[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cll\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cll":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,39,67,95,122,180,206,233,265,290,319,352,373,390,413,440],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100486142","study-of-the-metabolism-in-the-lymphatic-niche-of-cll-100486142",false,"NCT05610228","Study of the Metabolism in the Lymphatic Niche of CLL","Study of the Metabolic Reprogramming of CLL Cells in Ex-vivo Models of the Lymphatic Niche","Inclusion Criteria:\n\n* Patients for whom the diagnosis of CLL has been established cytologically and phenotypically (Matutes score)\n* Patients over 18 years old\n* Patients who have signed the non-objection form\n* Untreated patients\n\nExclusion Criteria:\n\n* Patient with a solid cancer that is progressive or in remission for less than 3 years\n* HIV positive patients\n* Patients with chronic active hepatitis B or C\n* History of allogeneic transplant","ALL","18 Years","90 Years",{"count":20,"type":21},30,"ESTIMATED","OBSERVATIONAL","Chronic lymphoid leukemia (CLL) is the most common adult leukemia that is characterized by a malignant monoclonal accumulation of tumoral and quiescent B cells in the peripheral blood. In advanced stages of the disease (Binet stage C), this population invades the bone marrow (BM) and proliferate into the lymphoid organs that results in widespread adenopathy. Richter's transformation is a most aggressive serious complication of CLL (transformation of the disease into an aggressive lymphoma) detected based on TEP\u002FCT (Positron Emission Tomography\u002F computerized tomography) that shows highly derived glucose consumption by cancer cells. Clinical data from CLL patients with disease acutisation showed hypermetabolic lymphadenopathy with high standardized uptake value (SUV) whereas there is low grade tracer uptake into BM. We supposed that the tumor microenvironment of the lymphatic niche promotes the proliferation and glycolytic activity of CLL cells which become particularly resistant to treatment. The development of an ex-vivo tumor model that reproduces the microenvironment of the lymph node niche appears essential to identify and validate new therapeutic targets because despite the therapeutic arsenal available some patients still relapse or are refractory to treatment. Our objectives are to i \u002F Characterize this niche of resistance by the development of an ex-vivo tumor model and ii \u002F Evaluate in-vitro the effectiveness of the association of current treatments (RFC, Ibrutinib or Venetoclax) with anti-metabolic therapies (inhibitors of glycolysis) Our lab is developing an ex-vivo models of the lymphatic niche in CLL based on co-cultures of leukemic cells from patients stimulated with CpG ODN and IL2 with primary human lymphatic fibroblasts (HLF) (EC 12PP15). This co-culture has never been described in the literature and allows us to study the lymphatic niche of CLL patients. Lymph node (LN) exploration in CLL requires invasive access and does not bring any additional information in initial diagnosis. Then, we validated our co-culture model using complementary approaches: increased viability, proliferation, and resistance to Ibrutinib, associated with increased production of anti-apoptotic proteins such as MCL1 and BCL2 after 48 hours of co-culture. Secondly, we studied the metabolism in this resistance niche. We find an increased production of lactate and an acute consumption of glucose, associated with a strong metabolic activation detected by SEAHORSE and by the production of glycolysis enzymes such as hexokinase 2. Our study constitutes an original project because it characterized the energy metabolism of the CLL lymphatic niche by developing an original ex-vivo model and enhanced our understanding of the contribution of the specific microenvironment in the dissociation of metabolic activity using SUV max in BM and lymphatic niche. Anti-metabolic therapies are efficient on co-culture CLL cells and could be an alternative for refractory or relapsed patients under current treatment.",[25],"CLL","RECRUITING","2026-06-25",{"date":29,"type":30},"2026-06-29","ACTUAL",{"date":32,"type":30},"2018-11-07",{"date":34,"type":21},"2027-06-25",{"name":36,"class":37},"Centre Hospitalier Universitaire de Nice","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100581158","phase-3-a-study-of-bgb-16673-compared-to-investigators-choice-in-participants-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-previously-exposed-to-both-bruton-tyrosine-kinase-btk-and-b-cell-leukemialymphoma-2-protein-bcl2-inhibitors-100581158","NCT06846671","A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia\u002FLymphoma 2 Protein (BCL2) Inhibitors","A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors","CaDAnCe-302","Inclusion Criteria:\n\n1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.\n2. Previously received treatment for CLL\u002FSLL with both a BTKi and a BCL2i.\n3. Participants with SLL must have measurable disease by computer tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2\n5. Adequate liver function\n6. Adequate blood clotting function\n\nExclusion Criteria:\n\n1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation\n2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months\n3. Known central nervous system involvement\n4. Prior exposure to any BTK protein degraders\n5. Active fungal, bacterial and\u002For viral infection requiring parenteral systemic therapy\n6. Clinically significant cardiovascular disease\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":48,"type":21},250,"INTERVENTIONAL",[51],"PHASE3","The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \\[for CLL only\\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).",[25,54],"Chronic Lymphocytic Leukemia",[25],"2026-06-18",{"date":58,"type":30},"2026-06-22",{"date":60,"type":30},"2025-04-10",{"date":62,"type":21},"2030-02-14",{"name":64,"class":65},"BeOne Medicines","INDUSTRY",120,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":49,"phases":76,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100569664","phase-1-a-study-to-investigate-the-safety-of-novel-dose-ramp-up-schedules-when-initiating-sonrotoclax-in-participants-treated-for-blood-cancers-100569664","NCT06697184","A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.","A Phase 1\u002F2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.","Inclusion Criteria:\n\n1. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.\n2. Adequate organ function and no very recent transfusion or blood growth factor\n3. Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.\n\n   Only for participants with Chronic Lymphocytic Leukemia (CLL):\n4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease\n5. At least 1 measurable lesion based on computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.