[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sll\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sll":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,103,134,167,192],{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100512084","phase-3-a-study-of-nemtabrutinib-plus-venetoclax-vs-venetoclax--rituximab-vr-in-second-line-2l--relapsedrefractory-rr-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-mk-1026-010bellwave-010-100512084",false,"NCT05947851","A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed\u002FRefractory (R\u002FR) Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) (MK-1026-010\u002FBELLWAVE-010).","A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax Versus Venetoclax Plus Rituximab in Participants With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma Following at Least 1 Prior Therapy (BELLWAVE-010)","Inclusion Criteria:\n\n* Confirmed diagnosis of chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL) and active disease clearly documented to initiate therapy\n* Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV) mutation status results required before randomization for Part 2 participants only\n* Relapsed or refractory to at least 1 prior available therapy\n* Have at least 1 marker of disease burden\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization\n* Has a life expectancy of at least 3 months\n* Has the ability to swallow and retain oral medication\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening\n* Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria\n* Participants with adequate organ function with specimens collected within 7 days before the start of study intervention\n* If capable of producing sperm, participant agrees to eliminate Nemtabrutinib: 12 days, Venetoclax: 1 month (30 days), Rituximab (rituximab biosimilar): not applicable; abstains from penile-vaginal intercourse as their preferred and usual lifestyle; OR uses prescribed contraception\n* Participant assigned female sex at birth are eligible to participate if not pregnant or breastfeeding and are not a person of childbearing potential (POCBP) OR is a POCBP and uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, and abstains from breastfeeding\n\nExclusion Criteria:\n\n* Has an active hepatitis B virus\u002F hepatitis C virus (HBV\u002FHCV) infection\n* Has gastrointestinal (GI) dysfunction that may affect drug absorption\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL\u002FSLL\n* Has an active infection requiring systemic therapy, such as intravenous (IV) antibiotics, during screening\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease and\u002For acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening\n* Clinically significant cardiovascular disease\n* Has a known allergy\u002Fsensitivity to nemtabrutinib or contraindication to venetoclax\u002Frituximab (or rituximab biosimilar), or any of the excipients\n* Has history of severe bleeding disorders (eg, hemophilia)\n* Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before randomization\n* Has received prior B-cell lymphoma 2 inhibitor(s) (BCL2i) within ≤ 12 months before randomization or has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids\n* Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.\n* Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention\n* Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration\n* Has a known psychiatric or substance use disorder that would interfere with the participant's ability to cooperate with the requirements of the study\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications","ALL","18 Years",{"count":19,"type":20},735,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R\u002FR CLL\u002FSLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).",[26,27,28,29,30,31],"Leukemia, Lymphocytic, Chronic, B-Cell","Leukemia, Chronic Lymphocytic","Small-Cell Lymphoma","Lymphoma, Small Lymphocytic","CLL","SLL","RECRUITING","2026-05-14",{"date":35,"type":36},"2026-05-18","ACTUAL",{"date":38,"type":36},"2023-08-08",{"date":40,"type":20},"2035-07-01",{"name":42,"class":43},"Merck Sharp & Dohme LLC","INDUSTRY",54,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100619273","phase-3-rocket-cll-global-phase-3-study-rocbrutinib-vs-pirtobrutinib-in-cbtki-pretreated-rr-cllsll-100619273","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);",{"count":53,"type":20},306,[23],"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.",[57,58,59,60,61,31,30,62],"CLL \u002F SLL","CLL (Chronic Lymphocytic Leukemia)","CLL, Refractory","CLL, Relapsed","SLL (Small Lymphocytic Lymphoma)","CLL Progression",[64,65,66,67,68,69,70,71,30,31,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"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","2026-05-12",{"date":33,"type":36},{"date":97,"type":36},"2026-04-23",{"date":99,"type":20},"2030-07-30",{"name":101,"class":43},"Newave