[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-peripheral-t-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-peripheral-t-cell-lymphoma":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100640296","phase-1-adebrelimab-combined-with-shr2554-in-relapsedrefractory-ptcl-and-nkt-cell-lymphoma-100640296",false,"NCT07615283","Adebrelimab Combined With SHR2554 in Relapsed\u002FRefractory PTCL and NK\u002FT-Cell Lymphoma","A Single-Arm, Multicenter, Phase Ib\u002FII Exploratory Study to Evaluate Adebrelimab in Combination With EZH2 Inhibitor SHR2554 for the Treatment of Relapsed or Refractory Peripheral T-Cell Lymphoma and NK\u002FT-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:\n\n   1. Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);\n   2. Systemic anaplastic large cell lymphoma (ALK+ and ALK-);\n   3. Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS;\n   4. NKTCL\n   5. and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.\n3. Met the criteria of relapsed\u002Frefractory lymphoma: Relapsed lymphoma was defined as relapsed lymphoma after achieving complete response (CR) or partial response(PR)after initial therapy. Refractory is defined as having an evaluation of progressive disease (PD) after 2 cycles, or stable disease (SD) after 4 cycles of a previous systemic therapy regimen.\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 function, defined as follows(The patients had not received granulocyte growth factor, platelet transfusion, or red blood cell transfusion within 14 days before the examination):\n\n   1. Blood routine: absolute neutrophil count (ANC) ≥ 1.0×109\u002FL;\n   2. platelet count (PLT) ≥ 60×109\u002FL;\n   3. hemoglobin (HGB) ≥ 8.0 g\u002FdL;\n   4. white blood cell (WBC) ≥ 3.5×109\u002FL;\n   5. Renal function: serum creatinine (Cr) ≤1.5×ULN.or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n   6. serum total bilirubin (TBIL) ≤1.5× upper limit of normal value ;\n   7. alanine aminotransferase (ALT) and aspartate transferase (AST) ≤2.5×ULN ;\n   8. Coagulation function: International Normalized Ratio (INR) ≤1.5 × ULN; Prothrombin Time (PT), Activated PartialThromboplastin Time (APTT) ≤1.5×ULN (unless the subject is receiving anticoagulant therapy, And PT and APTT at screening were within the expected range for anticoagulant therapy).\n   9. Thyroid stimulating hormone (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) within the normal range ±10% (Note: non-autoimmune causes of abnormal TSH, FT3 and FT4 can be maintained in the normal range after replacement treatment of hypothyroidism can be enrolled).\n8. Capable of understanding the study procedures and voluntarily signing a written informed consent form (ICF).;\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.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Patients with hemophagocytic lymphohistiocytosis;\n3. Primary central nervous system (CNS) lymphoma or secondary CNS involvement.\n4. History of allogeneic organ transplantation;\n5. Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 3 years prior to the first dose of study drug (patients who received allo-HSCT \\> 3 years prior to the first dose of study drug and currently have no active graft-versus-host disease \\[GVHD\\] are eligible to enroll);\n6. Known allergy or hypersensitivity to the study drugs or their related metabolites;\n7. Uncontrolled active infection;\n8. 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;\n9. Planned autologous hematopoietic stem cell transplantation (auto-HSCT);\n10. Less than 3 months elapsed since the last dose of prior treatment with any immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4).\n11. Active autoimmune disease that required systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, e.g., type 1 diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, or adrenal\u002Fpituitary insufficiency requiring only physiologic doses of corticosteroids). Patients with an autoimmune disease that did not require systemic treatment within the past 2 years are eligible to enroll;\n12. Required systemic treatment with corticosteroids or other immunosuppressive agents for any condition within 14 days prior to the start of study treatment (except for topical or short-term use of corticosteroids, or corticosteroids used for non-autoimmune conditions such as delayed-type hypersensitivity caused by contact allergens);\n13. Diagnosis of another malignancy within the past 5 years, except for malignancies treated with curative intent, including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast, or carcinoma in situ of the cervix.