\n\n   Only for participants with Mantle cell lymphoma (MCL):\n6. Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).\n7. Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.\n8. Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter.\n\nExclusion Criteria:\n\n1. Participants unable to comply with the requirements of the protocol\n2. Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n3. Positive HIV serology (HIVAb) status unless certain conditions are met.\n4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment\n5. Prior systemic treatment for the CLL\n6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment\n7. Prior exposure to a BCL-2 inhibitor\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":75,"type":21},258,[77,78],"PHASE1","PHASE2","The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.",[54,25,81,82],"Mantle Cell Lymphoma","MCL",[84,85],"CLL previously untreated","Hematological Malignancies","2026-06-05",{"date":88,"type":30},"2026-06-08",{"date":90,"type":30},"2025-01-23",{"date":92,"type":21},"2032-11-30",{"name":64,"class":65},17,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":49,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"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","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",{"count":103,"type":21},735,[51],"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).",[107,108,109,110,25,111],"Leukemia, Lymphocytic, Chronic, B-Cell","Leukemia, Chronic Lymphocytic","Small-Cell Lymphoma","Lymphoma, Small Lymphocytic","SLL","2026-05-14",{"date":114,"type":30},"2026-05-18",{"date":116,"type":30},"2023-08-08",{"date":118,"type":21},"2035-07-01",{"name":120,"class":65},"Merck Sharp & Dohme LLC",54,{"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":49,"phases":131,"briefSummary":132,"conditions":133,"keywords":140,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"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":130,"type":21},306,[51],"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.",[134,135,136,137,138,111,25,139],"CLL \u002F SLL","CLL (Chronic Lymphocytic Leukemia)","CLL, Refractory","CLL, Relapsed","SLL (Small Lymphocytic Lymphoma)","CLL Progression",[141,142,143,144,145,146,147,148,25,111,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170],"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":112,"type":30},{"date":174,"type":30},"2026-04-23",{"date":176,"type":21},"2030-07-30",{"name":178,"class":65},"Newave Pharmaceutical Inc",4,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":49,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":38},"100612860","phase-1-multicenter-single-arm-exploratory-phase-i-clinical-study-assessment-of-safety-and-efficacy-of-fully-human-baff-r-chimeric-antigen-receptor-t-cell-injection-in-relapsedrefractory-baff-r-positive-b-cell-lymphoma-100612860","NCT07259070","Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Multicenter, Single-Arm Exploratory Phase I Clinical Study on the Safety and Efficacy of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Participants With Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Inclusion Criteria:\n\n1.Relapsed and refractory (R\u002FR) BAFF-R-positive B-cell lymphoma:The diagnosis of B-cell lymphoma must be confirmed in accordance with the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (Version 1.2020) (NCCN: National Comprehensive Cancer Network).The expression of BAFF-R on tumor cells must be detected by flow cytometry (for patients where current clinical sampling is not feasible, test results obtained within 90 days prior to signing the informed consent form are acceptable). Investigators will determine whether to accept test results from external hospitals and whether the patient is eligible for enrollment.In accordance with the 2014 Lugano Classification, B-cell lymphoma patients must have at least one measurable lesion with a longest diameter ≥ 1.5 cm, or bone marrow involvement confirmed by bone marrow flow cytometry.Patients who have received CD19-targeted therapy are also eligible for enrollment, including those who have undergone:\n\n1. :Relapsed and refractory (R\u002FR) mantle cell lymphoma (MCL):Histologically confirmed MCL;Relapsed or refractory after at least 2 lines of prior treatment (including anti-CD20 monoclonal antibody and Bruton's tyrosine kinase inhibitor \\[BTKi\\]).\n2. :Relapsed and refractory (R\u002FR) chronic lymphocytic leukemia (CLL):Histologically confirmed CLL;Patients who have received at least immunochemotherapy and are refractory to both BTK inhibitors and B-cell lymphoma 2 (BCL2) inhibitors.\n3. :Relapsed and refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL):Histologically confirmed DLBCL;Patients who have received anthracycline-based therapy and anti-CD20 monoclonal antibody therapy, and have undergone at least 2 lines of treatment in total; or patients who failed to achieve remission, progressed, or relapsed within 12 months after initial standard treatment.\n4. :Relapsed and refractory (R\u002FR) follicular lymphoma (FL):Histologically confirmed FL (Grade 1-3a);Patients who have received anti-CD20 monoclonal antibody-containing therapy and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n5. :Relapsed and refractory (R\u002FR) marginal zone lymphoma (MZL):Histologically confirmed MZL;Patients who have received anti-CD20 monoclonal antibody-containing therapy, have undergone at least 2 lines of treatment in total and relapsed thereafter; or patients who relapsed within 24 months after initial treatment.\n6. :Relapsed and refractory (R\u002FR) Waldenström macroglobulinemia (WM):Histologically confirmed WM;Patients who have received anti-CD20 monoclonal antibody-containing therapy and BTK inhibitor-containing therapy (among other medications), and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n\n2.Aged ≥ 18 years and ≤ 75 years, with no restriction on gender. 3.Expected survival time ≥ 12 weeks. 4.Serum total bilirubin ≤ 37.2 μmol\u002FL (for patients with Gilbert syndrome: serum total bilirubin ≤ 3.0 × upper limit of normal \\[ULN\\], direct bilirubin ≤ 1.5 × ULN); estimated glomerular filtration rate \\[eGFR\\] (calculated by CKD-EPI formula) ≥ 30 ml\u002Fmin\u002F1.73m²; alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] \\\u003C 2.5 × upper limit of normal \\[ULN\\].\n\n5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6.Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography; oxygen saturation \\> 91%.\n\n7.The participant and their spouse\u002Fpartner must agree to use effective barrier or pharmaceutical contraceptive methods from the time the participant signs the informed consent form until one year after CAR-T cell infusion. For female participants of childbearing potential, serum or urine pregnancy test results must be negative during the screening period.