[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ptcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ptcl":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,45,75,101,124,155,178,200,220],{"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":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100651268","phase-1-a-phase-iii-study-of-fg-m131-in-trbc1-relapsedrefractory-peripheral-t-cell-lymphoma-100651268",false,"NCT07758491","A Phase I\u002FII Study of FG-M131 in TRBC1+ Relapsed\u002FRefractory Peripheral T-Cell Lymphoma","An Open-label, Multicenter Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-M131 in Patients With TRBC1-positive Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;\n* Age 18-75 years (inclusive), any gender;\n* Histologically and\u002For cytologically confirmed peripheral T-cell lymphoma or cutaneous T-cell lymphoma;\n* Relapsed or refractory lymphoma after at least one prior line of therapy；\n* Able to provide tumor tissue specimens;\n* ECOG performance status of 0 or 1;\n* Expected survival ≥3 months;\n* Have at least one measurable tumor lesion;\n* Adequate cardiac, bone marrow, liver, renal function;\n\nExclusion Criteria:\n\n* Have received a live vaccine within 3 months prior to the first dose;\n* Have received radiotherapy within 4 weeks prior to the first dose;\n* Have received other anti-tumor drug therapy within 3 weeks or within 5 half-lives of the anti-tumor drug prior to the first dose;\n* Have undergone major surgery within 4 weeks prior to the first dose;\n* Have previously received any therapy targeting the TRBC1 antigen or any antibody-drug conjugate with MMAE payload;\n* Have received autologous stem cell transplantation within 3 months prior to the first dose;\n* Have previously received allogeneic stem cell transplantation;\n* Have a history of other malignancies within 5 years prior to the first dose;\n* Have received high-dose systemic vitamin A therapy (daily dose \\>15,000 IU \\[i.e., 5,000 mcg\\]) within 3 weeks prior to the first dose of study drug;\n* Have any condition requiring systemic treatment with corticosteroids (\\>20 mg\u002Fday prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose;\n* Have received oral retinoid drugs for any indication within 3 weeks prior to the first dose;\n* Have adverse reactions from prior treatments that have not recovered to CTCAE v5.0 Grade ≤1 (excluding alopecia and anemia) prior to the first dose;\n* Presence or history of central nervous system lymphoma, leptomeningeal disease, or spinal cord compression;\n* Have a history of severe allergic reactions or are allergic to the investigational drug;\n* Have experienced a clinically significant cardiac disease within 6 months before the first dose;\n* Have uncontrolled systemic diseases assessed by the investigator, including diabetes, hypertension, pulmonary fibrosis, interstitial lung disease, etc.;\n* Known history of Hepatitis C or chronic active Hepatitis B;\n* Clinically uncontrolled diseases such as diabetes mellitus, thyroid disease, or other severe systemic diseases requiring systemic treatment;\n* Active or progressive infection requiring systemic therapy within 2 weeks prior to the first dose;\n* Known or suspected active autoimmune disease requiring systemic therapy within 2 years prior to the first dose;\n* Are pregnant or breastfeeding;","ALL","18 Years","75 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","FG-M131 for injection is an antibody-drug conjugate (ADC) targeting the T-cell receptor beta chain constant region 1 (TRBC1). TRBC1 is a subunit of the αβ T-cell receptor (TCR) complex. Targeting TRBC1 can eliminate TRBC1-positive malignant T cells while sparing TRBC2-positive normal T cells, providing a novel strategy for the treatment of T-cell malignancies.