Pharmaceutical Inc",4,{"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":21,"phases":112,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":133},"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":111,"type":20},22,[113],"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.",[72,30,31,116,117,118,119],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Small Lymphocytic Lymphoma Variant","Chronic Lymphocytic Leukemia Variants",[121,122],"Epcoritamab","Obinutuzumab","2026-01-02",{"date":125,"type":36},"2026-01-06",{"date":127,"type":36},"2025-08-22",{"date":129,"type":20},"2029-07-01",{"name":131,"class":132},"Zulfa Omer","OTHER",1,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":144,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":154,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":133},"100275317","registry-of-the-german-cll-study-group-100275317","NCT02863692","Registry of the German CLL Study Group","Registry of the German CLL Study Group Long Term Follow-up of Patients With CLL, B-PLL, T-PLL, SLL,T or NK-LGL, HCL and Richter's Transformation","CLL-Registry","Inclusion Criteria (all must apply)\n\n1. Confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK-LGL, HCL or Richter's transformation\n2. 18 years of age or older\n3. Signed, written informed consent\n4. Presence of one or more of the following disease situations:\n\n   * Newly diagnosed patients without treatment indication (eligible for watch and wait Approach Treatment within a clinical trial according to the AMG or status post participation in a clinical Trial)\n   * Treatment with standard therapies approved for the eligible entities or status post treatment (outside of clinical trials)\n   * Referral for evaluation the indication for HSCT\n   * Relapsed disease status (even if first diagnosis was prior to activation of the registry)\n\nExclusion Criteria\n\n1. Patients without confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK- LGL, HCL or Richter's transformation\n2. Cerebral dysfunction, legal incapacity",{"count":143,"type":20},8000,"25 Years","OBSERVATIONAL","Long term follow-up of patients with chronic lymphocytic leukemia (CLL), B-prolymphocytic leukemia (B-PLL), T-cell prolymphocytic leukemia (T-PLL), Small lymphocytic lymphoma (SLL), T\u002FNatural Killer large granular lymphocyte leukemia (T or NK-LGL), Hairy cell leukemia (HCL) and Richter's transformation",[30,31,148,149,150,151,152,153],"HCL","Richter´s Transformation","Leukemia, Prolymphocytic, B-Cell","Leukemia, Prolymphocytic, T-Cell","T-LGL Leukemia","NK-LGL Leukemia",[30,155,156,31,157,148,149],"B-PLL","T-PLL","T-NK-LGL","2025-12-01",{"date":160,"type":36},"2025-12-08",{"date":162,"type":4},"2013-08",{"date":164,"type":20},"2026-12",{"name":166,"class":132},"German CLL Study Group",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":133},"100602217","anti-cd19-car-t-combined-with-btki-to-treat-newly-diagnosed-high-risk-cllsll-100602217","NCT07120633","Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL\u002FSLL","The Efficacy of AntiCD19 CAR-T Combined With BTKi in the Treatment of Newly Diagnosed High-risk CLL Patients, and to Explore Its Efficacy and Safety of Limited-term Treatment in These Patients","Inclusion Criteria:\n\n1. The patient voluntarily participates and signs the informed consent form;\n2. Age ≥18 years old;\n3. Confirmed as CLL\u002FSLL according to WHO standards, and confirmed positive expression of CD19 through flow cytometry or immunohistochemical detection;\n4. Subjects:\n\n   4.1 First-time patients who have not received systemic radiotherapy or chemotherapy in the past. (Except for the following situations: Short-term systemic corticosteroids for disease control, improvement of performance status or treatment of non-cancer indications (use for ≤14 days, prednisone \\\u003C100 mg\u002Fd or dexamethasone ≤20 mg\u002Fd). Steroids must be discontinued before the study of treatment. Inhaled steroids, topical steroids and alternative corticosteroids are permitted for the treatment of asthma.\n\n   4.2 Meet the treatment indications of iwCLL 2018, including: Progressive bone marrow failure caused by bone marrow infiltration due to CLL (hemoglobin \\\u003C10 g\u002FL and platelet count \\\u003C100×10⁹\u002FL); 4.3 Patients with high-risk genetic molecular factors (del(17p), TP53 gene deletion\u002Fmutation (vaf\\>10%), U-IGHV, complex karyotype); 4.4 Have measurable or evaluable lesions (positive peripheral blood flow results or lesions ≥1cm evaluated based on PET-CT\u002FCT\u002FMRI).\n\n   4.5 No contraindications for treatment with Bruton's tyrosine kinase (BTK) inhibitors or BCL2 inhibitors.