases":4,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":102},"100555176","current-status-of-btki-treatment-for-cllsll-in-china-100555176","NCT06508684","Current Status of BTKi Treatment for CLL\u002FSLL in China","Current Status and Influencing Factors of Chinese Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma Undergoing Treatment With Bruton's Tyrosine Kinase Inhibitors","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Patients with a confirmed diagnosis of CLL\u002FSLL;\n* Received BTK inhibitor treatment between February 2023 and February 2024.\n\nExclusion Criteria:\n\n* Patients with other types of lymphoma;\n* Cases deemed unsuitable for inclusion in this study by the investigators.","80 Years",{"count":176,"type":21},1000,"OBSERVATIONAL","BTKi has become the standard treatment regimen for CLL\u002FSLL，there is a lack of large-scale real-world studies on the use status and related influencing factors of BTK inhibitors. Therefore, we plan to conduct this multicenter retrospective cross-sectional study to understand the current situation of BTK inhibitor treatment for CLL\u002FSLL patients in China and the related influencing factors, and to explore more suitable treatment patterns based on this.",[27],"2024-07-14",{"date":182,"type":32},"2024-07-18",{"date":184,"type":32},"2024-07-13",{"date":186,"type":21},"2025-07-12",{"name":188,"class":101},"The First Affiliated Hospital with Nanjing Medical University",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100552731","phase-2-a-practical-clinical-study-comparing-the-fixed-cycle-regimen-containing-orelabrutinib-with-btki-monotherapy-100552731","NCT06476899","A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy","A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy in Previously Untreated CLL\u002FSLL","Inclusion Criteria:\n\n* Age between 18 and 70 years, with no gender restrictions;\n* Patients with CLL\u002FSLL who meet the iwCLL2018 diagnostic criteria;\n* Indications for treatment\n* ECOG performance score of 0-2;\n* Patients are untreated or have not received standardized treatment\n* Before the trial screening, the subject or their legal representative voluntarily signs a written informed consent form, indicating that they understand the purpose of the study and the necessary research steps, and are able to comply with the protocol and follow-up.\n\nExclusion Criteria:\n\n* Has been diagnosed or treated for malignancies other than CLL (including active central nervous system lymphoma) within the past year;\n* there is clinical evidence of Richter transformation;\n* Participant cannot receive or plan to receive another treatment during study participation\n* Other conditions that the investigator considers inappropriate for participation","70 Years",{"count":49,"type":21},[80],"Prospective, interventional, and practical clinical studies",[27],"NOT_YET_RECRUITING","2024-06-21",{"date":204,"type":32},"2024-06-27",{"date":206,"type":21},"2024-07-24",{"date":208,"type":21},"2026-12-26",{"name":210,"class":101},"Fei Li",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100540639","phase-3-a-global-study-of-lisaftoclax-apg-2575-combined-with-acalabrutinib-versus-immunochemotherapy-for-newly-diagnosed-cllsll-100540639","NCT06319456","A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL\u002FSLL.","A Global Multicenter, Open Label, Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib Versus Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (GLORA-2).","1. CLL\u002FSLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment.\n2. With a measurable disease.\n3. ECOG score 0-2.\n4. QTcF interval: ≤450ms in males, ≤470ms in females.\n5. Adequate bone marrow function independent of growth factor support.\n6. Adequate liver, kidney and coagulation function.\n7. Males and females of childbearing potential, and their partners voluntarily use effective contraceptive measures throughout the treatment and for at least three months after the last dose of the study drug. Male patients must avoid donation from the first dose of the study drug to three months after the last dose of the study drug.\n8. Female patients of childbearing potential have negative serum pregnancy test results within 14 days prior to the first dose of the study drug.\n9. Patients must be able to understand and voluntarily sign an informed consent form approved by the Ethics Committee (EC) before commencing any screening or study specific procedures.\n10. Must be willing and able to complete research procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1. Any previous CLL specific treatment.