[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-t-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-t-cell-lymphoma":128},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,49,0,25,[9,47,87,115,139,182,214,248,293,320,346,371,394,417,436,460,489,516,537,557,578,606,630,653,678],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100555159","phase-1-intravenous-vesicular-stomatitis-virus-in-patients-with-peripheral-t-cell-lymphoma-100555159",false,"NCT06508463","Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma","MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic\u002FDendritic Cell Neoplasms","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Relapsed or refractory:\n\n  * Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 2 times upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 2.0 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* Direct bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* If baseline liver disease, Child Pugh score not exceeding class A (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test for persons of child-bearing potential (obtained =\\\u003C 15 days prior to registration)\n* FOR T-Cell Lymphoma (TCL)\u002FB-Cell Lymphoma (BCL) ONLY: Absolute Neutrophil Count (ANC) \\>= 1,000\u002Fmicroliter (μL) (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Platelets \\>= 100,000\u002FμL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \\> 2 cm or tumor cells in the blood \\> 5 x 10\\^9\u002FL; NOTE: skin lesions can be used if the area is \\> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory\n* Ability to provide written informed consent\n* Willingness to return to Mayo Clinic for follow-up\n* Life expectancy \\>= 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Willing to provide mandatory biological specimens for research purposes\n\nExclusion Criteria:\n\n* Availability of and patient acceptance of curative therapy\n* Uncontrolled infection\n* Active tuberculosis or hepatitis, or chronic hepatitis\n* Any of the following prior therapies:\n\n  * Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\\\u003C 2 weeks prior to registration\n  * Immunotherapy (monoclonal antibodies) =\\\u003C 4 weeks prior to registration\n  * Experimental agent in case of Acute Myeloid Leukemia (AML) or TCL within 4 half-lives of the last dose of the agent\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias \\[atrial fibrillation or supraventricular tachycardia (SVT)\\]\n* Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)\n* Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \\[FDA\\] approved indication and in the context of a research investigation);\n\n  * NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritus and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant women or women of reproductive ability who are unwilling to use effective contraception\n  * Nursing women\n  * Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)","ALL","18 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus (VSV) carrying the human (h) sodium iodide symporter (NIS) and Interferon (IFN) beta (β) genes (VSV-hIFNβ-NIS) in combination with cemiplimab in patients with T-cell lymphoma. A virus, called VSV-hIFNβ-NIS, which has been changed in a certain way, may be able to kill cancer cells without damaging normal cells. Immunotherapy with ipilmumab and cemiplimab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.",[27,28,29,30,31,32,33],"Peripheral T Cell Lymphoma","Relapsed Peripheral T-Cell Lymphoma","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Anaplastic Large Cell Lymphoma","Mycosis Fungoides","Relapsed Anaplastic Large Cell Lymphoma","Relapsed Mycosis Fungoides","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2024-01-05",{"date":42,"type":21},"2032-04-01",{"name":44,"class":45},"Mayo Clinic","OTHER",2,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":68,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100597206","phase-1-a-phase-i-trial-anti-cc-chemokine-receptor-4-chimeric-antigen-receptor-t-cells-ccr4-car-t-cells-for-ccr4-expressing-t-cell-malignancies-including-peripheral-t-cell-non-hodgkin-lymphoma-ptcl-and-cutaneous-t-cell-non-hodgkin-lymphoma-ctcl-100597206","NCT07055477","A Phase I Trial Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T-cell Malignancies Including Peripheral T-cell Non-Hodgkin Lymphoma (PTCL) and Cutaneous T-cell Non-Hodgkin Lymphoma (CTCL)","A Phase I Trial of Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T-cell Malignancies Including Peripheral T-cell Non-Hodgkin Lymphoma (PTCL) and Cutaneous T-cell Non-Hodgkin Lymphoma (CTCL)","* INCLUSION CRITERIA:\n* Pathologically (biopsy) confirmed histologic diagnosis of a relapsed\u002Frefractory CCR4+ mature T-cell malignancy from one of the following subtypes: peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), hepatosplenic t-cell lymphoma (HSTCL), monomorphic epithelialtropic intestinal lymphoma (MEITL), enteropathy associated T-cell lymphoma (EATL) or cutaneous T-cell lymphoma (CTCL) including mycosis fungoides and subacute panniculitis-like T-cell Lymphoma, or lymphomatous subtypes of ATL without evidence of CNS involvement or substantial circulating disease confirmed by the Laboratory of Pathology, NCI.