\n5. Good functions of major tissues and organs:\n\n   5.1 Liver function: ALT\u002FAST\\\u003C3 times the upper limit of the normal value and total bilirubin ≤34.2 μmol\u002FL; 5.2 Renal function: Creatinine \\\u003C 220 μmol\u002FL; 5.3 Pulmonary function: Indoor oxygen saturation ≥95%; 5.4 Cardiac function: Left ventricular ejection fraction ≥40%.\n6. The peripheral superficial veins have smooth blood circulation and can accept intravenous infusion.\n7. ECOG score ≤2;\n8. The expected survival period is more than three months.\n\nExclusion Criteria:\n\n1. CLL patients who have undergone Richter transformation;\n2. Patients known to have active malignant tumors involving the central nervous system. For patients who have previously suffered from central nervous system diseases and have received effective treatment, if they have completed treatment for at least 3 months before enrollment, have no evidence of symptomatic diseases, and the imaging examination shows abnormal stability, they will be considered for enrollment.\n3. There is a history of primary malignant tumor, and it has not been relieved for at least two years. The following situations are not subject to the two-year limit: non-melanoma skin cancer, completely resected stage 1 solid tumors with low recurrence risk, radical treatment of local prostate cancer, biopsion-revealed cervical cancer in situ or smear-revealed squamous intraepithelial lesions, and completely resected breast cancer in situ.\n4. Active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus infection;\n5. There was an uncontrollable systemic fungal, bacterial or viral infection within 4 weeks before enrollment;\n6. Have a history of any of the following cardiovascular diseases within the past 6 months: grade III or IV heart failure as defined by the New York Heart Association, angioplasty or stent implantation, myocardial infarction, unstable angina pectoris, clinically obvious arrhythmia, or other clinically significant heart diseases;\n7. Women who are pregnant (with a positive urine\u002Fblood pregnancy test) or breastfeeding;\n8. Patients who are allergic to large molecule biological drugs such as antibodies or cytokines;\n9. Had systemic hormones or immunosuppressive drugs been used within 4 weeks before enrollment (except for patients with inhaled hormones);\n10. Suffer from mental illness;\n11. The researcher determined that the patient had other conditions that made him unsuitable for inclusion in the group.",{"count":175,"type":20},50,[177],"NA","At present, there is a lack of relevant research on the first-line treatment of high-risk CLL patients with BTKi combined with CAR-T. Therefore, our center plans to conduct a study on the treatment of newly diagnosed high-risk CLL patients with AntiCD19 CAR-T combined with BTKi, in order to increase the uMRD rate of newly diagnosed high-risk patients, thereby improving the long-term prognosis of high-risk CLL patients and reducing the long-term medication rate of CLL patients, providing more treatment options and hope for newly diagnosed high-risk CLL patients.",[30,180,31],"CAR-T Cell Therapy",[182,30,31],"CAR-T","2025-08-12",{"date":185,"type":36},"2025-08-13",{"date":187,"type":20},"2025-09-01",{"date":189,"type":20},"2028-09-01",{"name":191,"class":132},"The Affiliated Hospital of Xuzhou Medical University",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":102},"100416565","phase-1-cap-100-for-subjects-with-relapsedrefractory-chronic-lymphocytic-leukemia-100416565","NCT04704323","CAP-100 for Subjects With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia","An Open Label Phase Ia\u002Fb Dose Escalation Followed by Dose Expansion Safety and Tolerability Trial of CAP-100, a Humanized C-C-chemokine Receptor 7 Antibody, Administered as Monotherapy in Subjects With r\u002Fr Chronic Lymphocytic Leukemia","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Able to understand and sign a written informed consent document.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.\n4. Relapsed or refractory to at least two (2) prior standard systemic treatment regimen for CLL or SLL (USA).\n\n   Relapsed or refractory to at least two (2) prior standard systemic treatment regimen for CLL or SLL and without available therapies known to provide clinical benefit (until new amendment implemented, Spain).\n5. Prior CLL or SLL systemic therapy must have been discontinued for a duration of at least five times its half-life (palliative low dose steroids are allowed to bridge the time to CAP-100; major surgery or irradiation for CLL must have been completed \\> 4 weeks prior to the first trial dose of medication). Prior chimeric antigen receptor (CAR)-T cell therapy is allowed.\n6. Life expectancy \\> 16 weeks.\n7. Subjects must have met the diagnostic criteria for CLL according to the iwCLL 2018 guidelines (Hallek et al, 2018) or for SLL (NCCN guidelines, 2020) at some point during their disease course.