\n\n8.Voluntarily participate in this trial and sign the Informed Consent Form (ICF).\n\n1. ： The patient has a full understanding of this study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).\n2. ：Aged ≥ 18 years and ≤ 75 years, with no restriction on gender.\n\nExclusion Criteria:\n\n1. Patients with a history of allergy to any component of the cellular product.\n2. Patients with acute graft-versus-host disease (aGVHD) graded as Grade II-IV according to the Glucksberg criteria, or with severity graded as Grade B-D according to the IBMTR index; patients with acute or chronic graft-versus-host disease (cGVHD) requiring systemic treatment within 4 weeks prior to enrollment.\n3. Participants who have received a live vaccine injection within 4 weeks prior to enrollment.\n4. Patients with central nervous system (CNS) diseases unrelated to lymphoma central nervous system involvement (e.g., cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, psychiatric disorders, etc.). Lymphoma central nervous system involvement or gastrointestinal tract involvement is not an exclusion criterion, but eligibility for enrollment shall be determined by the investigator.\n5. Patients with severe active infections (except uncomplicated urinary tract infections and bacterial pharyngitis), or those currently receiving intravenous antibiotic therapy. However, prophylactic use of antibiotics, antiviral drugs, and antifungal drugs is permitted.\n6. Patients who are positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B virus (HBV) DNA in peripheral blood.\n7. Patients who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood.\n8. Patients with other acquired or congenital immunodeficiency diseases, including but not limited to those positive for human immunodeficiency virus (HIV) antibody; patients with cytomegalovirus (CMV) DNA test value \\> 400 copies\u002FmL; patients with positive syphilis test results.\n9. Patients with heart failure classified as Grade III or IV according to the New York Heart Association (NYHA) Functional Classification (see Appendix II).\n10. Patients with a history of other primary malignancies, except for the following cases:Non-melanoma skin cancer (e.g., basal cell carcinoma of the skin) cured by resection;In situ carcinoma cured (e.g., cervical cancer, bladder cancer, breast cancer, etc.);Other primary malignancies with no recurrence detected for more than 5 years after treatment.\n11. Patients with a history of solid organ transplantation.\n12. Patients with a history of autoimmune diseases (predominantly characterized by abnormal cellular immunity), as well as patients with immunodeficiency or those requiring immunosuppressive therapy.\n13. Patients who received investigational drugs from other interventional clinical trials within 3 months prior to signing the Informed Consent Form (ICF).\n14. Pregnant women or women who are breastfeeding.\n15. Patients with psychiatric disorders, consciousness disturbances, or central nervous system (CNS) diseases.\n16. Patients whose toxic effects from prior treatment have not resolved to baseline or ≤ Grade 2 (per NCI-CTCAE Version 5.0, alopecia excluded).\n17. Medication use:Corticosteroids: Use of therapeutic-dose corticosteroids within 72 hours prior to CAR-T cell infusion; however, physiological-dose corticosteroid replacement is permitted (hydrocortisone \\\u003C 12 mg\u002Fm²\u002Fday or its equivalent dose)；Systemic antineoplastic therapy: Failure to discontinue systemic antineoplastic therapy for at least 2 weeks or 5 drug half-lives prior to T cell apheresis (except for BTK inhibitors in patients with CLL); the interval between T cell apheresis and the use of immune checkpoint inhibitors is less than 3 drug half-lives.\n18. Patients with active pulmonary infections.\n19. Patients with contraindications to peripheral blood apheresis.\n20. Patients deemed unsuitable for participation in this trial by the investigator after careful consideration for other reasons.","75 Years",{"count":189,"type":21},20,[77,78],"The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD).\n\nThe secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma.\n\nThe study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.",[193,25,194,82,195,196],"DLBCL","FL","WM","MZL","2026-05-10",{"date":199,"type":30},"2026-05-13",{"date":201,"type":30},"2025-11-29",{"date":203,"type":21},"2029-11-28",{"name":205,"class":37},"Institute of Hematology & Blood Diseases Hospital, China",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":49,"phases":215,"briefSummary":216,"conditions":217,"keywords":221,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":38},"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":214,"type":21},22,[78],"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.",[149,25,111,54,218,219,220],"Small Lymphocytic Lymphoma","Small Lymphocytic Lymphoma Variant","Chronic Lymphocytic Leukemia Variants",[222,223],"Epcoritamab","Obinutuzumab","2026-01-02",{"date":226,"type":30},"2026-01-06",{"date":228,"type":30},"2025-08-22",{"date":230,"type":21},"2029-07-01",{"name":232,"class":37},"Zulfa Omer",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":243,"studyType":22,"phases":4,"briefSummary":244,"conditions":245,"keywords":252,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":38},"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":242,"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",[25,111,246,247,248,249,250,251],"HCL","Richter´s Transformation","Leukemia, Prolymphocytic, B-Cell","Leukemia, Prolymphocytic, T-Cell","T-LGL Leukemia","NK-LGL Leukemia",[25,253,254,111,255,246,247],"B-PLL","T-PLL","T-NK-LGL","2025-12-01",{"date":258,"type":30},"2025-12-08",{"date":260,"type":4},"2013-08",{"date":262,"type":21},"2026-12",{"name":264,"class":37},"German CLL Study Group",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":49,"phases":274,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":38},"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":273,"type":21},50,[275],"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.",[25,278,111],"CAR-T Cell Therapy",[280,25,111],"CAR-T","2025-08-12",{"date":283,"type":30},"2025-08-13",{"date":285,"type":21},"2025-09-01",{"date":287,"type":21},"2028-09-01",{"name":289,"class":37},"The Affiliated Hospital of Xuzhou Medical University",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":297,"maxAge":187,"enrollmentInfo":298,"targetDuration":4,"studyType":49,"phases":300,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":318},"100601313","phase-1-a-phase-i-dose-finding-study-of-mb-cart22191-100601313","NCT07108868","A Phase I Dose Finding Study of MB-CART2219.1","A Phase I Dose Finding Study of MB-CART2219.1 Targeting CD19\u002FCD22 in Adult and Pediatric Patients With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n1. For Cohort I Lymphoma, adults: Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. For Cohort II ALL, pediatrics: Subject is ≥ 12 years of age at the time of signing ICF.