[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nodal-t-follicular-helper-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nodal-t-follicular-helper-cell-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100634136","phase-2-aclarubicin-plus-cyclophosphamide-vincristine-and-prednisone-caop-in-patients-with-previously-untreated-peripheral-t-cell-lymphoma-100634136",false,"NCT07535762","Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T-Cell Lymphoma","A Prospective, Single-Arm, Multi-center, Phase 2 Study of Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T-Cell Lymphoma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form\n2. Age ≥ 65 years at enrollment\n3. ECOG performance status score ≤ 2\n4. Able to comply with the research visit plan and other protocol requirements\n5. Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) who have not previously received treatment\n\n   The following subtypes as defined by the World Health Organization (WHO) classification (2022) are eligible, with Ann Arbor stage I-IV, and pathological immunohistochemical CD30 negative:\n   1. Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS)\n   2. Nodal T-follicular helper cell lymphoma (TFH)\n   3. Anaplastic large cell lymphoma, ALK-negative (ALCL)\n6. Life expectancy ≥ 3 months\n7. Hematological, renal, and hepatic function all meet the requirements:\n\n   1. Absolute neutrophil count (ANC) ≥ 1,500\u002FμL\n   2. Platelet count ≥ 100,000\u002FμL\n   3. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the institution (except for patients with Gilbert's syndrome)\n   4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; if liver involvement is known, then ≤ 5.0 × ULN\n   5. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance \\> 50 mL\u002Fmin calculated by the Cockcroft-Gault formula\n\nExclusion Criteria:\n\n1. Mental illness, disability, or social circumstances that may affect participant safety, ability to provide informed consent, or poor adherence\n2. Other types of lymphoma\n3. Previous immunotherapy or chemotherapy for PTCL, excluding those who used corticosteroids (≤8 days) prior to enrollment\n4. Previous radiotherapy for PTCL, excluding those confined to a single lymph node region\n5. Pathological immunohistochemistry showing CD30 positivity and\u002For ALK positivity\n6. Patients planning to receive autologous or allogeneic transplantation as first-line consolidation therapy\n7. Confirmed central nervous system\u002Fmeningeal involvement\n8. Significant uncontrolled comorbidities or infections, specifically:\n\n   1. Uncontrolled infection requiring intravenous antibiotics\n   2. Clinically significant heart disease (NYHA Class III or IV), unstable angina\n   3. History of angioplasty, stent implantation, or myocardial infarction within the past 6 months\n   4. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg) despite using two antihypertensive medications. (or diastolic blood pressure \\>100 mmHg, measured twice consecutively, one week apart)\n   5. Clinically significant cardiac arrhythmias\n   6. Uncontrolled diabetes\n9. Known or detected positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B, or hepatitis C.\n10. Patients diagnosed with malignancy within the past two years. However, the following are excluded: non-melanoma skin cancer, melanoma in situ, localized prostate cancer (current PSA \\\u003C0.1 ng\u002FmL), treated thyroid cancer; or cervical carcinoma in situ or breast ductal\u002Flobular carcinoma in situ within the past two years, provided there is currently no evidence of active disease.","ALL","65 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of rare disorders that result from clonal proliferation of mature post-thymic lymphocytes. These T-cell neoplasms account for approximately 10-15% of all lymphomas. The most common subtype of PTCL is classified as \"not otherwise specified\" (NOS) which accounts for 30-40%.\n\nPTCLs have been treated similarly with CHOP (Cyclophosphamide, Hydroxydaunorubicin, Vincristine and Prednisone), often with etoposide (CHOEP), followed by high-dose therapy and autologous stem cell transplantation (ASCT) in first remission. However, \\\u003C50% of the patients are cured with CHOP alone, and the progression-free survival rates at 5 years are as low as 20% for PTCLs. Meanwhile, for elderly patients who can't endure CHOPE and proceed ASCT, the long-term survival is even worse.\n\nAclarubicin is an anthracycline which showed good safety profile in the treatment of both myeloid and lymphocytic leukemia. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached.\n\nThe purpose of this study is to determine the efficacy of Aclarubicin, Cyclophosphamide, Vincristine, and Prednisone (CAOP) in elderly patients with newly diagnosed PTCLs. The investigators hope to try to replace doxorubicin in CHOP with aclarubicin, which is less toxic, without reducing the efficacy of patients while ensuring safety.",[26,27,28],"Peripheral T-Cell Lymphoma (PTCL NOS)","Nodal T-follicular Helper Cell Lymphoma","Anaplastic Large Cell Lymphoma (ALCL) (ALK-1 Negative)",[30,31,32,33],"PTCL","aclarubicin","elderly patients","ALCL, ALK-negative","NOT_YET_RECRUITING","2026-04-14",{"date":37,"type":38},"2026-04-17","ACTUAL",{"date":40,"type":20},"2026-03-30",{"date":42,"type":20},"2028-12-30",{"name":44,"class":45},"Shanghai Jiao Tong University School of Medicine","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":17,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100542806","phase-2-linperlisib-based-treatment-regimen-in-newly-diagnosed-nodal-t-follicular-helper-cell-lymphoma-ntfhl-100542806","NCT06347653","Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL)","A Single Arm, Open Label, Multicenter Clinical Trial of Linperlisib Combined With CHOP Regimen Followed by Autologous Hematopoietic Stem Cell Transplantation and Linperlisib Monotherapy Maintenance for Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL) Patients","Inclusion