[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-t-cell-lymphoma-ptcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-t-cell-lymphoma-ptcl":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,83],{"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":26,"conditions":27,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100526622","phase-1-azd3470-as-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-haematologic-malignancies-100526622",false,"NCT06137144","AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.","A Modular Phase I\u002FII, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, and Efficacy of AZD3470, a PRMT5 Inhibitor, as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies","PRIMAVERA","Inclusion Criteria:\n\nCore Inclusion criteria:\n\n1. Adequate adult (ECOG) or adolescent (Karnofsy or Lanksy) Performance Score assessments\n2. Adequate organ and bone marrow function.\n\nModule 1 Cohort 1:\n\n1. Age:\n\n   1. Part A (dose escalation): aged ≥ 18 years at the time of signing the informed consent.\n   2. Part B (optimization): aged ≥ 12 years of age. Adolescent participants must weigh ≥ 40 kg.\n2. Histologically confirmed diagnosis of cHL based on WHO criteria\n3. Previous treatment with at least 2 prior lines of therapy for the treatment of cHL (including at least 2 cycles of BV and anti-PD1) and have documented r\u002Fr active disease requiring treatment.\n4. Participants must provide FFPE baseline tumour tissue.\n5. At least 1 radiographically measurable, and\u002For FDG-avid lymphoma lesion ( \\>1.5 cm for nodal lesion and \\>1 cm for extranodal lesion).\n\nModule 1 Cohort 2:\n\n1. Participants must be at least 50 years of age or older at study entry.\n2. Histologically confirmed diagnosis of cHL based on WHO criteria\n3. Ann Arbor stages III or IV.\n4. Participant must have previously received at least 4 cycles of SoC combination therapy with A-AVD, N-AVD, AVD, or ABVD (based on regional SOC, per investigator) as finite first-line induction therapy, and achieved at least a PR post-induction therapy.\n5. Participants must provide FFPE baseline tumour tissue.\n\nModule 1 Cohort 3:\n\n1. Participants must be aged ≥ 18 years at the time of signing the informed consent.\n2. Histologically confirmed diagnosis of PTCL NOS, systemic ALCL, or AITL based on WHO criteria.\n3. Participants must have received at least 1 prior line of therapy for the treatment of PTCL and have exhausted all available therapies with demonstrated clinical benefit. Participants with ALCL must have received prior BV treatment.\n4. Participants must provide FFPE baseline tumour tissue\n\n   a. Ability to provide an on-treatment biopsy (if the tumour is suitable for biopsy).\n5. At least 1 radiographically measurable, and\u002For FDG-avid lymphoma lesions (\\> 1.5 cm for nodal lesion and \\>1 cm for extranodal lesion).\n\nModule 2 Cohort 1:\n\n1. Participants must be aged ≥ 18 years at the time of signing the informed consent.\n2. Histologically confirmed diagnosis of cHL based on WHO criteria\n3. At least 1 radiographically measurable, and\u002For FDG-avid lymphoma lesions (\\> 1.5 cm for nodal lesion and \\>1 cm for extranodal lesion).\n4. Participant must have received at least 1 prior line of therapy for the treatment of cHL and have documented r\u002Fr active disease requiring treatment.\n5. Participants must provide FFPE baseline tumour tissue.\n\nExclusion Criteria:\n\nCore Exclusion criteria:\n\n1. Any significant laboratory finding or any severe and uncontrolled medical condition.\n2. Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression.\n3. Serologic active HBV or HCV infection.\n4. Known to have tested positive for HIV.\n5. Active gastrointestinal disease or other condition that will interfere with oral therapy.\n6. Any of the following ECG cardiac criteria: Mean resting QTcF \\> 470 msec, clinically important abnormalities in rhythm, conduction or morphology, and\u002For any factors that increase the risk of QTc prolongation or risk of arrhythmic events.