\n\nThis study is a multicenter, open-label Phase I\u002FII clinical trial in patients with TRBC1-positive relapsed\u002Frefractory peripheral T-cell lymphoma, designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of FG-M131 for injection in this patient population. The study consists of a Phase I dose-escalation stage and a Phase IIa cohort-expansion stage.",[28,29,30],"PTCL","TRBC1 ADC","CTCL",[28,29,30],"NOT_YET_RECRUITING","2026-08-06",{"date":35,"type":36},"2026-08-11","ACTUAL",{"date":38,"type":21},"2026-08-30",{"date":40,"type":21},"2031-04",{"name":42,"class":43},"FutureGen Biopharmaceutical (Beijing) Co., Ltd","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100648633","phase-1-shr2554-plus-liposomal-mitoxantrone-as-first-line-treatment-for-peripheral-t-cell-lymphoma-ptcl-100648633","NCT07725705","SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)","An Open-label, Multicenter, Phase Ib\u002FII Exploratory Clinical Study of EZH2 Inhibitor SHR2554 in Combination With Liposomal Mitoxantrone for the First-line Treatment of Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n1. Age ≥18 years old,regardless of gender;\n2. Centrally confirmed histopathological\u002Fcytologic diagnosis of PTCL with the following subtypes:Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS; Enteropathy-associated T-cell lymphoma(EATL); Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.\n3. No prior anti-tumor therapy.\n4. There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET\u002FCT or Computed Tomography (CT) and\u002For Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions \\>1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma;\n5. ECOG performance status score: 0-2;\n6. Expected survival time ≥3 months;\n7. Have adequate organ and bone marrow functiont;\n8. No concurrent hemophagocytic lymphohistiocytosis (HLH). If a patient has clinically diagnosed HLH, enrollment eligibility will be determined by the investigator based on an evaluation of the patient's general physical condition following targeted anti-HLH therapy.\n9. Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of medication; Effective contraception should be used from the time of informed consent until 6 months after the last dose of study drug.\n10. Capable of understanding the study procedures and voluntarily signing a written informed consent form (ICF).;\n\nExclusion Criteria:\n\n1. Prior treatment with epigenetic agents before enrollment;\n2. Patients with a history of severe cardiac disease, history of radiation therapy to the mediastinal\u002Fpericardial region, cumulative anthracycline dose \\> 550 mg (doxorubicin equivalent), prior use of mitoxantrone, baseline left ventricular ejection fraction (LVEF) \\\u003C 50%, or history of exposure to other cardiotoxic drugs;\n3. History of other primary aggressive malignancies that are not in remission, or have been in remission for less than 3 years;\n4. Primary central nervous system (CNS) lymphoma or secondary CNS involvement.\n5. Known allergy or hypersensitivity to the study drugs or their related metabolites;\n6. Currently participating in another clinical study, or less than 4 weeks elapsed from the end of treatment in a previous clinical study to the planned start of study treatment;\n7. Pregnant or lactating women;\n8. Active infections;\n9. Medical History and Concurrent Conditions;\n10. History of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS);\n11. Patients with mental disorders or those unable to provide informed consent\n12. Any other condition deemed by the investigator to be unsuitable for study enrollment;","80 Years",{"count":54,"type":21},44,[24,25],"This is a single-arm, multicenter, Phase Ib\u002FIIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.",[28,58],"First Line Treatment",[60,61,62,63,64],"EZH2 inhibitor","SHR2554","Liposomal Mitoxantrone","First-line Treatment of PTCL","Zeprumetostat","2026-07-21",{"date":67,"type":36},"2026-07-24",{"date":69,"type":21},"2026-08-01",{"date":71,"type":21},"2030-03-01",{"name":73,"class":74},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100641513","a-multi-center-prospective-registry-study-to-analyze-the-clinical-characteristics-and-prognosis-of-different-molecular-subtypes-of-peripheral-t-cell-lymphoma-100641513","NCT07657572","A Multi-center, Prospective, Registry Study to Analyze the Clinical Characteristics and Prognosis of Different Molecular Subtypes of Peripheral T-cell Lymphoma.","Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (EXCELLENT Study)","EXCELLENT","Inclusion Criteria:\n\n* Patients diagnosed with peripheral T-cell lymphoma (PTCL) by histopathology from June 2026 to December 2029 and detected by gene sequencing (NGS) with different molecular subtypes.\n* Patients diagnosed with PTCL by histopathology from January 2026 to June 2026 and NGS detection can be performed if there is tumor tissue.\n* Fully understand the study, voluntarily sign the written informed consent form (ICF), and agree to cooperate with genetic testing, treatment, efficacy assessment and long-term follow-up.