\n3. Patient or legal guardian understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures.\n4. Able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials.\n5. CD19 or CD22 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry. Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available.\n6. Female Subject of childbearing potential and male subjects with female partner of childbearing potential is willing to use highly effective contraceptive methods during treatment until 12 months after IMP exposure.\n7. All subjects must agree to refrain from donating blood while on study drug and for 1 year after discontinuation from this study treatment.\n8. Male or female patients must have relapsed refractory (r\u002Fr) CD19 or CD22 -expressing ALL or Lymphoma\u002FCLL and meet the following disease-specific criteria.\n\n   1. Patients with r\u002Fr lymphoma with following entities according to 5th edition of the WHO Classification of Haematolymphoid Tumors after two or more systemic therapies, including one approved in label CAR-T-cell or bispecific antibody treatment option or with contraindications for such treatments:\n\n      * B-lymphoblastic lymphomas\n      * B-Chronic lymphocytic leukemia\n      * Splenic B-cell lymphoma\n      * Marginal zone lymphoma\n      * Follicular lymphoma\n      * Mantle cell lymphoma\n      * Large B-cell lymphoma\n      * Burkitt lymphoma\n      * Transformation from indolent lymphoma\n   2. Patients with r\u002Fr CLL after established and approved treatment options including therapy with BTK inhibitors have failed\n   3. Patients with lymphoma recommended for autologous or allogeneic stem cell transplant (SCT) therapy by interdisciplinary boards, but not consenting or ineligible for this treatment (including patients with refractory disease precluding allo SCT at this time, which can be included in the study as bridge to allo SCT)\n   4. Patients with lymphoma relapse after SCT, or afterCD19 or CD22 targeting therapies and with confirmed either CD19 or CD22 expression after relapse\n   5. Patients with CNS involvement by lymphoma are eligible if disease is successfully controlled at the time of inclusion\n\nExclusion Criteria:\n\n1. Subject received any of the following within the last 7 days of leukapheresis:\n\n   * Any investigational agent\n   * Immunsupressive medication\n   * Plasmapheresis\n   * Major surgery (as defined by the investigator)\n   * Radiation therapy other than local therapy for underlying malignancy\n   * Use of any systemic anti-neoplastic drug therapy or immune suppressive medication applied for graft versus-host-disease or other, including the use of high dose steroids e.g. \\>0,5 mg\u002Fkg BW methylprednisolone other than hydrocortisone replacement and other than intermittent topical, inhaled or intranasal corticosteroids which are allowed\n2. Subject has ECOG \\> 3 at screening for inclusion in the trial\n3. Subject has clinical evidence of pulmonary leukostasis, disseminated intravascular coagulation or active graft versus-host-disease\n4. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n5. Subject has any of the following laboratory abnormalities:\n\n   * Absolute neutrophil count (ANC) \\\u003C 500\u002FμL\n   * Absolute lymphocyte count \\\u003C 200\u002FµL at time of leukapheresis\n   * Platelet count \\\u003C 50,000 mm3 (platelet transfusion allowed)\n   * Serum Creatinine Clearance (CrCl) \\\u003C 45 mL\u002Fmin\n   * Corrected serum calcium \\> 13.5 mg\u002FdL (\\> 3.4 mmol\u002FL)\n   * Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN)\n   * Serum total bilirubin \\> 1.5 × ULN or \\> 3.0 mg\u002FdL for subjects with documented Gilbert's syndrome\n   * International ratio (INR) or partial thromboplastin time (PTT) \\> 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)\n6. Patient has no adequate vascular access for leukapheresis\n7. Echocardiogram (ECHO) or multi-gated acquisition (MUGA) with left ventricular ejection fraction \\\u003C 45%\n8. Patient with a history of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 3 months prior to starting study treatment\n9. Inadequate pulmonary function defined as oxygen saturation (Sa02) \\\u003C 90 % on room air\n10. Subject has history of primary immunodeficiency\n11. Subject is positive for human immunodeficiency virus (HIV-1), uncontrolled hepatitis B or C or active hepatitis A\n12. Subject with ongoing (incl. controlled) infections or infestations where inclusion of the patient into the clinical trials may significantly jeopardize the health and wellbeing of the patient, as determined by the investigator.\n13. Subject with malignancy other than the underlying malignancy in this protocol, unless this disease has been controlled for ≥ 1 year and the exception of the following noninvasive malignancies:\n\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \\[tumor, nodes, metastasis\\] clinical staging system) or prostate cancer that is curative\n14. Patient is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during participation in the study\n15. Patient with known hypersensitivity to any component of MB-CART2219.1 product, cyclophosphamide, fludarabine, and\u002For tocilizumab\n16. Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study\n17. Patient has any further condition including the presence of further laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study","12 Years",{"count":299,"type":21},36,[77],"A Phase I dose finding study of MB-CART2219.1 targeting CD19\u002FCD22 in adult and pediatric patients with relapsed\u002Frefractory B-cell malignancies",[303,25,304],"Lymphoma","Acute Lymphoblastic Leukemia, Pediatric",[306,307,308],"MB-CART2219.1 targeting CD19\u002FCD22","CD19\u002FCD22","CAR-T cells","2025-08-04",{"date":311,"type":30},"2025-08-07",{"date":313,"type":30},"2025-06-23",{"date":315,"type":21},"2027-06",{"name":317,"class":37},"University Hospital Tuebingen",2,{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":49,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":38},"100555019","phase-1-safety-and-efficacy-of-kls-1-monotherapy-in-malignant-neoplasms-100555019","NCT06506643","Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms","A Phase I\u002FII Open-label Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of KLS-1 as Monotherapy in Patients With Malignant Neoplasms","Inclusion Criteria:\n\nPhase I and Phase II - solid tumors cohorts\n\n1. Adult (male or female) aged ≥18 years.