\n14. Received systemic anti-tumor therapy within 28 days prior to the start of study treatment, including chemotherapy, immunotherapy, and biological therapy (tumor vaccines, cytokines, or growth factors to control cancer);\n15. Underwent major surgery within 28 days, or received radiotherapy within 90 days prior to the start of study treatment;\n16. Received live vaccines within 28 days prior to the start of study treatment (excluding attenuated influenza vaccines);\n17. Patients with a known history of Human Immunodeficiency Virus (HIV) infection and\u002For acquired immunodeficiency syndrome;\n18. Patients with active chronic hepatitis B or active hepatitis C. Hepatitis B SurfaceAntigen (HBsAg) or hepatitis B core Antibody (HBcAb) or Hepatitis C Virus (HCV) during the screening period HCV) antibody positive patients must be further tested for Hepatitis B Virus (HBV) DNA (no more than 2500 copies \u002FmL or 500 IU\u002FmL) and HCV RNA (no more than the lower limit of detection of the assay), Enrollment in the trial occurred after the exclusion of patients with active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus (HBV) carriers, medically stable hepatitis B (DNA \\> 2500 copies \u002FmL or 500IU\u002FmL) and cured hepatitis C patients are eligible for enrollment.\n19. Active tuberculosis (TB);\n20. Uncontrolled fungal or bacterial infections;\n21. Known history of alcohol or substance abuse;\n22. Uncontrolled comorbidities, including but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, active peptic ulcer, or bleeding disorders;\n23. History of interstitial lung disease or non-infectious pneumonitis (subjects with a history of asymptomatic drug-induced or radiation-induced non-infectious pneumonitis are eligible for enrollment);\n24. QTcF interval \\> 450 msec, unless secondary to bundle branch block;\n25. History of psychiatric disorders;\n26. Severe concomitant diseases that, in the judgment of the investigator, would compromise patient safety or interfere with the patient's ability to complete the study;\n27. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for inclusion in this study.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","To evaluate the safety of adebrelimab combined with SHR2554 in the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) and NK\u002FT-cell lymphoma (NKTCL), to determine the recommended Phase 2 dose (RP2D) of the combination regimen, and to assess preliminary efficacy.",[27,28],"Relapsed or Refractory Peripheral T Cell Lymphoma","NKTCL",[30,31,32],"SHR2554","adebrelimab","EZH2 inhibitor","NOT_YET_RECRUITING","2026-05-22",{"date":36,"type":37},"2026-05-29","ACTUAL",{"date":36,"type":20},{"date":40,"type":20},"2030-10-29",{"name":42,"class":43},"Sun Yat-sen University","OTHER",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":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100615146","phase-1-mitoxantrone-hydrochloride-liposome-and-enlonstobart-combination-treatment-in-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma-ptcl-100615146","NCT07288814","Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)","A Single-Arm, Open-Label Ib\u002FII Study of Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma（PTCL）","Inclusion Criteria:\n\n1. Centrally confirmed histopathological\u002Fcytologic diagnosis of PTCL with the following subtypes:\n\n   1. Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);\n   2. Systemic anaplastic large cell lymphoma (ALK+ and ALK-);\n   3. Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS;\n   4. and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.\n2. Voluntary participation in clinical study; Fully understand and informed the study and sign the written informed consent;\n3. Age ≥18 years old, and ≤ 75 years old, regardless of gender;\n4. Met the criteria of relapsed\u002Frefractory lymphoma: Relapsed lymphoma was defined as relapsed lymphoma more than 6 months after achieving complete remission (CR) after initial chemotherapy. Refractory lymphoma was defined as any of the following criteria: 1) tumor shrinkage \\\u003C 50% or disease progression after at least 4 courses of standard chemotherapy; 2) achieved CR with standard chemotherapy, but relapsed within half a year;\n5. ECOG performance status score: 0-2;\n6. Expected survival time ≥3 months;\n7. There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma:\n\n1)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; 8.Have adequate organ and bone marrow function, defined as follows:\n\n1. Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109\u002FL(≥1.0×109\u002FL in patients with bone marrow involvement); platelet count (PLT) ≥ 75×109\u002FL(≥50×109\u002FL in patients with bone marrow involvement), hemoglobin (HGB) ≥ 8.0 g\u002FdL; The patients had not received granulocyte growth factor, platelet transfusion, or red blood cell transfusion within 14 days before the examination;\n2. Liver function: serum total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN, liver invasion ≤3.0×ULN); alanine aminotransferase (ALT) and aspartate transferase (AST) ≤2.5×ULN (liver invasion ≤5.0×ULN);\n3. Renal function: serum creatinine (Cr) ≤1.5×ULN.