\n7. Undergone any of the following procedures within 6 months prior to first dose:\n\n   1. Coronary artery bypass graft,\n   2. Percutaneous coronary intervention or heart valve replacement or repairment,\n   3. Vascular stent implantation (venous stent is eligible),\n   4. Acute coronary syndrome \u002F myocardial infarction,\n   5. Unstable or poorly controlled angina pectoris,\n   6. Ventricular arrhythmias requiring continuous therapy,\n   7. Uncontrolled atrial fibrillation,\n   8. Haemorrhagic or thrombotic stroke (including transient ischaemic attacks) or any other CNS bleeding.\n   9. Acute venous or atrial thromboembolic event (unless considered stable or adequately treated with at least 3months of therapeutic anticoagulation).\n8. Severe valvular heart disease.\n9. Congestive heart failure Grade II to Grade IV.\n10. Prior or current cardiomyopathy.\n11. Uncontrolled hypertension.\n12. History of significant haemoptysis or haemorrhage within4 weeks of the first dose of study treatment.\n13. Unresolved toxicities of Grade \\> 1 from prior anti cancer therapy (excluding peripheral neuropathy, vitiligo, alopecia and endocrine disorders that are controlled with replacement hormone therapy, and asymptomatic laboratory abnormalities), unless immune-mediated.\n14. History of another primary malignancy.\n15. Received the following anticancer therapies: anti-lymphoma therapy (within 21 days), radiation therapy(within 28 days), allo-HSCT (within 180 days), auto-HSCT\u002Fcellular therapy (within 60 days), or MAT2A or PRMT5 inhibitor\n16. Requires ongoing immunosuppressive therapy, including systemic corticosteroids.\n\nModule 2 Cohort 1:\n\n1. History of confirmed ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment or any evidence of clinically active ILD or pneumonitis.\n2. ≥Grade 3 immune-mediated AE while receiving prior checkpoint inhibitor immunotherapy, or any unresolved ≥Grade 2 immune-mediated AE.\n3. History of immune-mediated myocarditis or pericarditis.\n4. Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n5. Active or prior documented pathologically confirmed autoimmune or inflammatory disorders\n6. Refractory to prior checkpoint inhibitor therapy (within 12 weeks of last dose)\n7. Eligible for allogeneic or autologous stem cell transplant.\n8. Received an allogeneic HSCT within 5 years of the first dose of study treatment; must not have active Graft-versus-host disease.\n9. Participants with a known hypersensitivity to pembrolizumab or any of the excipients of the product.","ALL","12 Years",{"count":20,"type":21},161,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.",[28,29,30,31,32,33,34],"Lymphoma","Non-Hodgkin Lymphoma","Hodgkin Lymphoma","Peripheral T-cell Lymphoma (PTCL)","PTCL-NOS","ALCL","AITL",[36,37,38,39,40],"Haematologic Malignancies","Hodgkin lymphoma","Peripheral T-cell lymphoma (PTCL)","Methylthioadenosine Phosphorylase (MTAP) deficient","Protein Arginine Methyltransferase 5 (PRMT5)","RECRUITING","2026-06-23",{"date":44,"type":45},"2026-06-24","ACTUAL",{"date":47,"type":45},"2024-01-23",{"date":49,"type":21},"2029-05-03",{"name":51,"class":52},"AstraZeneca","INDUSTRY",37,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100605399","early-phase-1-safety-and-efficacy-of-anti-ebv-autologous-tcr-t-cell-injection-in-relapsedrefractory-ebv-positive-lymphoma-100605399","NCT07162012","Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed\u002FRefractory EBV-Positive Lymphoma","The Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection for Treating Relapsed\u002FRefractory EBV-positive Lymphoma Patients With HLA-A11:01","Anti-EBV TCR-T","Inclusion Criteria:\n\n1. Age 18-70 years, male or female.\n2. HLA genotype at locus A is 11:01.\n3. Disease diagnosis and status:\n\n   1. Histologically or cytologically confirmed EBV-positive lymphoma (tumor tissue must be EBER-positive as confirmed by in situ hybridization \\[ISH\\] or fluorescence in situ hybridization \\[FISH\\]), with peripheral blood EBV viral load \\>10³ copies\u002FmL by quantitative real-time PCR.\n   2. Disease types include but are not limited to:\n\n      NK\u002FT-cell lymphoma (NK\u002FTCL); Peripheral T-cell lymphoma (PTCL); Other types.