[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-t-cell-lymphomamycosis-fungoides\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-t-cell-lymphomamycosis-fungoides":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,74,101],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100648097","phase-2-efficacy-and-safety-of-brentuximab-vedotin-combined-with-lisaftoclax-in-cd30-cutaneous-t-cell-lymphoma-ctcl-100648097",false,"NCT07717580","Efficacy and Safety of Brentuximab Vedotin Combined With Lisaftoclax in CD30+ Cutaneous T-cell Lymphoma (CTCL)","A Phase II, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Brentuximab Vedotin Combined With Lisaftoclax in Patients With CD30-positive Cutaneous T-cell Lymphoma (CTCL)","BV-LISA-CTCL","Inclusion Criteria:\n\n1. Age greater than or equal to 18 years.\n2. Confirmed diagnosis of mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL).\n3. CD30 positive confirmed by skin biopsy (at least 2 lesion biopsies for MF patients, and at least 1 lesion biopsy for pcALCL patients). CD30 positivity is defined as greater than or equal to 10% of target lymphocytes showing CD30 membrane, cytoplasmic, and\u002For Golgi-like staining, with a staining intensity higher than the background staining of the corresponding negative control.\n4. Prior treatment requirements:\n\n   * pcALCL: Must have received ≥ 1 prior systemic therapy or radiotherapy.\n   * MF: Must have received ≥ 1 prior systemic therapy.\n   * Note: Patients must be chemotherapy-naïve.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2.\n6. Adequate hepatic, renal, and hematopoietic function.\n7. Females of childbearing potential must be willing to use highly effective methods of contraception during the study and for 6 months after the last dose of study drug; or must be postmenopausal for greater than or equal to 1 year, or surgically sterile.\n8. Males, even if surgically sterilized (i.e., post-vasectomy), must agree to use highly effective methods of contraception during the study and for 6 months after the last dose of study drug.\n9. No cognitive or communication barriers; capable of understanding and willing to sign a written informed consent form (ICF), and willing to comply with the study visits and procedures.\n10. Good venous access for required blood sampling.\n\nExclusion Criteria:\n\n1. Concomitant diagnosis of systemic anaplastic large cell lymphoma (sALCL), other non-Hodgkin lymphomas (except lymphomatoid papulosis), Sézary syndrome, or stage B2 disease.\n2. Active central nervous system (CNS) involvement of lymphoma.\n3. Prior treatment with chemotherapy, allogeneic or autologous stem cell transplantation.\n4. Prior treatment with brentuximab vedotin or any B-cell lymphoma 2 (BCL-2) inhibitors.\n5. Receipt of corticosteroids for cutaneous T-cell lymphoma (CTCL) or skin-directed therapies within 3 weeks prior to the first dose of study drug.\n6. Receipt of antibody-directed therapy, immunoglobulin therapy, or other monoclonal antibodies within 12 weeks prior to the first dose of study drug.\n7. History of other primary malignancies not in complete remission for greater than or equal to 3 years (exceptions: adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, squamous intraepithelial lesions, or localized prostate cancer with no evidence of recurrence based on prostate-specific antigen (PSA) levels).\n8. Presence of severe organ dysfunction or history of major organ diseases, including:\n\n   * Cardiac: Left ventricular ejection fraction (LVEF) less than 50%; unstable angina; acute myocardial infarction within the past 6 months; New York Heart Association (NYHA) class III-IV congestive heart failure; clinically significant arrhythmias.\n   * Renal: Creatinine clearance ≤ 50 mL\u002Fmin.\n   * Hepatic: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \\> 3 × Upper Limit of Normal (ULN), or Total Bilirubin \\> 1.5 × ULN.\n9. Active liver or biliary disease (exceptions: Gilbert's syndrome, asymptomatic gallstones, liver involvement by lymphoma, or stable chronic liver disease assessed by the investigator).\n10. History of severe cerebrovascular disease within the past 6 months, or current presence of symptomatic\u002Fsequelae cerebrovascular events.\n11. History of pancreatitis or high-risk factors for pancreatitis.\n12. Uncontrolled systemic bacterial, fungal, viral, or other severe infections.\n13. Positive test for Human Immunodeficiency Virus (HIV) or Hepatitis B virus (positive HBsAg or HBcAb).