\n8. Subjects must meet iwCLL 2018 guideline criteria (Hallek et al, 2018) for active disease.\n9. Platelet count ≥ 50,000\u002F μL, unless decrease is attributable to bone marrow infiltration of CLL.\n10. Adequate liver function as indicated by aspartate transaminase (AST)\u002F alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN), unless directly attributable to the subject's tumor (in this case, acceptable levels are ≤ 5 x ULN).\n11. Renal function as defined by creatinine clearance (CrCl)≥ 45 mL\u002Fmin\u002F1.73m2 (by CKD-EPI formula).\n12. Women of childbearing potential and male subjects who have partners capable of reproduction must agree to use an effective contraceptive method during the course of the trial and for 4 months following the completion of their last treatment. Women of childbearing potential must have a negative serum β-subunit of hCG gonadotropin (β-hCG) pregnancy test result within 7 days of first trial dose. Female subjects who are surgically sterilized or who are \\> 45 years old and have not experienced menses for \\> 2 years may have β-hCG pregnancy test waived.\n\nExclusion Criteria:\n\n1. Allogeneic stem-cell transplantation within 6 months of trial entry.\n2. Monoclonal antibody for anti-cancer therapy within 4 weeks of trial entry.\n3. Side effects due to prior therapy not recovered to ≤Grade 1.\n4. Oral targeted inhibitors (Bruton's tyrosine kinase \\[BTK\\]-inhibitors, B-cell lymphoma 2 \\[BCL-2\\] inhibitors, phosphoinositide 3-kinase \\[PI3K\\] inhibitors) within five times their half-life.\n5. Active viral, bacterial or systemic fungal infection requiring treatment.\n6. Subjects who are known to be human immunodeficiency virus (HIV)-positive.\n7. Subjects with active known central nervous system (CNS) lymphoma.\n8. Pregnant or lactating women.\n9. History of previous cancer \\\u003C 2 years before the trial, except controlled disease using systemic therapy with curative intent, surgical therapy with curative intent or skin cancer, cancer in situ, and prostate cancer on the \"watch and wait\" approach.\n10. Uncontrolled intercurrent illness including, but not limited to, New York Heart Association Class (NYHA) III and IV congestive heart failure, myocardial infraction within the previous 6 months, ejection fraction (EF) \\\u003C 40%, life-threatening arrhythmias, or unstable angina brain metastasis or psychiatric illness that would limit compliance with trial requirement.\n11. Subjects with known hypersensitivity to any excipient contained in the drug formulation.\n12. Subjects with a history of documented human anti-globulin antibodies.\n13. Active autoimmune disease, motor neuropathy considered of autoimmune origin, and other CNS autoimmune disease.",{"count":200,"type":20},18,[202],"PHASE1","Introduction of immuno-chemotherapy in the treatment options of CLL and SLL changed the treatment paradigm of these diseases. Presently, first-line therapies for CLL\u002FSLL include targeted therapies (e.g. ibrutinib, acalabrutinib) or combined immuno-chemotherapy regimens (e.g., fludarabine, cyclophosphamide, and rituximab for patients aged \\\u003C65 years without del17p\u002FTP53 mutations or bendamustine and rituximab for patients ≥65 years who have additional comorbidities).\n\nDespite the gradual introduction of targeted therapies, new treatment strategies efficacious for patients ineligible for\u002Funresponsive to these therapies are still required. These new strategies should ideally overcome disease relapse and circumvent compound-specific safety challenges. Emerging treatment options include new compounds aimed for both untreated and relapsed\u002Frefractory CLL, and combination therapies of existing compounds that extend single-agent efficacy in specific high-risk patient populations.\n\nCAP-100 is expected to prevent the migration of leukemia cells to and their survival in lymphoid niches as well as to eliminate CCR7-positive leukemia cells via ADCC, resulting in measurable clinical responses.\n\nThe present trial is the first-in-human trial of CAP-100 and is divided into two phases. The aim of the Phase Ia (dose escalation) is to define the Recommended Phase 2 Dose (RP2D) versus the Maximum Tolerated Dose (MTD) of CAP-100 in subjects with CLL.\n\nPhase Ib of the trial (expansion phase) will evaluate the safety and preliminary clinical benefit of CAP-100 monotherapy at RP2D (response rate, lymph node size reduction, assessment of minimal residual disease \\[MRD\\]) to support the design of future trials investigating CAP-100 either as monotherapy or in a combination setting with approved treatments for CLL.",[205,31],"Lymphocytic Leukemia, Chronic","2025-07-14",{"date":208,"type":36},"2025-07-17",{"date":210,"type":36},"2021-09-10",{"date":212,"type":20},"2027-04",{"name":214,"class":43},"Catapult Therapeutics"]