[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"German CLL Study Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,75,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100577030","a-prospective-observational-trial-to-assess-treatment-sequences-and-factors-that-impact-overall-sur-vival-in-patients-with-chronic-lymphocytic-leukaemia-cll-treated-within-first-line-studies-of-the-gcllsg-100577030",false,"NCT06792994","A Prospective Observational Trial to Assess Treatment Sequences and Factors That Impact Overall Sur-vival in Patients With Chronic Lymphocytic Leukaemia (CLL) Treated Within First-line Studies of the GCLLSG","CLL2000","Inclusion Criteria:\n\n* • Subjects must voluntarily sign and date an informed consent, ap-proved by an independent ethics committee (IEC)\u002Finstitutional review board (IRB)\n\n  * Documented diagnosis of CLL at time point of inclusion in a first-line study of the GCLLSG (development of RT is not an exclusion criterion)\n  * First-line treatment was administered within one of these first-line studies of the GCLLSG (CLL13, CLL14, or CLL17).\n  * Subsequent therapy lines were either documented during the participa-tion in a first-line study of the GCLLSG or patient consented to have the subsequent therapy lines documented within this observational trial.\n  * Subjects are willing and able to comply with procedures required in this protocol.\n\nExclusion Criteria:\n\n* • Patients without participation in one of the first-line studies of the GCLLSG (CLL13, CLL14, CLL17)\n\n  * Subjects with legal incapacity\n  * Subjects who are institutionalized by regulatory or court order\n  * Subjects who are in dependence to the sponsor or the investigator","ALL","18 Years","99 Years",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","This observational trial is designed to investigate long-term survival with regard to the primary endpoint overall survival (OS) after start of first-line treatment.",[25],"Chronic Lymphocytic Leukemia",[27],"Long-term observation, CLL","RECRUITING","2026-04-27",{"date":31,"type":32},"2026-04-30","ACTUAL",{"date":34,"type":32},"2026-04-02",{"date":36,"type":21},"2030-08-01",{"name":38,"class":39},"German CLL Study Group","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":62,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"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":50,"type":21},8000,"25 Years","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",[54,55,56,57,58,59,60,61],"CLL","SLL","HCL","Richter´s Transformation","Leukemia, Prolymphocytic, B-Cell","Leukemia, Prolymphocytic, T-Cell","T-LGL Leukemia","NK-LGL Leukemia",[54,63,64,55,65,56,57],"B-PLL","T-PLL","T-NK-LGL","2025-12-01",{"date":68,"type":32},"2025-12-08",{"date":70,"type":4},"2013-08",{"date":72,"type":21},"2026-12",{"name":38,"class":39},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100454411","phase-3-a-phase-3-trial-of-acalabrutinib-obinutuzumab--venetoclax-compared-to-obinutuzumab-and-venetoclax-in-previously-untreated-patients-with-high-risk-cll-100454411","NCT05197192","A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL","A Prospective, Open-label, Multicentre, Randomized, Phase-3-trial of Acalabrutinib, Obinutuzumab and Venetoclax (GAVE) Compared to Obinutuzumab and Venetoclax (GVE) in Previously Untreated Patients With High Risk Chronic Lymphocytic Leukemia (CLL)","Inclusion Criteria:\n\n* Documented CLL\u002FSLL requiring treatment according to iwCLL criteria\n* Age at least 18 years\n* At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status.\n* Life expectancy ≥ six months\n* Adequate bone marrow function indicated by a platelet count \\>30 x10\\^9\u002Fl\n* Creatinine clearance ≥ 30ml\u002Fmin\n* Adequate liver function as indicated by a total bilirubin ≤ 2 x, AST\u002F ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome\n* Negative testing for hepatitis B (HbsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last treatment cycle),or hepatitis C (negative testing for hepatitis C RNA within 6 wee\n* ks prior to registration for study screening (i.e. PCR only required when serology was positive))\n* ECOG (Eastern Cooperative Oncology Group Performance Status) status 0-2\n\nExclusion Criteria:\n\n* Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisolone are permitted)\n* Absence of high risk disease (17p-deletion, TP53-mutation complex karyotype\n* An individual organ\u002Fsystem impairment score of 4 as assessed by the CIRS definition (e.g. advanced cardiac disease (NYHA class 3 or 4) limiting the ability to receive the study treatment or any other life-threatening illness, medical condition or organ system dysfunction that, in the investigator´s opinion, could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g. inability to swallow tablets or impaired resorption in the gastrointestinal tract)\n* Transformation of CLL (Richter transformation)\n* Malignancies other than CLL currently requiring systemic therapies\n* Uncontrolled or active infection of HIV\u002FPML or any other active infection\n* Anticoagulant therapy with warfarin or phenoprocoumon\n* Pregnant women and nursing mothers","120 Years",{"count":84,"type":21},202,"INTERVENTIONAL",[87],"PHASE3","This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation, complex karyotype or an unmutated IGHV-gene status).",[25],[54,91,92,93,94],"high risk","tp53 aberration","complex karyotype","unmutated IGHV gene status","2025-08-13",{"date":97,"type":32},"2025-08-17",{"date":99,"type":32},"2022-04-19",{"date":101,"type":21},"2028-05",{"name":38,"class":39},30,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":85,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100383384","phase-2-efficacy-and-safety-of-zanubrutinib-plus-tislelizumab-treatment-with-or-without-sonrotoclax-for-patients-with-richter-transformation-100383384","NCT04271956","Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation","A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of