\n2. Failure to fully recover adequately from prior surgical procedures at the discretion of the investigator. Patients who receive a major surgery within 28 days prior to the first dose of the study drug or who receive a minor surgery (excluding biopsy) within 14 days prior to the initiation of the study.\n3. Presence of significant cardiovascular disease within 6 months prior to study entry.\n4. A history of significant kidney, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or liver disease, which will have an adverse effect on the patient if he\u002Fshe participates in the study, at the discretion of the investigator.\n5. Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.\n6. Known to have hypersensitivity to the drug ingredient or its analogues.\n7. Pregnant or lactating female patients and patients who are expected to become pregnant during the study period or within 3 months after the last dose.\n8. Patients who have history of other active malignant tumor other than CLL\u002FSLL within 3 years before study entry.\n9. With a malabsorption syndrome or other conditions unsuitable for enteral administration.\n10. Other clinically significant uncontrolled symptoms.\n11. With primary active autoimmune disease and connective tissue disease.\n12. Any other circumstances or conditions that would, at the discretion of the investigator, make the patient unsuitable for the study.",{"count":219,"type":21},344,[24],"This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL\u002FSLL.",[27],[27,224,225],"Lisaftoclax","APG-2575","2024-05-28",{"date":228,"type":32},"2024-05-29",{"date":230,"type":32},"2024-04-07",{"date":232,"type":21},"2028-08",{"name":38,"class":39},6,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100500065","phase-1-venetoclax-treatment-26-cycles-with-6-cycles-or-12-cycles-of-epcoritamab-in-patients-with-relapsed-or-refractory-cll-or-sll-100500065","NCT05791409","Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL","A Prospective Randomized Phase I\u002FII Trial of Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","AETHER","Inclusion Criteria:\n\n* Documented relapsed or refractory CLL or SLL (SLL in phase II part only) following at least one systemic 1st-line treatment\n* Requiring treatment according to IWCLL criteria (appendix A);\n* Age at least 18 years;\n* ECOG\u002FWHO performance status 0-2;\n* In case of prior venetoclax treatment, enrollment can only occur at least 24 months after end of treatment and patients must not have progressed during venetoclax treatment;\n* Adequate BM function defined as:\n\n  * Hemoglobin \\>5.6 mmol\u002Fl or Hb \\> 9 g\u002FdL, unless low Hb is directly attributable to CLL infiltration of the BM, proven by BM biopsy;\n  * Absolute neutrophil count (ANC) \\>1.0 x 109\u002FL (1,000\u002FμL), unless low ANC is directly attributable to CLL infiltration of the BM, proven by BM biopsy;\n  * Platelet count \\>30 x 109\u002FL (30,000\u002FμL), unless low platelets is directly attributable to CLL infiltration in the BM;\n* Estimated Glomerular Filtration Rate (eGFR) (MDRD) or estimated creatinine clearance (CrCl) ≥ 50ml\u002Fmin (Cockcroft-Gault appendix F);\n* Adequate liver function as indicated:\n\n  * Serum aspartate transaminase (ASAT) and alanine transaminase (ALAT) ≤ 3.0 x upper limit of normal (ULN);\n  * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or controlled autoimmune hemolytic anemia);\n* Prothrombin time (PT)\u002FInternational normal ratio (INR) \\\u003C1.5x ULN and activated partial thromboplastin time (aPTT) \\\u003C1.5 x ULN; unless receiving anticoagulation;\n* Negative serological testing for hepatitis B virus (HBV) (Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) negative) and hepatitis C virus (hepatitis C antibody). Patients who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative PCR within 6 weeks before enrollment. Those who are PCR positive will be excluded; Please note: For patients positive for anti-HBc, HBV-DNA PCR has to be repeated every month until 12 months after last dose of study treatment.\n* Patient is able and willing to adhere to the study visit schedule and other protocol requirements;\n* Patient is capable of giving informed consent;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Active CLL\u002FSLL directed therapy within the last 14 days;\n* Prior treatment with a CD3 × CD20 bispecific antibody or CAR T-cell therapy\n* Transformation of CLL (Richter's transformation);\n* Prior allogeneic stem cell transplantation and\u002For solid organ transplantation;\n* Patient with a history of confirmed progressive multifocal leukoencephalopathy (PML);\n* Malignancies other than CLL currently requiring systemic therapy or not treated in curative intention or showing signs of progression after curative treatment;\n* Known