\n2. Signed informed consent prior to any study-specific procedures.\n3. Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures.\n4. Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale of:\n\n   Phase I - 0 or 1; Phase II - 0-2.\n5. Have an estimated life expectancy of ≥12 weeks.\n6. Have adequate organ function including:\n\n   a. Hematologic:\n   * ANC ≥1.5 x 109\u002FL\n   * Platelets ≥100 x 109\u002FL\n   * Hemoglobin ≥90 g\u002FL b. Hepatic:\n   * Albumin ≥30 g\u002FL\n   * Bilirubin ≤1.5 times upper limit of normal (ULN)\n   * ALT and AST ≤2.5 x ULN. If the liver has tumor involvement, AST and ALT ≤5 x ULN are acceptable.\n\n     c. Renal:\n   * Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m2 d. Blood coagulation:\n   * International Normalized Ratio (INR) or activated partial prothrombin time (aPTT) \\\u003C1.5 x ULN and \\> 0.8 x LLN lower limit of normal (LLN).\n7. Have discontinued all chemotherapy, investigational therapy, molecularly targeted therapy, and cancer-related hormonal therapy at least 30 days prior to study enrollment (6 weeks for mitomycin-C or nitrosoureas).\n8. Have discontinued biologic therapy and immunotherapy at least 21 days prior to study enrollment.\n9. Patients who have had radiation therapy must be fully recovered in the opinion of the investigator prior to enrolling on study.\n10. Are recovered or recovering from the acute adverse effects of any chemotherapy, biologic therapy, immunotherapy, molecularly-targeted therapy, cancer-related hormonal therapy, and investigational therapy (≤Grade 1 or baseline), with the exception of alopecia or Grade 2 neuropathy.\n11. Have received at least 1 but no more than 4 prior systemic therapies for CLL.\n12. Patients who have had surgery must be fully recovered in the opinion of the investigator prior to enrolling on study (but not less than 28 days for major surgery and 14 days for minor surgery).\n13. Female patients with reproductive potential must agree to use 2 forms of highly effective contraception during the study and for at least 3 months following the last dose of IMP. Sexually active male patients must use a barrier method of contraception (condom) during the study and for at least 3 months following the last dose of IMP.\n14. Females with child-bearing potential must have had a negative pregnancy test result ≤28 days prior to the first dose of IMP, as well as ≤1 day prior to the first dose of IMP.\n15. Patients must be, in the judgment of the investigator, appropriate candidates for experimental therapy, and no standard therapy would confer clinical benefit to the patients.\n16. Patients must have at least one lesion that is measurable by RECIST v.1.1.\n\nPhase I 17. Patients must have histologically proven evidence of any type of metastatic solid tumor (excluding primary brain tumor) that is evaluable and for whom no approved therapy with demonstrated clinical benefit is available or patients who are intolerant or have declined standard therapy.\n\nPhase II 18. Patients must have histologically proven evidence of a solid tumor that is locally advanced and\u002For metastatic and for whom no approved therapy with demonstrated clinical benefit is available or patients who are intolerant or have declined standard therapy as follows:\n\n1. Cutaneous melanoma\n2. Prostate cancer\n3. Pancreatic cancer\n\nPhase II - CLL cohort\n\n1. Adult (male or female) aged ≥18 years.\n2. Signed informed consent prior to any study-specific procedures.\n3. Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures.\n4. Subjects with confirmed diagnosis of per iwCLL 2008.\n5. Documented disease progression that meets at least one of the iwCLL criteria for requiring treatment.\n6. Measurable disease defined by either absolute lymphocyte count (ALC ≥ 5 x 109\u002FL) or nodal lesion by computed tomography (CT).\n7. Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale ≤ 2.\n8. Have an estimated life expectancy of ≥16 weeks.\n9. Have adequate organ function including:\n\n   a. Adequate hematologic function in the absence of transfusions (within 6 weeks prior to first dose of study medication) and independent of growth factor support for at least 7 days with the exception of pegylated G-CSF which requires at least 14 days, defined as:\n   * WBC ≥3.0 x 109\u002FL\n   * ANC ≥1.0 x 109\u002FL\n   * Platelets ≥50 x 109\u002FL or ≥ 25 × 109\u002FL if thrombocytopenia is related to CLL b. Hepatic:\n   * Albumin ≥30 g\u002FL\n   * Bilirubin ≤2 x ULN. Subjects with known Gilbert's Syndrome or disease-related hemolysis must have a total bilirubin ≤ 3 x ULN\n   * ALT and AST ≤2.5 x ULN. c. Renal:\n   * Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m2 d. Blood coagulation:\n   * International Normalized Ratio (INR) or activated partial prothrombin time (aPTT) \\\u003C1.5 x ULN and \\> 0.8 x LLN.\n10. Have discontinued all chemotherapy, immunotherapy, investigational therapy, biologic therapy, molecularly targeted therapy, and cancer-related hormonal therapy at least 30 days prior to study enrollment (6 weeks for mitomycin-C or nitrosoureas).\n11. Are recovered or recovering from the acute adverse effects of any chemotherapy, biologic therapy, immunotherapy, molecularly targeted therapy, cancer-related hormonal therapy, and investigational therapy (≤Grade 1 or baseline), with the exception of alopecia or Grade 2 neuropathy.\n12. The subject must also agree to pretreatment and on-treatment bone marrow aspirates.\n13. Have received at least 1, but not more than 3 prior lines of therapy according to current guidelines.\n14. Patients who have had surgery must be fully recovered in the opinion of the investigator prior to enrolling on study (but not less than 28 days for major surgery and 14 days for minor surgery).\n15. Female patients with reproductive potential must agree to use 2 forms of highly effective contraception during the study and for at least 3 months following the last dose of IMP. Sexually active male patients must use a barrier method of contraception (condom) during the study and for at least 3 months following the last dose of IMP.\n16. Females with child-bearing potential must have had a negative pregnancy test result ≤28 days prior to the first dose of IMP, as well as ≤1 day prior to the first dose of IMP.\n17. Patients must be, in the judgment of the investigator, appropriate candidates for experimental therapy, and no standard therapy would confer clinical benefit to the patients.\n\nExclusion Criteria:\n\n1. Have another tumor of another location except basal cell carcinoma.\n2. Have a history of organ transplant (e.g., heart, lungs, liver, bone marrow, or kidney).\n3. Females who are pregnant or breastfeeding.