\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Female patients who are pregnant, breastfeeding, or of childbearing potential without effective contraception;\n* Subjects with poorly controlled neurological, psychiatric, mental or cognitive disorders that may impair their understanding and signing of the informed consent form as well as adherence to the study procedures;\n* Any other conditions deemed inappropriate for enrollment by the investigator.",{"count":84,"type":21},1000,"OBSERVATIONAL","A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.",[28,88],"T Cell Lymphoma",[90,91],"Peripheral T Cell Lymphoma","molecular subtypes","2026-06-14",{"date":94,"type":36},"2026-06-18",{"date":96,"type":21},"2026-06",{"date":98,"type":21},"2030-12",{"name":100,"class":74},"Ruijin Hospital",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":44},"100642650","phase-3-tr115-vs-investigators-choice-in-relapsedrefractory-peripheral-tnk-cell-lymphoma-100642650","NCT07639879","TR115 VS Investigator's Choice in Relapsed\u002FRefractory Peripheral T\u002FNK Cell Lymphoma","A Randomized, Controlled, Open-label, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of TR115 in Patients With Relapsed and\u002For Refractory Peripheral T\u002FNK-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed peripheral T-cell lymphoma (PTCL), including PTCL-NOS, AITL, ALCL, or NKTCL\n* Received at least one prior systemic therapy and prior exposure to at least one novel agent (e.g., chidamide, pralatrexate, brentuximab vedotin, etc.) or refractory\u002Fintolerant to such therapies\n* Age ≥18 years\n* ECOG performance status 0-1\n* At least one measurable lesion per Lugano 2014 criteria (lymph node ≥1.5 cm in longest diameter or extranodal lesion ≥1.0 cm)\n* Adequate organ function, defined as: ANC ≥1.5 × 10⁹\u002FL, Platelets ≥100 × 10⁹\u002FL, Hemoglobin ≥100 g\u002FL, Total bilirubin ≤1.5 × ULN, ALT\u002FAST ≤2.5 × ULN (≤5 × ULN if liver involvement), Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault), LVEF ≥50%, QTcF \\\u003C450 ms (male), \\\u003C470 ms (female)\n* Willingness to provide archival or fresh tumor tissue\n* Life expectancy ≥3 months\n\nExclusion Criteria:\n\n* Prior treatment with EZH2 or EZH1\u002F2 inhibitors resulting in disease progression (intolerance permitted)\n* Known central nervous system involvement of lymphoma\n* Active uncontrolled infection requiring systemic therapy\n* Significant or uncontrolled cardiovascular disease\n* Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 90 days prior to first dose\n* Pregnancy or lactation, or unwillingness to use effective contraception\n* Other malignancies within 5 years, except adequately treated basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, or thyroid carcinoma\n* Patients planned to receive mitoxantrone liposomal therapy with prior cumulative doxorubicin exposure ≥350 mg\u002Fm² (or equivalent anthracycline exposure)",{"count":109,"type":21},180,[111],"PHASE3","This is a randomized, open-label, multicenter Phase III study evaluating the efficacy and safety of TR115, an EZH2 inhibitor, versus investigator's choice (chidamide, golidocitinib, mitoxantrone liposome, or gemcitabine) in patients with relapsed and\u002For refractory peripheral T\u002FNK-cell lymphoma. Approximately 180 patients will be randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). The study is being conducted at approximately 40 to 60 centers across China.",[28,114],"NK T-Cell Lymphoma","2026-06-06",{"date":117,"type":36},"2026-06-10",{"date":119,"type":21},"2026-07-30",{"date":121,"type":21},"2030-07-30",{"name":123,"class":43},"Tarapeutics Science Inc.",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":44},"100583332","phase-1-nanobody-based-anti-cd5-car-t-for-relapsedrefractory-t-allnhl-100583332","NCT06874946","Nanobody-Based Anti-CD5 CAR-T for Relapsed\u002FRefractory T-ALL\u002FNHL","A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD5-Targeted CAR-T Cells in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoma (T-ALL\u002FNHL): The CONQUER Trial","Phase I\u002FII","Inclusion Criteria:\n\n1. The subject or guardian understands and voluntarily signs the informed consent form (ICF).\n2. Male or female, aged 3-70 years at the time of signing the ICF (inclusive).\n3. Expected survival of at least 12 weeks.