\n   3. Definition of relapse: appearance of new lesions at the primary site or other sites after achieving complete remission (CR).\n   4. Definition of refractory disease (meeting any of the following):\n\n   No partial remission (PR) after ≥4 cycles of standard therapy; No complete remission (CR) after ≥6 cycles of therapy; Failure to achieve CR after autologous hematopoietic stem cell transplantation; If best response is progressive disease (PD) or treatment is discontinued due to PD, no minimum cycle requirement applies.\n4. Prior treatment requirements:\n\n   a) For relapsed\u002Frefractory PTCL or NK\u002FTCL, patients must have received at least one prior line of systemic therapy. For relapsed\u002Frefractory NK\u002FTCL, patients must have received an asparaginase-containing regimen (patients with stage I\u002FII nasal NK\u002FTCL according to the CA staging system must have also received radiotherapy).\n5. Measurable disease: At least one measurable lesion according to the 2014 Lymphoma Response Evaluation Criteria:\n\n   1. Nodal lesions: longest diameter \\>15 mm on contrast-enhanced CT, MRI, or PET-CT;\n   2. Extranodal lesions: longest diameter \\>10 mm. For patients with bone-marrow-only involvement who have no measurable lesions on imaging, the presence of ≥5% lymphoma cells in bone marrow biopsy or flow cytometry can be considered an evaluable lesion.\n6. Adequate organ function, defined as:\n\n   1. Hematologic: absolute neutrophil count ≥1×10⁹\u002FL; hemoglobin ≥70 g\u002FL; platelet count ≥50×10⁹\u002FL;\n   2. Hepatic: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × the upper limit of normal (ULN), and total bilirubin (TBIL) ≤ 1.5 × ULN (except when liver function abnormalities are attributable to the underlying disease);\n   3. Renal: serum creatinine ≤1.5× ULN;\n   4. Cardiac: left ventricular ejection fraction (LVEF) ≥50%;\n   5. Coagulation: fibrinogen ≥1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤1.5× ULN; prothrombin time (PT) ≤1.5× ULN.\n7. Expected survival \\>3 months.\n8. ECOG performance status \\\u003C3.\n9. Contraception requirements:\n\n   1. No pregnancy planned during the treatment period;\n   2. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 4 months after the end of treatment.\n10. Willingness to participate in the study, ability to sign informed consent, comply with the study protocol, and availability of peripheral venous access for lymphocyte collection.\n\nExclusion Criteria:\n\nSubjects meeting any of the following conditions will not be eligible for enrollment:\n\n1. History of other malignancies, except for:\n\n   1. Basal cell carcinoma of the skin;\n   2. Squamous cell carcinoma of the skin;\n   3. Superficial bladder cancer;\n   4. Carcinoma in situ of the cervix;\n   5. Gastrointestinal mucosal carcinoma in situ;\n   6. Other malignancies considered acceptable by the investigator (must have received curative treatment with no recurrence within the past 5 years).\n2. Recent anti-tumor therapy: less than 4 weeks since last anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local therapy), or less than 2 weeks since palliative radiotherapy.\n3. Pregnant or breastfeeding women.\n4. Presence of severe medical conditions such as intracranial hypertension, impaired consciousness, respiratory failure, or disseminated intravascular coagulation (DIC).\n5. Severe organ dysfunction, including:\n\n   NYHA class IV cardiac function; Child-Pugh class C liver function; Creatinine clearance \\\u003C60 mL\u002Fmin (by Cockcroft-Gault formula); Baseline oxygen saturation \\\u003C92%.\n6. Known active infections or positive screening results for:\n\n   1. Hepatitis B virus (HBV): HBsAg positive, or HBcAb positive with HBV-DNA above the detection limit of the study center;\n   2. Hepatitis C virus (HCV): HCV antibody positive and HCV RNA ≥ upper limit of normal (ULN);\n   3. Human immunodeficiency virus (HIV) or Treponema pallidum (syphilis) antibody positive;\n   4. Active tuberculosis (TB) (must be excluded by chest X-ray, sputum test, and clinical symptoms) or history of active TB;\n   5. Severe acute or chronic infections requiring systemic treatment.