\n\n  --CCR4+ is defined as \\>= 10% malignant cells positive for CCR4 by immunohistochemistry. It is preferred to have a fresh biopsy to confirm the CCR4 status. In the event a fresh biopsy cannot be safely performed in the opinion of the treating physician, an archival biopsy sample taken at the time of previous progression can be used.\n* Adequate tissue \\[a formalin fixed tissue block or 15 slides of tumor sample (archival or fresh)\\] from diagnostic biopsy (archival or fresh) must be available.\n\nNOTE: Tissue will be used for assessment of CCR4 expression on malignant cells by immunohistochemistry with any leftover slides or samples to be used for correlative studies. Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator. If prior tissue is not available, a screening biopsy will be necessary unless repeat biopsy is deemed unsafe by the treating physician in consultation with the Principal Investigator.\n\n* Participants must have disease that is relapsed or refractory after prior therapy as follows:\n\n  * Participants with ALCL must have failed at least one prior line of Brentuximab-containing therapy.\n  * Due to the generally indolent nature of the disease, participants with Mycosis Fungoides must have exhausted all standard therapies as determined by the enrolling physician and principal investigator to be eligible for this study.\n  * All other participants must have failed at least two lines of prior therapy.\n* Participants must have measurable or evaluable disease at the time of enrollment. For participants with systemic T-cell lymphoma, this is defined by any evidence from CT scan or PET-CT-avid disease based on the Lugano criteria. For participants with Cutaneous T-cell Lymphoma, positive scores based on Modified Severity-Weighted Assessment Tool (mSWAT) criteria are acceptable.\n* Participants must be \\>=18 years of age at the time of signing informed consent.\n* Adequate performance status (PS) as follows: ECOG PS 0-1.\n* Adequate organ function as evidenced by the following laboratory parameters:\n\n  * Absolute neutrophil count (ANC) \\>= 1,000 \u002FmicroL\n  * Platelets \\>= 75,000 \u002F microL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL (transfusions permitted)\n  * Creatinine Clearance \\>= 60 mL\u002Fmin\u002F1.73m\\^2 per Cockcroft Gault equation; For participants \\\u003C 60 per Cockcroft Gault a direct measurement may be used\n  * Serum total bilirubin \\\u003C= 3 X upper limit of normal (ULN)\n  * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \\\u003C= 3 X ULN\n  * Left ventricular ejection fraction \\> 50% by echocardiogram performed\n  * ECG No clinically significant ECG findings (Arrhythmias or evidence of ischemic heart disease with clinical correlate)\n\nNote: Participants with well-controlled atrial fibrillation are eligible.\n\n--FEV1 and DLCO \\> 60% of predicted (adjustment for Hgb acceptable)\n\n-Individuals of child-bearing potential (IOCBP) must have a negative urine or blood HCG pregnancy test at screening.\n\nNOTE: IOCBP is defined as any person assigned female at birth who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\n-Individuals of child-bearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) or practice abstinence starting at the time of study entry, for the duration of study therapy, and 12 months after the last dose of combined chemotherapy.\n\nIndividuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and for 4 months after the last dose of combined chemotherapy. We also will recommend these individuals with partners of childbearing potential ask partners to be on highly effective birth control (hormonal, IUD, surgical sterilization)\n\n* Nursing participants must be willing to discontinue nursing through 12 weeks after cell infusion.\n* Potential participants must agree to stay within 1-hour drive of NIH clinical center from date of initial discharge from hospitalization (no earlier than D+15) through initial D+28 follow-up and be willing and able to return for in-person follow-up visits through month 3 of the study.\n* Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with any current or prior CNS involvement by malignancy are excluded from this study. All potential participants will be screened with brain imaging prior to enrollment on study.