\n4. ECOG performance status of 0-2 at the time of ICF signing.\n5. Diagnosis of relapsed\u002Frefractory T-cell lymphoblastic leukemia\u002Flymphoma (R\u002FR T-ALL\u002FNHL) confirmed at screening and meeting at least one of the following criteria:\n\n   1. Bone marrow involvement: Morphologic examination shows ≥5% lymphoblasts, and\u002For\n   2. Cerebrospinal fluid (CSF) involvement: Tumor cells detected in CSF, and\u002For\n   3. Extramedullary disease: Presence of measurable lesions (lymph node\u002Fmass ≥1.5 cm in axial diameter or extranodal lesion ≥1 cm in axial diameter).\n   4. CD5 expression: Tumor cells in bone marrow, peripheral blood, or CSF are CD5-positive by flow cytometry, and\u002For lymph node\u002Fmass or extranodal lesions are CD5-positive by pathology.\n6. Adequate major organ function, defined as:\n\n   1. AST and ALT ≤5× upper limit of normal (ULN).\n   2. Total bilirubin ≤2× ULN.\n   3. Renal function: Serum creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula) or creatinine ≤1.5× ULN.\n7. Blood oxygen saturation \\>92%.\n8. Reproductive health requirements:\n\n   * Fertile men and women of childbearing potential must agree to use effective contraception from ICF signing until 2 years after study drug administration.\n   * Women of childbearing potential (pre-menopausal or within 2 years post-menopause) must have a negative blood pregnancy test at screening.\n\nExclusion Criteria:\n\n1. History of central nervous system (CNS) diseases, including but not limited to:\n\n   * Epilepsy\n   * Paralysis\n   * Aphasia\n   * Stroke\n   * Severe brain injury\n   * Dementia\n   * Parkinson's disease\n   * Neuropathy\n2. History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:\n\n   * Crohn's disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus (SLE)\n   * Systemic sclerosis\n   * Inflammatory bowel disease (IBD)\n   * Vasculitis\n   * Psoriasis\n3. Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment.\n4. Positive virological or infectious disease markers, including:\n\n   * Hepatitis B virus (HBV): Subjects with positive HBsAg or HBcAb-positive at screening must have undetectable HBV DNA in peripheral blood to be eligible; otherwise, they should be excluded.\n   * Hepatitis C virus (HCV): Subjects with positive HCV antibodies and detectable HCV RNA should be excluded.\n   * Human immunodeficiency virus (HIV) antibody-positive subjects should be excluded.\n   * Cytomegalovirus (CMV) DNA test-positive subjects should be excluded.\n   * Epstein-Barr virus (EBV) DNA test-positive subjects should be excluded.\n   * Positive serological or non-specific antibodies for Treponema pallidum (syphilis).\n5. Clinically significant cardiovascular diseases, including any of the following:\n\n   1. QTc interval ≥480 ms (Fridericia correction formula)\n   2. New York Heart Association (NYHA) Class II or higher heart failure\n   3. Unstable angina or acute myocardial infarction within 6 months prior to signing the ICF\n   4. Left ventricular ejection fraction (LVEF) \\\u003C50%\n   5. Poorly controlled hypertension (as determined by the investigator)\n   6. Clinically significant arrhythmias or those requiring antiarrhythmic treatment, including:\n\n      * Persistent ventricular tachycardia\n      * Ventricular fibrillation\n      * Torsades de pointes\n      * Complete left bundle branch block\n6. History of severe hypersensitivity or allergy to any components of the study drug.\n7. Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator).\n8. Receipt of extensive radiotherapy within 4 weeks prior to signing the ICF, except for palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study.\n9. Unresolved toxicity from prior antitumor therapy that has not returned to Grade 1 or baseline levels at the time of signing the ICF, except for hair loss and pigmentation (per NCI-CTCAE v5.0).\n10. Requirement for systemic corticosteroids or other immunosuppressive therapy (≥10 mg\u002Fday prednisone or equivalent) within 3 days prior to apheresis or during the study period, except for:\n\n    1. Intranasal, inhaled, or topical steroids, or localized steroid injections (e.g., intra-articular injections)\n    2. Systemic corticosteroids ≤10 mg\u002Fday prednisone (or equivalent physiological dose)\n    3. Steroids as prophylaxis for allergic reactions (e.g., pre-medication before contrast-enhanced CT)\n    4. Steroids used for symptomatic treatment of transfusion-related reactions\n11. Major surgery within 4 weeks prior to signing the ICF (excluding routine biopsy procedures) or planned major surgery during the study period.