[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-cutaneous-anaplastic-large-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-cutaneous-anaplastic-large-cell-lymphoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":85,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100514411","a-registry-for-people-with-t-cell-lymphoma-100514411","NCT05978141","A Registry for People With T-cell Lymphoma","The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens","Inclusion Criteria:\n\n* Written informed consent\n* Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy.\n* Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines):\n\n  * T-cell prolymphocytic leukemia\n  * T-cell large granular lymphocytic leukemia\n  * Chronic lymphoproliferative disorder of NK cells\n  * Aggressive NK-cell leukemia\n  * Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood\n  * Chronic active EBV infection of T- and NK-cell type, systemic form\n  * Hydroa vacciniforme-like lymphoproliferative disorder\n  * Adult T-cell leukemia\u002Flymphoma\n  * Extranodal NK\u002FT-cell lymphoma, nasal type\n  * Enteropathy-associated T-cell lymphoma\n  * Monomorphic epitheliotropic intestinal T-cell lymphoma\n  * Intestinal T-cell lymphoma, not otherwise specified (NOS)\n  * Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract\n  * Hepatosplenic T-cell lymphoma\n  * Subcutaneous panniculitis-like T-cell lymphoma\n  * Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy)\n  * Sézary syndrome\n  * Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy)\n  * Primary cutaneous Gamma-Delta T-cell lymphoma\n  * Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma\n  * Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy)\n  * Peripheral T-cell lymphoma, not otherwise specified\n  * Angioimmunoblastic T-cell lymphoma\n  * Follicular T-cell lymphoma\n  * Nodal peripheral T-cell lymphoma with TFH phenotype\n  * Anaplastic large cell lymphoma, ALK-positive\n  * Anaplastic large cell lymphoma, ALK-negative\n  * Breast-implant associated anaplastic large cell lymphoma.\n* NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy.\n\nExclusion Criteria:\n\n* Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy.\n* Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.",{"count":50,"type":21},1000,"10 Years","OBSERVATIONAL","The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.",[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,28,75,76,77,78,79,80,81,82,83,84],"T-cell Lymphoma","NK-Cell Lymphoma","T-cell Prolymphocytic Leukemia","T-cell Large Granular Lymphocytic Leukemia","Chronic Lymphoproliferative Disorder of NK Cells","Aggressive NK-cell Leukemia","Systemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder)","Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood","Chronic Active EBV Infection of T-and NK-Cell Type, Systemic Form","Hydroa Vacciniforme-Like Lymphoproliferative Disorder","Adult T-cell Leukemia\u002FLymphoma","Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Enteropathy-associated T-cell Lymphoma","Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma","Intestinal T-Cell Lymphoma, Not Otherwise Specified","Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","Hepatosplenic T-cell Lymphoma","Subcutaneous Panniculitis-Like T-Cell Lymphoma","Mycosis Fungoides","Sezary Syndrome","Primary Cutaneous T-cell Lymphoma","Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma","Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Angioimmunoblastic T-cell Lymphoma","Follicular T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-negative","Breast Implant-Associated Anaplastic Large Cell Lymphoma",[86,87,88,89,90],"23-190","T-cell lymphoma","Memorial Sloan Kettering Cancer Center","T-cell Lymphoma Master Repository","TCLMR","RECRUITING","2026-05-18",{"date":94,"type":33},"2026-05-20",{"date":96,"type":33},"2023-07-27",{"date":98,"type":21},"2030-07-27",{"name":88,"class":40},26]