\n4. Coagulation function: International Normalized Ratio (INR) ≤1.5 × ULN; Prothrombin Time (PT), Activated PartialThromboplastin Time (APTT) ≤1.5×ULN (unless the subject is receiving anticoagulant therapy, And PT and APTT at screening were within the expected range for anticoagulant therapy).\n5. Thyroid stimulating hormone (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) within the normal range ±10% (Note: non-autoimmune causes of abnormal TSH, FT3 and FT4 can be maintained in the normal range after replacement treatment of hypothyroidism can be enrolled).\n\n   9.Patients who had received previous antineoplastic therapy could not be enrolled until the toxicity of previous treatment returned to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade score ≤1 or the baseline level; 10.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.\n\nExclusion Criteria:\n\n1. Patients with hemophagocytic lymphohistiocytosis;\n2. Patients with active infection or with obvious B symptoms and high fever should be excluded according to the comprehensive judgment of the investigators;\n3. The subject's previous history of antineoplastic therapy meets one of the following conditions:\n\n   1. Failure to achieve CR or PR after previous treatment with mitoxantrone or mitoxantrone liposome, or relapse within 6 months after treatment;\n   2. Prior treatment with anthracyclines or anthraquinones and cumulative dose of doxorubicin \\> 550 mg\u002Fm2 (liposomal doxorubicin \\> 2000 mg\u002Fm2, epirubicin \\> 1000 mg\u002Fm2, pirarubicin \\> 1000 mg\u002Fm2, mitoxantrone \\> 160 mg\u002Fm2);\n   3. Received anti-tumor treatment (including chemotherapy, targeted therapy, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives (whichever came first) before the first use of the study drug;\n   4. patients who received autologous hematopoietic stem-cell transplantation or allogeneic hematopoietic stem-cell transplantation within 100 days of the first dose of treatment;\n4. Hypersensitivity reaction to any study drug or its components;\n5. Patients with known allergy to any component of the monoclonal antibody;\n6. Patients with a known history of Human Immunodeficiency Virus (HIV) infection and\u002For acquired immunodeficiency syndrome;\n7. Patients with active chronic hepatitis B or active hepatitis C. Hepatitis B SurfaceAntigen (HBsAg) or hepatitis B core Antibody (HBcAb) or Hepatitis C Virus (HCV) during the screening period HCV) antibody positive patients must be further tested for Hepatitis B Virus (HBV) DNA (no more than 1000 copies \u002FmL or 500 IU\u002FmL) and HCV RNA (no more than the lower limit of detection of the assay), Enrollment in the trial occurred after the exclusion of patients with active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus (HBV) carriers, medically stable hepatitis B (DNA \\> 1000 copies \u002FmL or 500IU\u002FmL) and cured hepatitis C patients are eligible for enrollment.\n8. Cardiac function and disease is one of the following:\n\n   1. long QTc syndrome or QTc interval \\>480 ms;\n   2. complete left bundle branch block, degree II or III atrioventricular block;\n   3. severe, uncontrolled arrhythmia requiring medical treatment;\n   4. New York College of Cardiology grade ≥ III;\n   5. cardiac ejection fraction (LVEF) less than 50%;\n   6. a history of myocardial infarction, unstable angina, major unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within 6 months before recruitment;\n9. Receive live attenuated vaccine (except influenza vaccine) within 4 weeks before enrollment or during the study period;\n10. Previous or current concurrent cancer (except for effectively controlled non-melanoma basal cell carcinoma of the skin, breast\u002Fcervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the previous five years);\n11. Those with central nervous system involvement;\n12. Lactating women;\n13. Subjects receiving systemic glucocorticoid therapy or other immunosuppressive therapy for a condition within 14 days before starting study treatment (topical, ocular, intra-articular, nasal, and inhaled glucocorticoids were allowed (minimal systemic absorption); Short-term (≤ 7 days) use of glucocorticoids was permitted for preventive treatment (e.g., contrast allergy) or for the treatment of nonautoimmune conditions (e.g., delayed hypersensitivity from contact allergens).