Criteria:\n\n1. Histologically confirmed nTFHL classified by WHO-HAEM5, including nodal TFH cell lymphoma, angioimmunoblastic-type, nodal TFH cell lymphoma, follicular-type, Nodal TFH cell lymphoma, NOS\n2. Patients planning to receive autologous hematopoietic stem cell transplantation;\n3. No previous systemic treatment before enrollment.;\n4. There is at least one measurable lesion: the longest diameter (LDi) of the lymph node lesion is greater than 1.5 cm, or the LDi of one extra lymph node lesion is greater than 1 cm (according to the 2014 Lugano classification);\n5. Age range from 18 to 65 years old, regardless of gender;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)≤2;\n7. Expected survival time≥12 weeks;\n8. Adequate bone marrow and organ functions; For female participants of childbearing period, a negative urine or serum pregnancy test should be performed with 1 week prior to receiving first dose of investigational drug (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required.WOCBP subjects and male subjects whose partners are WOCBP should agree to use effective contraception from the time of signing the ICF until 6 months after the last dose of study drug.\n9. Adequate organ and bone marrow function without severe hematopoietic abnormalities and abnormal heart, lung, liver, kidney, thyroid function and immunodeficiencies (no blood transfusion, granulocyte colony-stimulating factor or other related medical support within 14 days prior to administration of study drug):\n\n   1. Routine blood tests (not transfused, not on granulocyte colony-stimulating factor (G-CSF), not corrected with medication within 14 days prior to screening): hemoglobin (Hb) ≥ 90 g\u002FL; neutrophils (ANC) ≥ 1.5 x 10 9\u002FL; platelets (PLT) ≥ 100 x 109\u002FL;\n   2. Biochemical tests: TBIL \\\u003C1.5 × upper limit of normal range (ULN); glutamate alanine aminotransferase (ALT) and glutamate aspartate aminotransferase (AST) ≤2.5 × ULN; serum creatinine (Cr) ≤1.25 × ULN or endogenous creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula);\n   3. Coagulation (unless the subject is receiving anticoagulant therapy and coagulation parameters (PT\u002FINR and APTT) are within the expected range for treatment with anticoagulants at screening): international normalized ratio (INR) ≤ 1.5 x ULN; activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.\n10. Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.\n\nExclusion Criteria:\n\nIf a patient has any of the following conditions should not be included in this study:\n\n1. Known allergy to the active ingredients or excipients of linperlisib and CHOP regimens.\n2. Patients with factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);\n3. Medical History and comorbidity\n\n   1. The subject had any active, known, or suspected autoimmune disease. Subjects who are in a stable state and do not require systemic immunosuppressive therapy are admitted;\n   2. Known history of interstitial pneumonia;\n   3. Current or previous history of other malignancies within 2 years prior to study enrollment.Radically treated basal cell carcinoma of the skin, papillary thyroid carcinoma, squamous skin carcinoma, carcinoma in situ of the breast and carcinoma in situ of the cervix, excepted\n   4. Received systemic antitumor therapy, including chemotherapy, immunotherapy, and biotherapy (tumor vaccines, cytokines, or growth factors used to control cancer) within 28 days prior to study enrollment.\n   5. Received autologous or allogeneic hematopoietic stem cell transplantation;\n   6. Patients with active tuberculosis (TB) should be excluded.\n   7. Severe acute or chronic infections requiring systemic treatment;\n   8. Patients with hypertension that is not well controlled with antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)\n   9. Poor diabetes control (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n   10. Patients with heart failure (New York Heart Association standard Class III or IV), poor coronary artery disease control or arrhythmia, or a history of myocardial infarction within the 6 months prior to screening despite receiving appropriate medication;\n   11. Had clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, or vasculitis;\n   12. Renal failure requiring hemodialysis or peritoneal dialysis;\n   13. Urine routine indicated urinary protein ≥++, and 24-hour urinary protein quantity \\> 1.0 g；\n   14. Patients who have had major surgery or severe trauma have had the effects of the surgery or trauma resolved for less than 28 days prior to enrollment；\n   15. Complicated interstitial lung disease or history of severely impaired lung function;\n   16. Patients requiring systemic therapy with corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to administration of study drug. Inhaled or topical steroids and adrenal hormone replacement at doses \\> 10 mg\u002Fday prednisone efficacy dose are allowed in the absence of active autoimmune disease;\n4. Physical and laboratory findings\n\n   1. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).\n   2. Active hepatitis \\[Hepatitis B: Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive and ALT above the upper limit of detection; Hepatitis C: Hepatitis C virus (HCV) ribonucleic acid (RNA) positive and ALT above the upper limit of detection\\]; co-infection with Hepatitis B and Hepatitis C;\n5. Any medical history or disease evidence that may interfere with the study results or other conditions that investigators consider inappropriate for the study.\n6. Pregnant or lactating women.","18 Years",{"count":55,"type":20},54,[23],"This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients.",[27],[60,61,62,63],"nodal T-follicular helper cell lymphoma","linperlisib","autologous hematopoietic stem cell transplantation","maintenance treatment","RECRUITING","2024-04-02",{"date":67,"type":38},"2024-04-04",{"date":69,"type":38},"2023-11-28",{"date":71,"type":20},"2030-01-31",{"name":73,"class":45},"Peking University",1]