\n14. Known hypersensitivity to recombinant proteins, murine proteins, or any excipients of the study drugs.\n15. Female patients who are pregnant, lactating, or planning to become pregnant within 6 months.\n16. Presence of severe concurrent medical\u002Fpsychiatric conditions that may compromise patient safety or compliance, or interfere with informed consent, study participation, or interpretation of results.\n17. Any other conditions that, in the opinion of the investigator, make the patient unsuitable for study participation.","ALL","18 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, single-center, open-label, randomized, controlled phase II clinical trial. The main purpose of this study is to evaluate the efficacy and safety of combining brentuximab vedotin (an anti-CD30 antibody-drug conjugate, ADC) with lisaftoclax (APG-2575, a novel B-cell lymphoma 2 (BCL-2) inhibitor) in patients with CD30-positive cutaneous T-cell lymphoma (CTCL), specifically including mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL).\n\nPrevious studies suggest that the overexpression of the anti-apoptotic protein BCL-2 may contribute to brentuximab vedotin resistance in CTCL. Researchers hypothesize that adding a highly selective BCL-2 inhibitor (lisaftoclax) can reverse this drug resistance, enhance tumor cell apoptosis, and improve clinical outcomes.\n\nIn this study, approximately 46 eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment arms:\n\nMonotherapy arm (control): Patients will receive brentuximab vedotin intravenously at a dose of 1.8 mg\u002Fkg every 3 weeks for a total of 16 cycles.\n\nCombination arm (experimental): Patients will receive the same brentuximab vedotin regimen. Additionally, starting from the 6th cycle, patients will receive oral lisaftoclax. To mitigate the risk of tumor lysis syndrome (TLS), a daily dose ramp-up will be implemented in the first cycle of lisaftoclax. Subsequently, lisaftoclax will be administered at a targeted dose of 600 mg daily on days 1 to 10 of each 21-day cycle, for a total of 9 combination cycles.\n\nThe primary endpoint of the study is the objective response rate (ORR) evaluated at the end of the 16 cycles. Secondary endpoints include the improvement of skin lesions (evaluated by modified severity-weighted assessment tool (mSWAT) score), pruritus relief (visual analog scale (VAS) score), and the incidence of adverse events (AEs). Independent, blinded assessors will be utilized to evaluate the clinical responses to reduce bias.",[27,28],"Cutaneous T-Cell Lymphoma\u002FMycosis Fungoides","Primary Cutaneous Anaplastic Large Cell Lymphoma","NOT_YET_RECRUITING","2026-07-21",{"date":32,"type":33},"2026-07-23","ACTUAL",{"date":35,"type":21},"2026-07-31",{"date":37,"type":21},"2028-12-30",{"name":39,"class":40},"Peking University First Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100561338","systemic-therapies-in-the-treatment-of-cutaneous-t-cell-lymphoma-100561338","NCT06588868","Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma","Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study","FIL_CTCL","Inclusion Criteria:\n\n* Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.\n* Age ≥18 years.\n* Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023.\n* Availability of complete medical records in order to provide protocol required variables\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients not meeting the above-mentioned inclusion criteria.\n* Refuse to sign a written informed consent.",{"count":51,"type":21},400,"OBSERVATIONAL","The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.",[55,27,56],"Cutaneous T Cell Lymphoma","Cutaneous T-Cell Lymphoma\u002FSezary Syndrome",[55,58,59,60,61,62],"Mycosis Fungoides","Sézary Syndrome","Retrospective","Systemic therapy","Real world","RECRUITING","2025-12-01",{"date":66,"type":33},"2025-12-02",{"date":68,"type":33},"2025-02-27",{"date":70,"type":21},"2026-07",{"name":72,"class":40},"Fondazione Italiana Linfomi - ETS",18,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100596530","long-term-assessment-of-chlormethine-gel-in-mycosis-fungoides-100596530","NCT07046663","Long-term Assessment of Chlormethine Gel in Mycosis Fungoides","Long-term Assessment of Chlormethine Gel in Mycosis Fungoides: A Multicenter Retrospective Cohort Study","FIL_CLOR-CTCL","Inclusion Criteria:\n\n* Patients age ≥ 18\n* Histologically confirmed diagnosis of MF based on WHO Classification of Tumours, Haematolymphoid Tumours, 5th edition\n* Patients who are capable of understanding and willing, and able to read and write in Italian\n* Patients who have signed informed consent form\n* Patients who started treatment with chlormethine gel, from September 1, 2019 to September 30, 2024.