[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-lymphocytic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-lymphocytic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100458832","phase-3-a-study-of-pirtobrutinib-loxo-305-versus-ibrutinib-in-participants-with-chronic-lymphocytic-leukemia-cllsmall-lymphocytic-lymphoma-sll-100458832",false,"NCT05254743","A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (BRUIN-CLL-314)","BRUIN-CLL-314","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL\u002FSLL requiring therapy per iwCLL 2018 criteria\n* Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Adequate organ function\n\n  * Platelets greater than or equal to ≥ 50 x 10⁹\u002Fliter (L) or ≥30 x 10⁹\u002FL in participants with documented bone marrow involvement considered to impair hematopoiesis,\n  * Hemoglobin ≥8 grams\u002Fdeciliter (g\u002FdL) or ≥6 g\u002FdL in participants with documented bone marrow involvement considered to impair hematopoiesis\n  * Absolute neutrophil count ≥0.75 x 10⁹\u002FL or ≥0.50 × 10⁹\u002FL in participants with documented bone marrow involvement considered to impair hematopoiesis\n  * Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment\n* Known or suspected central nervous system (CNS) involvement\n* A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease\n* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\])\n* Significant cardiovascular disease including ejection fraction \\\u003C 40% and any grade ongoing atrial fibrillation or atrial flutter\n* Hepatitis B or hepatitis C testing indicating active\u002Fongoing infection, based on Screening laboratory tests\n* Active cytomegalovirus (CMV) infection\n* Active uncontrolled systemic bacterial, viral, or fungal infection\n* Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count\n* Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments\n* Ongoing inflammatory bowel disease\n* Previous treatment for CLL\u002FSLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).\n\nPart 2: participants must be treatment naïve\n\n* Concurrent use of investigational agent or anticancer therapy except hormonal therapy\n* Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist\n* Use of \\> 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug\n* Vaccination with a live vaccine within 28 days prior to randomization\n* Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment\n* Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib","ALL","18 Years",{"count":20,"type":21},737,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL\u002FSLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL\u002FSLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.",[27,28,29,30],"Chronic Lymphocytic Leukemia","Leukemia, Lymphocytic","Leukemia, B-cell","Small Lymphocytic Lymphoma",[32,33,34,35],"BTKi","Hematologic Disease","Lymphoma, non-Hodgkin's","Lymphoma, B-cell","RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-17","ACTUAL",{"date":42,"type":40},"2022-07-22",{"date":44,"type":21},"2028-01",{"name":46,"class":47},"Loxo Oncology, Inc.","INDUSTRY",143,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100551604","phase-2-anti-cd19-chimeric-antigen-receptor-modified-t-cell-car-t-therapy-for-treatment-of-b-cell-hematological-malignancies-100551604","NCT06462248","Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies","A Single Arm, Open-labelled Phase II Clinical Trial of Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) for Treatment of B-cell Haematological Malignancies","Inclusion Criteria:\n\nAcute Lymphoblastic Leukaemia\n\n* Paediatric or adult patients with relapsed or refractory CD19+ B cell ALL. (Age 0-60 years). Patients should be in first or subsequent relapse, or relapse after prior stem cell transplant, or persistent Minimal Residual Disease (MRD) positive disease\n* ECOG performance score of ≤2 if \\>16 years old, or Lansky performance score of \\>50 if ≤16 years old at screening\n* Post allogeneic stem cell transplant patients with B cell ALL will be eligible \\> 3 months after transplant and off immunosuppression for at least 1 month.\n* Patients with active leukaemia who developed significant organ impairment that cannot tolerate conventional chemotherapy,\n* For women of childbearing potential, a negative pregnancy test prior to apheresis\n\nB-cell lymphoma\n\n* Patients with histologically confirmed refractory Diffuse Large B-cell Lymphoma, primary mediastinal B cell lymphoma or transformed follicular lymphoma or other B-cell lymphoma according to WHO classification\n* Confirmed CD19 positivity status in tissue sample obtained at diagnosis or relapse\n* Received at least two prior treatment which must include at least one intensive systemic therapy.\n* Disease progression or relapsed disease within 12 months after autologous stem cell transplant\n* ECOG performance score of ≤2 if \\>16 years old, or Lansky performance score of \\>50 if ≤16 years old at screening\n* Has sufficient organ function to tolerate treatment with CAR-T cell therapy\n* For women of childbearing potential, a negative pregnancy test prior to apheresis\n\nExclusion criteria of both cohorts\n\n* Patients with active infection\n* Patients with B cell ALL post allogeneic transplant with active GVHD or on immunosuppression\n* Recent donor lymphocyte infusion (DLI) after allogeneic transplant, less than 6 weeks between DLI and CAR T infusion\n* Current autoimmune disease, or history of autoimmune disease with potential CNS involvement\n* Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischaemia or haemorrhage, dementia, paralysis)\n* Patients who are positive for HBsAg, HCV RNA positive or with HIV infection\n* Pulmonary function: Grade 1 dyspnea and pulse oxygenation \\> 91% on room air\n* Cardiac function: Fractional shortening \\\u003C28% or left ventricular ejection fraction \\\u003C45% by echocardiography.\n* Renal function: Creatinine clearance \\\u003C50 mL\u002Fmin\u002F1.73 m2\n* Liver function: Patients with a serum bilirubin \\>3 times upper limit of normal or an AST or ALT \\> 5 times upper limit of normal, unless due to leukaemic liver infiltration in the estimation of the investigator\n* Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy.","1 Year",{"count":58,"type":21},20,[60],"PHASE2","CAR-T therapy is now available as a commercial product for treatment of relapsed \u002Frefractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive. It is imperative to develop cost effective, closed circuit manufacturing systems for CAR-T cells to make CAR-T cells a point-of care production option. Hong Kong Institute of Biotechnology has established a certified GMP facility and utilize the Prodigy system to manufacture CAR-T cells for clinical application. Prince of Wales Hospital and Hong Kong Children's Hospital will conduct the phase II clinical trial to confirm the efficacy and safety of local manufactured CAR-T cell product.",[63,28],"Lymphoma, Nonhodgkin",[65,66],"relapsed leukemia","relapsed B-cell lymphoma","2024-06-14",{"date":69,"type":40},"2024-06-17",{"date":71,"type":40},"2024-06-01",{"date":73,"type":21},"2027-12-31",{"name":75,"class":76},"Chi Kong Li","OTHER",1]