\n12. History of active tuberculosis infection within 1 year prior to signing the ICF, except for subjects with a history of tuberculosis more than 1 year ago, provided that the investigator determines there is no evidence of active tuberculosis.\n13. History of other primary malignancies within 5 years prior to signing the ICF, except for:\n\n    1. Adequately treated carcinoma in situ of the cervix\n    2. Localized basal cell carcinoma or squamous cell carcinoma of the skin\n14. Receipt of live-attenuated or inactivated vaccines within 4 weeks before signing the ICF or planned vaccination during the screening period.\n15. Any other condition or complication that, in the investigator's judgment, may affect adherence to the study protocol or make the subject unsuitable for participation.\n16. Pregnancy or lactation.","3 Years","70 Years",{"count":135,"type":21},30,[24,25],"To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL\u002FNHL",[139,140,28],"Precursor T-Cell Lymphoblastic Leukemia-Lymphoma","T - Cell Lymphoma",[142,143,144],"CD5","R\u002FR T-ALL\u002FLBL","R\u002FR PTCL","RECRUITING","2026-05-01",{"date":148,"type":36},"2026-05-07",{"date":150,"type":36},"2025-02-14",{"date":152,"type":21},"2027-12-31",{"name":154,"class":74},"Peking University People's Hospital",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100630873","phase-1-genotype-guided-targeted-agents-plus-ezh2i-for-primary-refractory-ptcl-100630873","NCT07493330","Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL","Genotype-guided Targeted Agents in Combination With EZH2 Inhibitor, Zeprumetostat for Primary Refractory Peripheral T-cell Lymphoma (PTCL), a Prospective, Open-label, Multi-center Study","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* Patients with a histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) based on 2016 WHO classification\n* Previously treated with 3 or 6 cycles of a CHOP-like regimen as first-line therapy and considered primary refractory. Patients with anaplastic large cell lymphoma (ALCL) must have adequately received brentuximab vedotin (BV) as part of their first-line treatment.\n* Tumor tissue genotyping performed and results available prior to enrollment.\n* ECOG 0, 1, or 2.\n* Life expectancy greater than 3 months.\n* Adequate organ function\n* Contraception during study\n* Informed consented\n\nExclusion Criteria:\n\n* Has a prior malignancy other than the malignancies under study within 3 years without relieve\n* Primary CNS lymphoma\n* Known hypersensitivity to any study drug.\n* Pregnant or lactation\n* Active infection.\n* Diseases and medical history:\n\n  1. Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers\n  2. Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);\n  3. Has a history of psychoactive substance abuse that cannot be discontinued\n  4. Has any severe and\u002For uncontrolled disease.\n* Uncontrollable autoimmune disease,\n* Not able to comply to the protocol for mental or other unknown reasons\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.",{"count":163,"type":21},86,[24,25],"To evaluate the safety and efficacy of Zeprumetostat-based combination therapy, selected according to genotyping results, in patients with primary refractory peripheral T-cell lymphoma (PTCL).",[28,167],"Refractory",[28,169,64,167],"Genotype-guided","2026-04-01",{"date":172,"type":36},"2026-04-07",{"date":174,"type":21},"2026-03-23",{"date":176,"type":21},"2030-12-12",{"name":100,"class":74},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":28,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100419861","phase-2-randomized-phase-iib-trial-of-oral-azacytidine-plus-romidepsin-versus-investigators-choice-in-ptcl-100419861","NCT04747236","Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL","A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in Patients With Relapse or Refractory Peripheral T-cell Lymphoma (PTCL)","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nPatients must have histologically confirmed relapsed or refractory peripheral T-cell lymphoma as defined by 2016 WHO criteria (Section 13.7), who have progressed following one line of prior systemic therapy.