\n7. Active central nervous system (CNS) disease (e.g., tumor metastasis, infection, demyelinating disease), including untreated lesions, progressive disease on imaging or symptoms requiring urgent intervention, or requiring high-dose immunosuppressive therapy for control.\n8. Receiving systemic corticosteroid therapy prior to screening and judged by the investigator to require long-term systemic corticosteroid treatment during the study (excluding inhaled or topical use); or receiving systemic corticosteroid treatment within 72 hours before cell infusion (excluding inhaled or topical use).\n9. Presence of graft-versus-host disease (GVHD), defined as grade ≥2 acute GVHD or moderate\u002Fsevere chronic GVHD, or current use of immunosuppressive therapy.\n10. History of severe allergic reactions to drugs or excipients required in this study, or history of allergy to tocilizumab.\n11. Any condition that, in the opinion of the investigator, makes the subject unsuitable for study participation.","18 Years","70 Years",{"count":65,"type":21},24,[67],"EARLY_PHASE1","This study will test whether anti-EBV autologous TCR-T cell injection is safe and effective for patients with relapsed or refractory EBV-positive lymphoma who have HLA-A11:01. Researchers will look at safety, tolerability, and the maximum tolerated dose or recommended dose for future studies.\n\nThe study will also measure how the infused TCR-T cells expand and persist in the body, changes in EBV DNA levels and T-cell subgroups in the blood, and whether the treatment shows early signs of clinical benefit. Researchers will also explore whether the treatment causes an immune response against the infused cells.",[70,31,71],"NK\u002FT-cell Lymphoma","DLBCL","2025-11-29",{"date":74,"type":45},"2025-12-02",{"date":76,"type":45},"2025-09-20",{"date":78,"type":21},"2029-09",{"name":80,"class":81},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":90,"targetDuration":92,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100590147","a-real-world-study-on-golidocitinib-based-therapeutic-regimens-for-the-treatment-of-patients-with-peripheral-t-cell-lymphoma-100590147","NCT06963632","A Real-world Study on Golidocitinib-based Therapeutic Regimens for the Treatment of Patients With Peripheral T-cell Lymphoma","JOYCE","Inclusion Criteria:\n\n1. Voluntarily sign and acknowledge understanding of the Informed Consent Form\n2. Clinically confirmed diagnosis of peripheral T-cell lymphoma\n3. Inclusion of PTCL patients who initiated a Golidocitinib-based treatment regimen within the past 3 months\n4. Compliance with clinical management and provision of disease-related historical medical information required for the study, including but not limited to medical records, treatment history, and prior\u002Fprescribed therapeutic regimens\n\nExclusion Criteria:\n\n1. Poor patient adherence\n2. Investigator-deemed ineligibility for enrollment",{"count":91,"type":21},1000,"1 Year","OBSERVATIONAL","This real-world study aims to evaluate the safety and efficacy of golidocitinib-based treatment regimens in patients with peripheral T-cell lymphoma (PTCL), without intervention in the selection of therapeutic strategies. A total of 1,000 PTCL patients are planned to be enrolled. After screening, eligible participants meeting the inclusion and exclusion criteria will be assigned to one of three predefined cohorts:\n\nCohort 1: Treatment-naïve patients with PTCL or NK\u002FT-cell lymphoma.\n\nCohort 2: Patients receiving maintenance therapy following remission after first-line induction treatment for PTCL.\n\nCohort 3: Patients with relapsed or refractory PTCL or relapsed\u002Frefractory NK\u002FT-cell lymphoma.\n\nThere is no cap on the number of participants in each cohort.",[31],"NOT_YET_RECRUITING","2025-05-06",{"date":99,"type":45},"2025-05-09",{"date":101,"type":21},"2025-04-30",{"date":103,"type":21},"2027-12-31",{"name":105,"class":81},"Ruijin Hospital","Peripheral T Cell Lymphoma (PTCL)"]