\n14. Had undergone major surgery within 28 days before starting study treatment, or had undergone radiation therapy within the previous 90 days.","75 Years",{"count":54,"type":20},43,[23,24],"To evaluate the safety of mitoxantrone hydrochloride liposome combined with enlonstobart in the treatment of relapsed or refractory peripheral T-cell lymphoma, to determine the optimal dosage of mitoxantrone hydrochloride liposome within the combination regimen, and to assess the efficacy of the combined therapy.",[27],[59,60],"Mitoxantrone Hydrochloride Liposome","Enlonstobart","2025-12-04",{"date":63,"type":37},"2025-12-17",{"date":65,"type":20},"2025-12-08",{"date":67,"type":20},"2027-12-31",{"name":69,"class":43},"Sun Yat-Sen University Cancer Center",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":52,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100503320","phase-2-chidamide-in-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma-rr-ptcl-100503320","NCT05833724","Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R\u002FR PTCL)","A Phase II, Open-label, Single-arm, Multicenter Study of Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n1. Histopathological diagnosis, made by the investigator, of the following PTCL subtypes as defined by the WHO classification (2016) may be included: PTCL, not otherwise specified (PTCL-NOS), anaplastic lymphoma kinase-positive (ALK+) anaplastic large-cell lymphoma (ALCL), ALK-negative (ALK-) ALCL, angioimmunoblastic T-cell lymphoma (AITL), extranodal natural killer (NK)\u002FT-cell lymphoma, nasal type (ENKL), etc., except cutaneous form or leukemic form.\n2. Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline.\n3. Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 prior systemic therapy including, but not limited to, chemotherapy, target therapy, immunotherapy, and autologous stem cell transplantation.\n4. Male or female, aged 20-75 years (inclusive).\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n6. With a life expectancy of ≥12 weeks.\n7. Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug.\n8. Have not received any antibody therapy within 12 weeks prior to the start of study drug.\n9. Willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception.\n2. Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm).\n3. Have been treated with histone deacetylase (HDAC) inhibitor.\n4. With a history of clinically significant QTc prolongation (\\>450 ms for males or \\>470 ms for females), ventricular tachycardia (VT), atrial fibrillation (AF), heart block (HB), myocardial infarction (MI) onset within one year, congestive heart failure (CHF), or any other symptomatic coronary artery disease requiring treatment.\n5. The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10 mm during diastolic period.\n6. With a history of organ transplantation.\n7. With a history of allogeneic stem cell transplantation.\n8. Have received autologous stem cell transplantation within 12 weeks prior to the start of study drug.\n9. Have participated in a clinical trial involving investigational antibody therapy within 12 weeks prior to the start of study drug or non-antibody therapy within 4 weeks prior to the start of study drug.\n10. Have received symptomatic treatment for early myelotoxicity within 7 days prior to the start of study drug.\n11. With active bleeding or newly diagnosed thromboembolic disease, or with hemorrhagic tendency who are using anticoagulants.\n12. With active infection of hepatitis B or C, or persistent fever within 14 days prior to the start of study drug.\n13. With history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome.\n14. Had a major organ surgery within 6 weeks prior to the start of study drug.\n15. With abnormal hepatic function (serum total bilirubin \\>1.5 x upper limit of normal \\[ULN\\]; alanine aminotransferase \\[ALT\\]\u002Faspartate aminotransferase \\[AST\\] \\>2.5 x ULN or \\>5 x ULN if liver metastases are present), abnormal renal function (serum creatinine \\>1.5 x ULN), or abnormal complete blood count (absolute neutrophil counts \\\u003C1500\u002FμL; platelet counts \\\u003C90 x 1000\u002FμL, hemoglobin \\\u003C9 g\u002FdL).\n16. Has known psychiatric disorders or substance abuse disorders that may interfere with the patient's participation in the study or evaluation of the study results.\n17. Considered by the investigator as being not suitable to participate the study.","20 Years",{"count":79,"type":20},33,[24],"This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R\u002FR PTCL.",[83],"Relapsed or Refractory Peripheral T-cell Lymphoma",[85],"PTCL","RECRUITING","2025-03-07",{"date":89,"type":37},"2025-03-11",{"date":91,"type":37},"2024-10-18",{"date":93,"type":20},"2025-12",{"name":95,"class":96},"Great Novel Therapeutics Biotech & Medicals Corporation","INDUSTRY",5,"Relapsed or Refractory Peripheral T-Cell Lymphoma"]