allergy to xanthine oxidase inhibitors and\u002For rasburicase;\n* History of drug-specific hypersensitivity or anaphylaxis to any study drug (including active product or excipient components);\n* Active bleeding or uncontrolled severe bleeding diathesis (e.g., hemophilia or severe von Willebrand disease);\n* Active fungal, bacterial, and\u002For viral infection CTCAEgrade \\> 1; Please note: active controlled as well as chronic\u002Frecurrent infections are at risk of reactivation\u002Finfection during treatment;\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled: infection, auto-immune hemolysis, immune thrombocytopenia, diabetes, hypertension, hyperthyroidism or hypothyroidism etc.);\n* Patient known to be HIV-positive;\n* Patient requiring treatment with a strong cytochrome P450 (CYP) 3A inhibitor\u002Finducer (see appendix J) or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists;\n* CTCAE grade III-IV cardiovascular disease including but not limited to:\n\n  * Unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function, eg, unstable angina, congestive heart failure grade III or IV as classified by the New York Heart Association (see appendix E), uncontrolled clinically significant cardiac arrhythmia (CTCAE grade II or higher), or clinically significant electrocardiogram (ECG) abnormalities.\n  * Myocardial infarction, intracranial bleed, or stroke within the past 6 months.\n  * Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \\>480 msec. NOTE: this criterion does not apply to subjects with a left bundle branch block.\n  * Stroke or intracranial hemorrhage within 6 months prior to registration.\n* Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);\n* Severe neurological or psychiatric disease (CTCAE grade III-IV, see appendix D);\n* Neuropathy \\> CTCAE grade II\n* Patient who has difficulty with or are unable to swallow oral medication, or have significant gastrointestinal disease that would limit absorption of oral medication;\n* Vaccination with live vaccines within 28 days prior to registration;\n* Use of any other experimental drug or therapy within 28 days of registration;\n* Major surgery within 28 days prior to registration;\n* Pregnant women and nursing mothers;\n* Fertile men or women of childbearing potential unless: (1) surgically sterile or ≥ 2 years after the onset of menopause; (2) willing to use a highly effective contraceptive method such as oral contraceptives, intrauterine device, sexual abstinence or combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) during study treatment and for 12 months after last dose of epcoritamab and 30 days after last dose of venetoclax;\n* Previous participation in the HOVON 139 CLL or HOVON 140 CLL trial and eligible for and willing to participate in the HOVON 159 CLL trial;\n* Current participation in other clinical trial with medicinal products;\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":244,"type":21},112,[51,80],"In this study, efficacy and safety of 2 regimens that combine the CD3-CD20 T cell engager epcoritamab with venetoclax will be tested in relapsed\u002Frefractory CLL and SLL patients. The trial starts with phase I part to establish the recommended dose level (RDL) of epcoritamab in the combination with venetoclax for the phase II trial.",[27],"2024-04-10",{"date":250,"type":32},"2024-04-12",{"date":248,"type":32},{"date":253,"type":21},"2032-11",{"name":120,"class":101},24,{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":268,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100509810","phase-2-clinical-study-of-orelabrutinib-combined-with-bg-regimen-first-line-treatment-of-cllsll-100509810","NCT05918276","Clinical Study of Orelabrutinib Combined With BG Regimen First-line Treatment of CLL\u002FSLL","Exploratory Clinical Study of Orelabrutinib in Combination With BG Regimen in Patients With Naive and Unfit CLL\u002FSLL Without 17p- or TP53 Mutations","CLL-OBG","Inclusion Criteria:\n\n* 65 years of age and older or between 18 and 65 years of age with severe illness (non-CLL\u002FSLL associated CIRS ≥ 6);\n* ECOG performance status (PS) level 0\\~2；\n* Expected survival is not less than 12 weeks;\n* Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma diagnosed by flow cytometry or histopathology according to IWCLL2008 criteria, and CD20 positive;\n* Meet at least 1 indication for treatment according to IWCLL2008 criteria or Chinese CLL\u002FSLL guidelines 2022\n* Enhanced computed tomography\u002Fmagnetic resonance imaging (CT\u002FMRI) to detect measurable lesions: at least one lymph node with a maximum axis of more than 1.5 cm and one measurable vertical dimension; for patients with chronic lymphocytic leukemia, only peripheral