\n4. Have symptomatic human immunodeficiency virus (HIV) infection, known HIV positive test results or have chronic active hepatitis B or C (screening is not required).\n5. Positive COVID-19 test or signs of coronavirus infections.\n6. Have clinically significant cardiac disease including any of the following:\n\n   * A history of congenital long QT syndrome, symptomatic bradycardia, ventricular arrhythmia, uncontrolled atrial fibrillation, second- or third-degree heart block, or other conduction abnormality that in the opinion of the investigator would preclude safe participation in this study.\n   * Congestive heart failure (New York Heart Association Class ≥3).\n   * Unstable angina pectoris, acute myocardial infarction, or stroke ≤12 months prior to enrollment.\n   * QTcF prolongation \\>450 msec.\n7. Currently taking medication known to prolong the QT interval or induce TdP, which cannot be discontinued or substituted.\n8. Uncontrolled type 1 or 2 diabetes with high risk of hypoglycemia.\n9. Are a family member of the investigator or staff of the study site.\n10. Are currently enrolled in another interventional clinical study of an investigational therapy.\n11. Hypersensitivity to any components of KLS-1. Additional exclusion criterion for patients enrolled in Phase II to CLL cohort\n12. History of Richter's transformation or prolymphocytic leukemia.",{"count":299,"type":21},[77,78],"The goal of this clinical trial is to test the safety and preliminary efficacy of a new drug, KLS-1, in adults with different types of solid tumors and chronic lymphocytic leukemia (CLL). The main questions it aims to answer are:\n\n* To define Dose Limiting Toxicities (DLT) and maximum tolerated dose (MTD) of KLS-1\n* To select the recommended Phase II Dose (P2D) of KLS-1\n* To determine the single dose and multiple dose PK profile following IV administration of KLS-1\n* What is the safest and most effective dose of KLS-1?\n* Does KLS-1 show anti-tumor activity in patients?\n* To evaluate preliminary efficacy of KLS-1 in up to 4 cohorts of locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer), or CLL.\n* To evaluate 12-months progression-free survival (PFS) and duration of response (DOR) follow-up after the last dose of KLS-1\n\nParticipants will:\n\n* Receive KLS-1 through intravenous (IV) infusions in 21-day cycles.\n* Be monitored for side effects and improvements in their malignancy. Investigators will compare different doses of KLS-1 in the initial phase to find the best dose for Phase II. Once the P2D is defined, it will be tested in a larger group to see its effects on locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer) and CLL.",[25,330],"Solid Tumor, Adult",[332,333,334,25,335,336,337,338,339,340,341,342],"malignant melanoma","prostate cancer","pancreatic cancer","chronic lymphocytic leukemia","Zn","Zinc","KLS-1","Malignant Neoplasms","Neoplasms","Metastatic Tumors","Zinc Aspartate","2024-09-28",{"date":345,"type":30},"2024-10-01",{"date":347,"type":30},"2024-05-15",{"date":349,"type":21},"2026-10-31",{"name":351,"class":65},"Vector Vitale LLC",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":363,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":4},"100558913","the-real-world-study-of-btk-inhibitor-in-the-treatment-of-chronic-lymphocytic-leukemia-in-china-100558913","NCT06557304","The Real World Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China","This is a Multicenter, Retrospective Real-world Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China","Inclusion Criteria:\n\n1. Patients aged ≥18 years old\n2. Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL \\[International Workshop on Chronic Lymphocytic Leukemia\\] criteria)；\n3. Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on BTK inhibitor;\n4. Prior or current use of BTK inhibitor for ≥3 months\n5. At least one follow-up was recorded during BTK inhibitor treatment",{"count":360,"type":21},1000,"This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China",[25],"NOT_YET_RECRUITING","2024-08-19",{"date":366,"type":30},"2024-08-21",{"date":368,"type":21},"2024-09-01",{"date":370,"type":21},"2027-12-30",{"name":372,"class":37},"Peking University People's Hospital",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":361,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":361,"conditions":381,"keywords":4,"overallStatus":363,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":38},"100553676","the-real-world-study-of-zanubrutinib-in-the-treatment-of-chronic-lymphocytic-leukemia-in-china-100553676","NCT06489184","The Real World Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China","Inclusion Criteria:\n\n* 1\\. Patients aged ≥18 years old\n* 2\\. Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL \\[International Workshop on Chronic Lymphocytic Leukemia\\] criteria)；\n* 3\\. Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on Zanubrutinib;\n* 4.Prior or current use of Zanubrutinib for ≥3 months\n* 5.At least one follow-up was recorded during Zanubrutinib treatment\n\nExclusion Criteria:\n\n\\-",{"count":380,"type":21},490,[25],"2024-06-28",{"date":384,"type":30},"2024-07-05",{"date":386,"type":21},"2024-08-01",{"date":388,"type":21},"2025-12-30",{"name":372,"class":37},{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":16,"minAge":397,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":49,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":38},"100506045","phase-1-allogeneic-carcik-cd19-in-adultspediatric-b-cell-nhl-or-chronic-lymphocytic-leukemia-100506045","NCT05869279","Allogeneic CARCIK-CD19 in Adults\u002FPediatric B-cell NHL or Chronic Lymphocytic Leukemia","Phase I\u002FII Trial to Determine the in Vivo Engraftment, Safety and Clinical Activity of Allogeneic CIK Cells Transduced With a Transposon CD19-chimeric Antigen Receptor (CARCIK-CD19) Gene in Adult and Pediatric Patients With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\ncriteria apply:\n\n1. Able and willing to provide written informed consent and to comply with the study protocol according to International Conference on Harmonization (ICH) and local regulations.\n2. Ineligibility to commercially available CAR-T cells\n3. Age limits: children (1-17 years old) and adults (≥18 years old)\n4. Availability of an at least haploidentical (i.e. 4\u002F8 HLA matched by allele typing) familial donor willing to and eligible for blood donation\n5. Histologically-confirmed mature B-cell neoplasia (NHL), according to according to WHO 2021 classification:\n\n   • Eligible histologies include: indolent \\[follicular lymphoma (FL) or marginal zone lymphoma (MZL) nodal; extra-nodal; or splenic\\] or aggressive \\[diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBL), high-grade B cell lymphoma with MYC and BCL2 rearrangements (double-hit lymphoma), mantle cell lymphoma (MCL), including transformed B-cell NHL\\], CLL or lymphocytic lymphoma (LL). high-grade B cell lymphoma (HGBCL) NOS. Additional histologies including Burkitt lymphoma and Richter syndrome will be considered upon review with Sponsor.