\n* Participants with \\>1000 atypical cells\u002Fmm\\^3 by peripheral blood flow cytometry at screening.\n* Participants with a history of serologically or biopsy confirmed autoimmune disorders are excluded from this study. As an exception, participants with EATL whose celiac disease is well controlled and who will maintain a strict gluten-free diet are eligible.\n\nParticipants with prior autoimmune thyroiditis who are now on stable thyroid replacement therapy are also eligible.\n\n* HTLV I\u002FII positive participants with a history of HTLV-associated myelopathy\u002Ftropical spastic paraparesis (TSP)\n* Participants who have received prior CD25-directed therapy.\n* Current or prior anti-cancer treatment prior to the first dose of study drug as defined below:\n\n  * Any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies within 2 weeks before the start of lymphodepleting chemotherapy.\n  * High doses of systemic corticosteroids (\\>20 mg prednisone or equivalent) 5 days before apheresis and\u002For 5 days before CAR T cell infusion.\n  * Participants who have not reached D+100 following auto-SCT or who have any unresolved Auto-SCT related complications (e.g. pneumonitis).\n  * Participants who have undergone prior allogeneic stem cell at any time.\n* Participants taking any investigational agents for any disease\u002F condition.\n* Seropositive for human immunodeficiency virus (HIV).\n* Active bacterial infections or active viral infections (CMV, syphilis)\n* Uncontrolled EBV infection Note: EBV positive test is allowed due to frequent association of active EBV with mature T-cell malignancies, which frequently resolve with improved control of the malignancy. EBV positive participants may be treated with rituximab or biosimilar prior to lymphodepleting chemotherapy at investigator s discretion.\n* Active hepatitis C infection.\n\nNOTE: Participants seropositive for hepatitis C virus (HCV) infection must have been treated and cured as defined by undetectable HCV viral load.\n\n-Active hepatitis B infection.\n\nNOTE: Participants that are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) must have a negative hepatitis B virus polymerase chain reaction (HBV PCR) result \\\u003C100 IU\u002FmL at screening. Those who are HBV PCR positive are excluded. Those hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with a negative PCR for hepatitis B will be treated with antivirals designed to prevent hepatitis B reactivation (e.g., entecavir) and have monitoring for hepatitis B reactivation with PCR.\n\n* Participants with current cardiac atrial or cardiac ventricular lymphoma involvement.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months of enrollment.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computer tomography (CT) scan at screening.\n\nNOTE: History of radiation pneumonitis in the radiation field (fibrosis) is allowed.\n\n* History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* Deep vein thrombosis or pulmonary embolism requiring ongoing systemic anticoagulation\n* History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study\n* Participants with second malignancies in addition to their T-cell malignancy are not eligible if the second malignancy has required treatment (including maintenance therapy) within the past 3 years or is not in complete remission. There are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinoma.\n* Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the participant.","120 Years",{"count":56,"type":21},60,[24],"Background:\n\nChemokine receptor 4 (CCR4) is a protein that is found on the surface of certain T-cell lymphoma cells and is common in mature T-cell cancers. White blood cells can be changed with molecules called anti-CCR4 to express a chimeric antigen receptors (CAR), which is a molecule that directs a white blood cell to attack other cells. The CAR in this study attacks the CCR4 protein found on your T-cell lymphoma. This type if therapy is called gene therapy. Gene therapy involves a person s own white blood cells modified to target cancer cells. More research is needed to find out if gene therapy can treat T-cell cancers and do it safely.\n\nObjective:\n\nTo test safety of giving people with certain mature T-cell lymphomas their own white blood cells modified with anti-CCR-4 CAR.\n\nEligibility:\n\nPeople aged 18 and older with certain mature T-cell lymphomas that have not responded to or have come back after treatment. They must have a T-cell lymphoma that has CCR4 on the surface of the cancer cells.\n\nDesign:\n\nParticipants will be screened. They will have a medical history and physical exam. Tests of blood, urine, and heart and lung function will be done.