circulating lymphocyte count must be \\> 5000\u002FμL (or 5×10\\^9\u002FL);\n* Have not received systematic treatment for CLL\u002FSLL in the past;\n* The main organs are functioning normally, the following criteria are met:\n\n  1. Routine blood test standards should meet:\n\n     Absolute neutrophil (ANC) ≥1.0×109\u002FL, platelet (PLT) ≥30×109\u002FL; unless bone marrow and hematopoietic insufficiency is confirmed to be due to CLL\u002FSLL\n  2. Biochemical examination should meet the following standards:\n\n     1. TBIL\\\u003C2.0× ULN, CLL\u002FSLL liver involvement or confirmed Gilbert syndrome (normal direct bilirubin), total bilirubia ≤ 3 times ULN;\n     2. ALT and AST \\\u003C2.5×ULN (ALT and AST \\\u003C5×ULN for CLL\u002FSLL liver involvement);\n     3. Endogenous creatinine clearance ≥ 30 ml\u002Fmin (Cockcroft-Gault formula).\n* Women of childbearing age must have taken reliable contraceptive measures or have taken a pregnancy test (serum or urine) within 7 days prior to enrollment, have a negative result, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, consent to appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the test drug must be agreed;\n* Subjects voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with 17P- chromosome abnormalities or TP53 mutations;\n* Current or previous biopsy pathology confirms conversion to Richter's syndrome;\n* Have active and uncontrolled autoimmune cytopenias, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura;\n* Patients with central nervous system invasion;\n* Glucocorticoid therapy (at a dose equal to or greater than 20 mg\u002Fday of prednisone or equivalent) within 14 days prior to the first dose, excluding inhalation, topical medication, intra-articular medication, and prophylaxis before or after iodine contrast use; After discussion with the team leader, higher doses, longer steroid therapy may be allowed in the following cases:\n\n  1. treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL\u002FSLL disease;\n  2. Acute exacerbations due to short-term (within 14 days) use of inactive infections for diseases not associated with CLL\u002FSLL (e.g., arthritis, asthma), including steroid dose adjustment required for adrenal insufficiency;\n* Previous or concurrent uncured malignant tumors, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer;\n* Suffering from the following cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval QTc \\>480ms); According to NYHA standards, grade III.\\~IV. cardiac insufficiency, or cardiac ultrasound showed left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Coagulation dysfunction (INR\\>1.5 or prothrombin time (PT) \\>ULN+4 seconds or APTT \\>1.5 ULN), bleeding tendency or receiving thrombolysis or anticoagulation therapy;\n* Arteriovenous thrombotic events that occurred within 12 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;\n* Known hereditary or acquired bleeding and thrombosis (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);\n* Have undergone major surgical procedures or developed severe traumatic injuries, fractures or ulcers within 4 weeks of enrollment;\n* Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction;\n* Active infection requiring antimicrobial therapy (such as antibacterial drugs and antiviral drugs, excluding chronic hepatitis B anti-hepatitis B treatment and antifungal treatment);\n* Active hepatitis B (HBV DNA≥2000 IU\u002FmL or 10000 copy number\u002FmL) or hepatitis C (positive for hepatitis C antibodies and HCV RNA above the lower limit of the assay);\n* Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;\n* Have participated in clinical trials of other antitumor drugs within 4 weeks before enrollment;\n* Those who have received strong CYP3A4 inhibitor therapy within 7 days before enrollment, or received strong CYP3A4 inducer therapy within 12 days before participating in the study;\n* Pregnant or lactating women; Patients of childbearing potential who are unwilling or unable to use effective contraception; 19. Other circumstances that may affect the conduct of clinical research and the determination of research results as determined by the investigator.",{"count":255,"type":21},[80],"This study aims to investigate the treatment of navie CLL\u002FSLL with orelabrutinib, bendamustine and obinutuzumab . The primary endpoint is the rate of CR and uMRD, and the second endpoints are survival time (OS and PFS) and toxicities.",[27],[269,270,271],"Orelabrutinib","bendamustine","obintuzumab","2023-06-15",{"date":274,"type":32},"2023-06-26",{"date":276,"type":21},"2023-07-15",{"date":278,"type":21},"2026-12-30",{"name":280,"class":101},"Nanfang Hospital, Southern Medical University",2]