Zanubrutinib (BGB-3111), a BTK Inhibitor, Plus Tislelizumab (BGB-A317), a PD1 Inhibitor, for Treatment of Patients with Richter Transformation with or Without Sonrotoclax（BGB-11417), a Bcl-2 Inhibitor (CLL-RT1-trial of the GCLLSG).","CLL-RT1","Inclusion Criteria:\n\n1. Confirmed diagnosis of CLL according to iwCLL criteria (Hallek et al, 2018)\n2. Confirmed histopathological diagnosis of RT (diffuse large B-cell lymphoma or Hodgkin's lymphoma \\[Hodgkin's lymphoma only when not eligible for more in-tensive treatment\\])\n3. Previously untreated RT or patients with objective response or non-tolerance to first-line RT treatment\n4. Adequate bone marrow function as defined by:\n\n   * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3, except for patients with bone marrow involvement in which ANC must be ≥ 500\u002Fmm3\n   * Platelet ≥ 75,000\u002Fmm3, except for patients with bone marrow involvement in which the platelet count must be ≥ 30,000\u002Fmm3\n5. Creatinine clearance ≥30ml\u002Fmin calculated according to the modified formula of Cockcroft and Gault or directly measured with 24hr urine collection or an equivalent method.\n6. Adequate liver function as indicated by a total bilirubin≤ 2 x, AST\u002FALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL\u002FRT or to Gilbert's Syndrome, in which case a max. total bilirubin ≤ 3 x and AST\u002FALT ≤ 5 x the institutional ULN value are required.\n7. Negative serological testing for hepatitis B (HBsAg negative and anti-HBc nega-tive; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every two months until 2 months af-ter last dose of zanubrutinib), negative testing for hepatitis-C RNA and negative HIV test within 6 weeks prior to registration\n8. Age at least 18 years\n9. ECOG performance status 0-2, ECOG 3 is only permitted if related to CLL or RT (e.g. due to anaemia or severe constitutional symptoms)\n10. Life expectancy ≥ 3 months\n11. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n1. Patients who did not respond to previous line of RT therapy (i.e. primary progressive patients)\n2. Patients with more than one prior line of RT therapy\n3. Allogenic stem cell transplantation within the last 100 days or signs of active GVHD after prior allogeneic stem cell transplantation within any time\n4. Patients with confirmed PML\n5. Uncontrolled autoimmune condition\n6. Malignancies other than CLL currently requiring systemic therapies (unless the malignant disease is in a stable remission at the discretion of the treating phy-sician)\n7. Uncontrolled infection currently requiring systemic treatment\n8. Any comorbidity or organ system impairment rated with a CIRS (cumulative ill-ness rating scale) score of 4, excluding the eyes\u002Fears\u002Fnose\u002Fthroat\u002Flarynx organ system , or any other life-threatening illness, medical condition or organ system dysfunction that - in the investigator´s opinion could comprise the patients safety or interfere with the absorption or metabolism of the study drugs\n9. Requirement of therapy with strong CYP3A4 inhibitors\u002F inducers\n10. Requirement of therapy with phenprocoumon or other vitamin K antagonists.\n11. Known active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:\n\n    * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core anti-body (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (\\\u003C 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation.\n    * Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable.\n12. Major surgery within 4 weeks of the first dose of study drug.\n13. Any uncontrolled or clinically significant cardiovascular disease including the following:\n\n    * Myocardial infarction within 6 months before screening\n    * Unstable angina within 3 months before screening\n    * New York Heart Association class III or IV congestive heart failure\n    * History of clinically significant arrhythmias (eg, sustained ventricular tachy-cardia, ventricular fibrillation, torsades de pointes)\n14. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood trans-fusion or other medical intervention\n15. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n16. Severe or debilitating pulmonary disease\n17. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n18. Use of investigational agents, e.g. monoclonal antibodies or other experimental drugs within clinical trials, which might interfere with the study drug within 28 days (or 5 times half-life \\[t1\u002F2\\] of the compound, whichever is longer) prior to registration\n19. Known hypersensitivity to tislelizumab, zanubrutinib, sonrotoclax or any of the excipients\n20. Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment)\n21. Fertile men or women of childbearing potential unless:\n\n    * surgically sterile or ≥ 2 years after the onset of menopause, or\n    * willing to use two methods of reliable contraception including one highly ef-fective contraceptive method (Pearl Index \\\u003C1) and one additional effective (barrier) method during study treatment and for 6 months after the end of study treatment.\n22. Vaccination with a live vaccine \\\u003C28 days prior to randomization\n23. Legal incapacity\n24. Prisoners or subjects who are institutionalized by regulatory or court order\n25. Persons who are in dependence to the sponsor or an investigator",{"count":113,"type":21},83,[115],"PHASE2","The aim of the CLL-RT1 trial is to evaluate the efficacy and safety of zanubrutinib (BGB-3111), a BTK inhibitor plus tislelizumab (BGB-A317), a PD1 inhibitor for treatment of patients with Richter Transformation",[118],"Richter Transformation","2024-12-27",{"date":121,"type":32},"2024-12-30",{"date":123,"type":32},"2020-02-19",{"date":125,"type":21},"2026-08",{"name":38,"class":39},11,""]