\n\nParticipants will have tests:\n\nComputed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging scans: They will lie on a table that slides into a donut-shaped machine or a tube. Pictures of the inside of the body will be taken. Before the PET scan, they will get an injection of radioactive fluid in a vein in the arm. Before the MRI, they may get a contrast dye injected through a vein (IV) in the arm.\n\nA biopsy of the tumor may be taken. A bone marrow sample may be taken from the hip: The area will be numbed and a large needle inserted through the skin.\n\nLeukapheresis will be done to obtain T-cells that will be genetically modified to express anti-CCR4 CARs on T-cells: Blood is drawn through an IV in one arm, circulated through a machine, and then returned through an IV in the other arm.\n\nChemotherapy drugs will be given in an IV to prepare the body to accept the modified CAR T cells.\n\nThe modified cells will be given in an IV.\n\nParticipants will be followed for 15 years: This will require blood tests over the first 1-2 years followed by yearly visits and possibly telehealth updates.",[60,61,62,30,63,64,65,66,31,67],"Relapsed and\u002For Refractory Mature T Cell Malignancy","Peripheral T-Cell Lymphoma","Angioimmunoblastic T-cell Lymphoma","Hepatosplenic T-cell Lymphoma","Monomorphic Epithelialtropic Intestinal Lymphoma","Enteropathy Associated T-cell Lymphoma","Cutaneous T-Cell Lymphoma","Subacute Panniculitis-like T-cell Lymphoma",[69,70,71,72,73,74,75],"CCR4","CAR T","Chemokine Receptor 4","Chimeric Antigen Receptor","Gene Therapy","Cell Therapy","Immunotherapy","2026-06-24",{"date":78,"type":38},"2026-06-25",{"date":80,"type":38},"2025-09-29",{"date":82,"type":21},"2044-06-01",{"name":84,"class":85},"National Cancer Institute (NCI)","NIH",1,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100367769","phase-1-study-to-evaluate-ccs1477-inobrodib-in-haematological-malignancies-100367769","NCT04068597","Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies","An Open-label Phase I\u002FIIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.","Inclusion Criteria:\n\n* Provision of consent\n* ECOG performance status 0-2\n* Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)\n* Must have previously received standard therapy\n* Adequate organ function\n\nExclusion Criteria:\n\n* Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose\n* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment\n* Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment\n* Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment\n* Patients should discontinue statins prior to starting study treatment\n* CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment\n* Any unresolved reversible toxicities from prior therapy \\>CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)\n* Any evidence of severe or uncontrolled systemic diseases\n* Any known uncontrolled inter-current illness\n* QTcF prolongation (\\> 470 msec)",{"count":95,"type":21},250,[24,97],"PHASE2","A Phase 1\u002F2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.",[100,101,102,103,104,27],"Haematological Malignancy","Acute Myeloid Leukemia","Non Hodgkin Lymphoma","Multiple Myeloma","Higher-risk Myelodysplastic Syndrome","2026-06-19",{"date":76,"type":38},{"date":108,"type":38},"2019-08-09",{"date":110,"type":21},"2027-03-31",{"name":112,"class":113},"CellCentric Ltd.","INDUSTRY",39,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100610944","phase-3-a-phase-3-multinational-study-of-golidocitinib-versus-investigators-choice-in-rr-ptcl-jackpot19-100610944","NCT07234162","A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r\u002Fr PTCL (JACKPOT19)","A Phase 3, Open-Label, Randomized, Multinational Study to Investigate the Anti-tumor Efficacy of Golidocitinib Versus Investigator's Choice in Adult Patients With Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* The participants should sign the ICF and be able to comply with the relevant requirements in the ICF and protocol\n* Age ≥ 18 years\n* ECOG 0-2 score, life expectancy ≥ 12 weeks\n* Patients must have histologically confirmed peripheral T-cell lymphoma according to the World Health Organization classification of lymphoma. Eligible subtypes are restricted to: PTCL-not otherwise specified, NOS (PTCL, NOS), Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma ALK-positive (ALCL ALK+), anaplastic large-cell lymphoma ALK-negative (ALCL ALK-), Follicular T-cell lymphoma, or PTCL with T-follicular helper (TFH) phenotype (FTCL or PTCL-TFH), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Natural killer\u002FT-cell lymphoma (NK\u002FTCL), Hepatosplenic T-cell lymphoma (HSTCL), Subcutaneous panniculitis-like T-cell lymphoma (SPTCL)\n* Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator\n* Adequate bone marrow reserve and organ system functions\n* Willing to comply with contraceptive restrictions\n\nExclusion