\n* Patients must have a minimum follow-up period of 6 months following the initiation of chlormethine treatment.\n* Availability of complete medical records in order to provide protocol required variables.\n\nExclusion Criteria:\n\n* Patients for whom retrospective data or information on the type of therapy, duration, and clinical outcomes are not available in the center's medical records.\n* Refuse to sign a written informed consent.\n* Patients not meeting the above-mentioned inclusion criteria",true,{"count":84,"type":21},190,"The study aims to provide comprehensive insights into the long-term therapeutic outcomes, potential adverse effects, and overall patient experience with chlormethine gel, thereby informing clinical practice and guiding future treatment strategies for mycosis fungoides.",[27],[88,89,90,91],"mycosis fungoides","cutaneous T-cell lymphoma","chlormethine gel","long term assessment","2025-07-01",{"date":94,"type":33},"2025-07-04",{"date":96,"type":21},"2025-09",{"date":98,"type":21},"2026-06",{"name":72,"class":40},20,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":111,"studyType":52,"phases":4,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100549641","a-study-of-molecular-subtyping-based-therapeutic-strategies-for-cutaneous-t-cell-lymphoma-100549641","NCT06436677","A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma","AMITY","Inclusion Criteria:\n\n* Signed informed consent;\n* Patients with CTCL who do not respond well to targeted skin therapy (topical corticosteroids, nitrogen mustard, or phototherapy) in the early stage (stage I-IIA) and advanced stage (stage IIB-IV);\n* Age 18-75 years;\n* Expected survival time greater than 3 months (follow-up for the historical control group was greater than 3 months);\n\nExclusion Criteria:\n\n* Received other anti-tumor therapy other than skin-targeted therapy (phototherapy, topical hormones or nitrogen mustard) within the past 1 month prior to enrollment;\n* Patients with 2 or more types of primary cutaneous T-cell lymphoma at the same time;\n* Combined with other malignant tumors, still receiving anti-tumor therapy;\n* Has any other active disease that may increase the risk of protocol therapy or impair the patient\\'s ability to receive protocol therapy, including but not limited to:\n\n  * Comorbid epilepsy;\n  * Comorbid autoimmune diseases;\n  * Combined with hepatic decompensation;\n  * Patients with renal insufficiency and creatinine clearance \\< 50ml\u002Fmin;\n* Have an uncontrollable medical condition, including but not limited to:\n\n  * Ongoing or active infection;\n  * Clinically significant healing or non-healing wounds;\n  * Symptomatic congestive heart failure, unstable angina, clinically significant arrhythmias;\n  * Significant lung disease (e.g., shortness of breath at rest or light activity, or need for supplemental oxygen for any reason);\n  * Diseases\u002Fconditions that affect study compliance, such as infectious diseases or psychiatric illnesses\u002Fsocial situations, that are uncontrollable;\n* Pregnant (or intending to become pregnant within 2 years) or lactating females;\n* Concomitant participation in interventional clinical trials of other clinical trial drugs, except for questionnaire surveys or observational studies;\n* Any situation in which the programme is not in compliance;\n* Other conditions that in the opinion of the investigator are not suitable for participation in this study.","75 Years",{"count":110,"type":21},100,"2 Years","Cutaneous T-cell lymphoma (CTCL) is a group of diseases resulting from clonal hyperplasia of memory T cells in the skin. The increasing incidence and high treatment costs have posed significant challenges to public health and the economy. Current treatment guidelines only provide partial control, leading to varying remission times and recurrence rates. This study aims to use molecular subtyping and immunohistochemistry to guide treatment selection for CTCL patients, aiming to prolong clinical benefit, improve treatment safety, and reduce economic burden.",[27,55],[89,88,115],"Sezary syndrome","2024-05-24",{"date":118,"type":33},"2024-05-31",{"date":120,"type":33},"2024-05-09",{"date":122,"type":21},"2030-12-31",{"name":39,"class":40},3]