\n\n1. Patients are required to have no more than 3 lines of prior therapy (with cytoreductive therapy \\[ex ICE, DHAP, etc.\\] followed by autologous stem cell transplant counting as one line of therapy). Patients are eligible if they have relapsed after prior autologous or allogeneic stem cell transplant.\n2. Patients with anaplastic large cell lymphoma are required to have received brentuximab vedotin (Bv) prior to study enrollment.\n3. Measurable Disease as defined in Section 8.1.3.1.\n4. Age ≥18 years.\n5. ECOG performance status ≤2\n6. Patients must have adequate organ and marrow function as defined below:\n\n   Absolute neutrophil count (ANC): ≥1000\u002Fmm3 (≥1000\u002FdL); Platelets: \\> 75,000\u002Fmm3; Serum Creatinine:\\\u003C 2 x ULN OR creatinine clearance \\>50 mL\u002Fmin\u002Ffor patients with creatinine levels above ULN; Bilirubin: ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN is allowed); AST and ALT: ≤ 2 x ULN OR ≤ 3 X ULN in presence of demonstrable liver involvement; Serum potassium: ≥ 3.8 mmol\u002FL; Serum magnesium≥1.8 mg\u002FdL.\n7. Negative urine or serum pregnancy test for females of childbearing potential\n8. All females of childbearing potential and male subjects must agree to use an effective method of contraception (see section 5.4 for more details)\n9. Be willing and able to provide written consent or assent for the trial.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Diagnosis of patch\u002Fplaque stage mycosis fungoides\n2. Prior Therapy: Prior exposure to any hypomethylating agent or any histone deacetylase inhibitor (ex: romidepsin, chidamide, belinostat, or vorinostat); exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.\n3. Systemic steroids that have not been stabilized to the equivalent of ≤10 mg\u002Fday prednisone prior to the start of the study drugs.\n4. No other concurrent investigational agents are allowed within 2 weeks of enrollment.\n5. Known central nervous system metastases, including lymphomatous meningitis\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Nursing women\n8. Other active concurrent malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast (DCIS or LCIS). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3-years. Patients whose lymphoma has transformed from a less aggressive histology remain eligible.\n9. Patients known to be Human Immunodeficiency Virus (HIV)-positive.\n10. Patients with active Hepatitis A, hepatitis B, or hepatitis C infection.\n11. Concomitant use of CYP3A4 inhibitors (see Section 13.3)\n12. History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and\u002For predispose the subject to an increased risk of gastrointestinal toxicity\n13. Abnormal coagulation parameters (PT \\>15 seconds, PTT\\>40 seconds, and\u002For INR \\>1.5) unless related to ongoing anticoagulation treatment required by the patient.\n14. Known or suspected hypersensitivity to azacitidine (or any excipients in the formulation) or mannitol.\n15. Any known cardiac abnormalities such as:\n\n    * Congenital long QT syndrome\n    * QTc interval ≥ 500 millisecond (using the Fridericia formula)\n    * Patients taking drugs leading to significant QT prolongation (See Section 13.2)\n    * Myocardial infarction within 6 months of C1D1. \\[Subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event, may participate\\];\n    * Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin);\n    * Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Section 13.4) In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;\n    * An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;\n    * Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Section 13.5) and\u002For ejection fraction \\\u003C40% by MUGA scan or \\\u003C50% by echocardiogram and\u002For MRI;\n    * A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest;\n    * Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes;\n    * Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160\u002F95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or\n    * Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)",{"count":186,"type":21},50,[25],"The purpose of this study is to find out whether the combination treatment of romidepsin and oral azacytidine is safe and effective in patients with Peripheral T-Cell Lymphoma (PTCL). This study will compare the experimental combination treatment of romidepsin and oral azacytidine to single agent drugs already determined effective in patients