Criteria:\n\n* Any of previous or current treatment prohibited by protocol\n* Any unresolved \\> grade 2 drug-related adverse events\n* Lymphoma involving central nervous system\n* Any of severe cardiac or pulmonary abnormalities\n* Disease condition requires immunosuppressants, biologics, or NSAIDs\n* Active infection\n* Malignancy disease within five years\n* Poorly controlled gastrointestinal disorder or inadequate absorption of medication\n* Severe or poorly controlled systemic diseases",{"count":123,"type":21},218,[125],"PHASE3","This is a phase 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed\u002Frefractory peripheral T-cell lymphoma (r\u002Fr PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory\u002Fintolerant to at least one prior systemic treatment regimen(s).",[128],"Peripheral T-cell Lymphoma","2026-06-04",{"date":131,"type":38},"2026-06-08",{"date":133,"type":38},"2024-05-13",{"date":135,"type":21},"2028-10-31",{"name":137,"class":113},"Dizal Pharmaceuticals",51,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":151,"conditions":152,"keywords":169,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212","NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","0 Years","38 Years",{"count":149,"type":21},30,"OBSERVATIONAL","The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[153,154,155,156,17,157,158,159,160,161,102,162,163,164,165,166,167,27,168],"Hematologic Malignancy","Leukemia","Lymphoma","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","AML","Chronic Myelogenous Leukemia","CML","Myeloproliferative Neoplasm","Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Burkitt Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Cutaneous B-Cell Lymphoma",[170,171,172],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","2026-06-02",{"date":129,"type":38},{"date":176,"type":38},"2023-11-15",{"date":178,"type":21},"2027-12-01",{"name":180,"class":45},"Children's Hospital Medical Center, Cincinnati",5,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":200,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":86},"100620332","phase-2-ruxolitinib-maintenance-post-hematopoietic-stem-cell-transplant-t-cell-lymphoma-100620332","NCT07356245","Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma","Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma","Inclusion Criteria:\n\n1. Adult patients with T-cell lymphoma \\[PTCL (all subtypes), T-PLL, ATLL, and CTCL (all subtypes)\\] in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less\n3. Adequate hematologic function defined by absolute neutrophil count (ANC) \\> 1000\u002Fmm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets \\> 50K\u002Fmm3 without transfusion for at least 3 days and hemoglobin (Hb) \\> 8.0 g\u002FdL without transfusion for at least 3 days.\n4. Adequate organ function defined by total Bilirubin \\\u003C 1.5 x ULN, alanine aminotransferase (ALT) \\\u003C\u002F= 3 x ULN, CKD-EPI eGFR ≥ 30 ml\u002Fmin, SpO2 \\> 92% without supplemental oxygen.\n5. Able to tolerate oral or enteral medications.\n6. Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.\n7. Able to read and sign informed consent.\n\nExclusion Criteria:\n\n1. Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (\\\u003C2) in first complete remission.\n2. Progressive disease or any other systemic therapy post-SCT (radiation allowed)\n3. Disease progression to Ruxolitinib previously\n4. GvHD requiring systemic therapy.\n5. Active uncontrolled infections.\n6. Active thrombotic active microangiopathy requiring therapy.\n7. History of veno-occlusive disorder post-transplant\n8. Use of platelets antiaggregant or anticoagulants deemed to be unsafe to be held in case of thrombocytopenia.\n9. History of life-threatening bleeding defined as any bleeding that required invasive procedures or involving central nervous system.\n10. Pregnancy (positive Beta HCG test in a woman with childbearing potential defined as not postmenopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.\n11. Uncontrolled Hepatitis B\u002FC, HIV, tuberculosis, mycobacterium, or fungal infection.\n12. Exposure to other investigational drugs within 4 weeks before enrollment.\n13. Grade ≥ 3 non-hematologic toxicity from SCT that has not resolved to grade ≤ 2.\n14. Myocardial infarction or stroke within 1 year of study entry.