\n6. Relapsed after or refractory to at least two prior lines of treatment, and no available treatment options that are expected to prolong survival (e.g. chemotherapy or high-dose chemotherapy\u002Fstem cell transplantation, commercially available CART cell therapy or other standard treatment) or patients refusing such treatments\n7. At least one measurable target lesion, measurable as defined by Lugano 2014 classification (nodal: \\> 1.5 cm longest transverse diameter; extra-nodal: \\> 1 cm longest transverse diameter) by computerized tomography (CT) scan or presence of assessable disease (i.e. bone marrow or spleen)\n8. Eastern Cooperative Oncology Group (ECOG) performance status equal to 2 or less for subject ≥ 16 years of age, or Lansky \\>50 for subjects \\\u003C 16 years of age\n9. Adequate cardiac and pulmonary function: ejection fraction (EF) by echo or MUGA \\>40% and radial artery (RA) oxygen saturation \\>92%.\n10. Life expectancy (in the opinion of the Investigator) of \\> 12 weeks\n11. Adequate liver function:\n\n    * Total bilirubin ≤ 2.0x ULN (≤ 3x ULN in patients with Gilbert's syndrome or documented liver involvement)\n    * AST (aspartate aminotransferase) \u002FALT (alanine aminotransferase) 3x ULN or 5x for patients with evidence of liver involvement with lymphoma\n12. Adequate bone marrow function to receive lymphodepleting chemotherapy at investigator judgment.\n13. Adequate renal function: creatinine ≤1.5x ULN or creatinine clearance (CrCl) calculated by Cockcroft-Gault formula of ≥50 mL\u002Fmin for adult patients in whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function. For children, CrCl will be calculated by local institutional standard.\n14. Females of childbearing potential (FCBP) subjects must:\n\n    * Have a negative pregnancy test as verified by the local investigator\n    * Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption from screening until at least 12 months following CARCIK-CD19 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests.\n    * Contraception methods must include one highly effective method including: surgical female sterilization, use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%)\n    * Agree to abstain from breastfeeding during study participation and for at least 12 months following CARCIK-CD19 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests.\n15. Male subjects must:\n\n    * Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for 12 months after following CARCIK-CD19 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests.\n\nExclusion Criteria:\n\n1. Patients with clinically significant active viral, bacterial or fungal infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 2 weeks prior to CARCIK-CD19 infusion.\n2. Patients with an active infection with Hepatitis B. However, patients with a controlled (treated) hepatitis will be allowed if the all the following criteria are met:\n\n   * Anti-viral therapy for hepatitis B virus (HBV) must be given for at least 1 month prior to time of informed consent;\n   * HBV viral load must be \\\u003C2000 IU\u002FmL (104 copies\u002FmL) prior to time of informed consent; and\n   * those on active HBV therapy with viral load \\\u003C2000 IU\u002FmL (104 copies\u002FmL) should stay on the same anti-viral therapy throughout study treatment\n3. Patients with an active hepatitis C virus (HCV) infection. However, patients with successfully treated chronic HCV infection will be allowed if they show a sustained virologic response at 12 weeks (SVR12) or 24 weeks (SVR24), and if there is a 4-week period between achieving sustained viral response (SVR12 or SVR24) and time of informed consent.\n4. Patients with a positive serologic test or a positive molecular PCR test for human immunodeficiency virus (HIV) are eligible if asymptomatic, well controlled by the HAART therapy and no medically significant active infection is present\n5. Rapidly progressive disease that in the estimation of the investigator and sponsor could affect compliance with the protocol or interpretation of results\n6. Active CNS lymphoma\n7. Major surgery or significant traumatic injury 28 days prior to CARCIK-CD19 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment\n8. Patients with another active invasive malignancy with a life expectancy of less than 3 years\n9. Significant cardiovascular disease (such as New York Heart Association (NYHA) Class II cardiac disease, congestive heart failure, myocardial infarction or cerebrovascular accident within 30 days prior to CARCIK-CD19 infusion, unstable arrhythmias, or unstable angina)\n10. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders (bronchospasm, obstructive pulmonary disease) and known autoimmune diseases\n11. Treatment with any other standard anti-cancer radiotherapy \u002F chemotherapy including investigational therapy (defined as treatment for which there is currently no regulatory authority approved indication) within 2 weeks prior to CARCIK-CD19 infusion\n12. Allogeneic or autologous Stem Cell Transplantation within 3 months prior to CARCIK-CD19 infusion, or Donor Lymphocytes (DLI)\n13. Active GvHD Grades II-IV or extensive chronic Graft-versus-Host Disease (for patients who had previously been allotransplanted)\n14. Prior treatment with CART cell therapy within 30 days before first study treatment administration (lymphodepletion)\n15. Toxicities from prior anti-cancer therapy including immunotherapy that did not resolve to ≤ Grade 1 with the exception of alopecia, endocrinopathy managed with replacement therapy and stable vitiligo.\n16. Ongoing corticosteroid use 25 mg\u002Fday (\\> or 0.3 mg\u002Fkg for children) of prednisone or equivalent within 1 weeks prior to CARCIK-CD19 infusion\n17. Administration of a live, attenuated vaccine within 4 weeks prior to CARCIK-CD19 infusion","1 Year",{"count":399,"type":21},29,[77,78],"This is a single arm, open-label, multi-center, phase I\u002FII study to determine the engraftment, safety and clinical activity of allogeneic CARCIK-CD19 cells in adult and pediatric patients with relapsed\u002Frefractory mature B-cell neoplasia expected to express CD19 i.e. B-cell NHL and CLL.