with PTCL. For the purposes of this study, the single agent drugs already used to treat lymphoma are called investigator's choice (IC), meaning the investigator will choose which one of these drugs to administer. The IC drug options include romidepsin, belinostat, pralatrexate or gemcitabine given alone. Funding Source: FDA OOPD.",[28],"2026-01-20",{"date":192,"type":36},"2026-01-21",{"date":194,"type":36},"2021-02-19",{"date":196,"type":21},"2030-06-02",{"name":198,"class":74},"University of Virginia",6,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":44},"100619643","phase-2-shr2554-as-maintenance-therapy-in-patients-with-peripheral-t-cell-lymphoma-100619643","NCT07347288","SHR2554 as Maintenance Therapy in Patients With Peripheral T-cell Lymphoma","An Open-label, Multicenter Exploratory Clinical Study of the EZH2 Inhibitor SHR2554 as Maintenance Therapy After First-line Systemic Treatment in Patients With Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Histologically confirmed PTCL,including PTCL NOS, ALCL, nTFHL,MEITL,ENKTL etc. according to WHO 2022 criteria.\n3. Previously received first-line systemic induction therapy and achieved CR\u002FPR; Auto-transplantation or allo-transplantation are allowed.\n4. A measurable or evaluable disease at the time of first diagnosis of PTCL (any nodes\u002Fnodal masses\\>1.5 cm in longest diameter (LDi) or extralymphatic sites of disease \\>1.0 cm in LDi)\n5. ECOG PS 0-2\n6. With adequate organ function\n7. Expected survival ≥ 12 weeks\n8. Women of childbearing potential (WOCBP) should be proven to be negative by human chorionic gonadotropin (hCG) test in 7 days before the first dose of SHR2554. They must be willing and able to employ a highly effective method of birth control\u002Fcontraception to prevent pregnancy from the day they sign the informed consent form (ICF) to at least 30 days after receiving the last dose of study treatment. Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control\u002Fcontraception to prevent pregnancy；\n9. Participant who has provided written consent to participate in the study and ability to comply with all aspects of the protocol.\n\nExclusion Criteria:\n\n1. cutaneous T cell lymphoma\n2. Has a prior malignancy other than the malignancies under study within 3 years without relieve\n3. Participants with a presence of central nerves invasion\n4. Known sensitivity or allergy to investigational product\n5. Participated in another clinical trial within 4 weeks prior to the start of the study;\n6. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures\n7. Active infected persons, except tumor-related B symptom fever;\n8. Diseases and medical history:\n\n1.have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 2.have a history of psychotropic substance abuse and can not quit or have mental disorders; 3.Subjects with any severe and\u002For uncontrolled medical condition; 9.A history of immunodeficiency 10.Patients with mental disorders or those unable to provide informed consent 11.In any conditions which investigator considered ineligible for this study.",{"count":135,"type":21},[25],"Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma",[28],"2026-01-09",{"date":213,"type":36},"2026-01-16",{"date":215,"type":21},"2026-02",{"date":217,"type":21},"2029-06",{"name":219,"class":74},"The First Affiliated Hospital with Nanjing Medical University",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":44},"100513628","a-retrospective-clinical-study-on-the-first-line-maintenance-treatment-of-ptcl-with-chidamide-100513628","NCT05967949","A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.","A Retrospective (Non-interventional) Clinical Study on the First-line Maintenance Treatment of Peripheral T-cell Lymphoma (PTCL) With Chidamide.","Inclusion Criteria:\n\n* (1) Age: 18 years and older; (2) Gender: Male\u002FFemale; (3) Diagnosed with PTCL; (4) Received chidamide as maintenance therapy after first-line treatment.\n\nExclusion Criteria:\n\n* (1) Patients with other types of lymphomas; (2) Pregnant women.",{"count":228,"type":21},200,"The efficacy and safety of chidamide in first-line maintenance therapy for PTCL will be assessed through a retrospective case analysis.",[28],[232,233],"chidamide","maintenance treatment","2023-07-23",{"date":236,"type":36},"2023-08-01",{"date":238,"type":36},"2023-04-01",{"date":240,"type":21},"2028-04-01",{"name":219,"class":74}]