\n\nCARCIK-CD19 will be produced from the peripheral blood of an at least haploidentical familial donor.",[403,25],"B-cell NHL","2024-05-02",{"date":406,"type":30},"2024-05-03",{"date":408,"type":30},"2023-12-01",{"date":410,"type":21},"2027-09-01",{"name":412,"class":37},"Fondazione Matilde Tettamanti Menotti De Marchi Onlus",{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":421,"conditions":422,"keywords":426,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":439},"100458186","venetoclax-resistance-landscape-in-chronic-lymphocytic-leukemia-100458186","NCT05246345","Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia","RAVEN","Inclusion Criteria:\n\n* Age greater than or equal to 18 years old;\n* chronic lymphocytic leukemia diagnosis according to iwCLL criteria;\n* refractory and\u002For relapsed disease during or after venetoclax treatment;\n* tumor samples available.\n* Relapse might be progressive chronic lymphocytic leukemia or transformation into Richter syndrome.\n* Patients must be able to express their opposition to be enrolled in this study, if need be.\n* Patients must be affiliated at the French Social Security system\n\nExclusion Criteria:\n\nPatients of their legal guardians refusing to participate\n\n\\-",{"count":273,"type":21},"The purpose of this study is to collect medical informations and samples from refractory and\u002For relapsed chronic lymphocytic leukemia during or after venetoclax treatment, in order to evaluate the frequency of resistance mechanisms.",[54,25,423,424,425],"Progressive Chronic Lymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","Relapsed Chronic Lymphocytic Leukemia",[427,428,429],"Venetoclax","Venetoclax resistance","Resistance mechanism","2024-01-08",{"date":432,"type":30},"2024-01-09",{"date":434,"type":30},"2022-03-07",{"date":436,"type":21},"2027-03",{"name":438,"class":37},"University Hospital, Clermont-Ferrand",14,{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":49,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":460},"100352427","phase-2-acalabrutinib-and-venetoclax-treatment-of-newly-diagnosed-patients-with-cll-at-high-risk-of-infection-or-early-treatment-100352427","NCT03868722","Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment","Short-term Combined Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection and\u002For Early Treatment, Who do Not Fulfil IWCLL Treatment Criteria.","Inclusion Criteria:\n\n1. CLL diagnosed according to IWCLL criteria within one year prior to randomization\n2. High risk of infection and\u002For progressive treatment within 2 years according to CLL-TIM\n3. IWCLL treatment indication not fulfilled\n4. Life expectancy \\> 2 years\n5. Age at least 18 years\n6. Ability and willingness to provide written informed consent and adhere to study procedures and treatment\n7. Adequate bone marrow function as indicated by platelets above 100 x 10E9, hemoglobin above 10 g\u002FdL and neutrophils above 1 x 10E9\n8. Creatinine clearance above 30 mL\u002Fmin directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault\n9. 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 or to Gilbert's Syndrome.\n10. Negative serological 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), negative testing for hepatitis C RNA within 6 weeks prior to registration.\n11. Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0-2.\n12. Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 2 days after the last dose of investigational drugs.\n13. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.\n14. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information\n\nExclusion Criteria:\n\n1. Prior CLL treatment (including monoclonal antibodies, chemotherapy, small molecules)\n2. Transformation of CLL (Richter's transformation)\n3. Previous autoimmune disease as AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura) treated with immune suppression or uncontrolled AIHA or ITP\n4. History of PML\n5. Uncontrolled or active infection\n6. Malignancies other than CLL requiring systemic therapies (except anti-hormonal therapies) or considered to impact survival\n7. Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors\u002Finducers or anticoagulant therapy with vitamin K antagonists\n8. History of bleeding disorders or current platelet inhibitors or anticoagulant therapy\n9. History of clinically significant cardiovascular disease such as arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \\> 480 msec at screening.\n10. History of stroke or intracranial hemorrhage within 6 months prior to registration.\n11. Use of investigational agents which might interfere with the study drug within 28 days prior to registration.\n12. Vaccination with live vaccines 28 days prior to registration.\n13. Major surgery less than 30 days before start of treatment.\n14. Known hypersensitivity to any active substance or to any of the excipients of one of the drugs used in the trial.\n15. Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment; further pregnancy testing will be performed regularly).\n16. Fertile men or women of childbearing potential unless: surgically sterile or ≥ 2 years after the onset of menopause or willing to use two methods of reliable contraception including one highly effective contraceptive method (Pearl Index \\\u003C1) and one additional effective (barrier) method during study treatment and for 18 months after the end of study treatment.\n17. Legal incapacity.\n18. Persons who are in dependence to the sponsor or an investigator\n19. Persons not considered fit for the trial by the investigator\n20. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.\n21. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.\n22. Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor\u002Finducer.\n23. Prothrombin time\u002FINR or aPTT (in the absence of Lupus anticoagulant) \\> 2x ULN.\n24. Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.\n25. Major surgical procedure within 7 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug.\n26. Breastfeeding or pregnant.",{"count":448,"type":21},212,[78,51],"Many patients with CLL have a weakened immune system due to their disease. It increases their risk of developing serious, treatment-requiring infections such as blood poisoning or pneumonia, which in the worst case may end with fatal outcomes.\n\nSerious infections due to CLL are responsible for one third of all deaths among CLL patients. PreVent-ACaLL study will investigate whether a combination of two known types of cancer drugs can reduce the risk of infection and thus mortality when given preventively to newly diagnosed CLL patients.\n\nA newly developed register-based computer model can predict which patients are at high risk in order to develop infections as a result of their CLL. A preventive treatment might be initiated before patients need chemotherapy. In this way, the cancer disease might be \"reset\" so that the immune system, which is inhibited by CLL, is restored and the risk of fatal infections is minimized.",[25],{"date":453,"type":30},"2023-12-04",{"date":455,"type":30},"2019-10-11",{"date":457,"type":21},"2030-07-31",{"name":459,"class":37},"Rigshospitalet, Denmark",7]