\n15. Any uncontrolled medical problem at the discretion of the investigator that would pose a risk to the patient.",{"count":190,"type":21},44,[97],"This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The \"graft\" is the donor blood cells that patients get during the transplant. The \"host\" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.",[166,194,195,27,196,197,198,199],"Graft Versus Host Disease","Lymphoma, T-Cell","T-cell Prolymphocytic Leukemia","Cutaneous T Cell Lymphoma","Adult T-cell Leukemia\u002FLymphoma","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma",[201,202,203,204],"stem cell transplant","graft versus host disease","lymphoma","leukemia","2026-04-10",{"date":207,"type":38},"2026-04-15",{"date":209,"type":38},"2026-02-12",{"date":211,"type":21},"2027-01-31",{"name":213,"class":45},"Jonathan Brammer",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":222,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":234,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":46},"100529662","phase-1-constitutive-il7r-c7r-modified-banked-allogeneic-cd30car-ebvsts-for-cd30-positive-lymphomas-100529662","NCT06176690","Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas","Constitutive IL7R (C7R) Modified Banked Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas","CABAL2","Inclusion Criteria:\n\n1. Diagnosis and clinical course falling into one of the following categories:\n\n   1. Hodgkin lymphoma\n   2. CD30+ aggressive B-cell lymphoma\n   3. ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma\n   4. ALK-positive anaplastic T cell lymphoma\n2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.\n3. Age 12 to 75.\n4. Bilirubin less than or equal to 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin less than or equal to 3 times the upper limit of normal).\n5. AST less than 3 times the upper limit of normal.\n6. Estimated GFR \\> 70 mL\u002Fmin.\n7. Pulse oximetry of \\> 90% on room air\n8. Karnofsky or Lansky score of \\> 60%.\n9. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.\n10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.\n11. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.\n\nExclusion Criteria:\n\n1. Received an investigational cell therapy or vaccine within the past 6 weeks.\n2. Received an investigational small molecule drug within the past 2 weeks.\n3. Received anti-CD30 antibody-based therapy within the previous 4 weeks.\n4. History of hypersensitivity reactions to murine protein-containing products.\n5. Pregnant or lactating.\n6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).\n7. Current use of systemic corticosteroids at a dose equivalent to or higher than 10 mg\u002Fday of prednisone.\n8. Active significant, uncontrolled bacterial, viral or fungal infection.\n9. Symptomatic cardiac disease (NYHA Class III or IV disease).","12 Years","75 Years",{"count":225,"type":21},90,[24],"This study involves patients with diffuse large B cell lymphoma (DLBCL), natural killer\u002FT-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment.\n\nPrevious research combined antibodies and T cells to treat cancer. Antibodies bind to foreign substances, and T cells are infection-fighting white blood cells that can kill tumor cells. Both approaches have shown promise but have not been sufficient to cure most patients. In prior studies, an antibody targeting CD30, a protein found on some T cells and cancer cells, was joined to T cells through gene transfer to create CD30.CAR T cells.\n\nAnother study showed encouraging responses using CD30.CAR T cells made from a patient's own blood and returned to the same patient (autologous cells). In an ongoing study, patients have been treated with CD30.CAR T cells derived from healthy donors (allogeneic cells), allowing use of banked cells without individualized manufacturing. This approach has shown promising clinical activity with no safety concerns to date.\n\nIn this study, investigators are evaluating CD30.CAR-EBVST cells modified with an additional molecule called C7R, which has been shown in laboratory studies to enhance anti-cancer effects. The study aims to assess the safety and effectiveness of these allogeneic, banked C7R-modified CD30.CAR-EBVST cells and determine whether they may help treat lymphoma.\n\nAs an added safety measure, the modified T cells include a marker called iC9. If significant side effects occur, patients may receive rimiducid, which can eliminate the infused T cells. Rimiducid is not yet FDA approved but has been tested in patients without significant side effects.",[229,230,231,128,232,233,162],"CD30-Positive Diffuse Large B-Cell Lymphoma","Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-negative","Non-Hodgkin Lymphoma",[235,236,237,238],"CD30-Positive Lymphoma","Hodgkin lymphoma","non-Hodgkin lymphoma","CD30 CAR","2026-04-07",{"date":241,"type":38},"2026-04-13",{"date":243,"type":38},"2025-10-27",{"date":245,"type":21},"2043-06-27",{"name":247,"class":45},"Baylor College of Medicine",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":223,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":267,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":86},"100633197","phase-1-adaptive-dual-target-car-t-cells-for-relapsed-or-refractory-hematologic-malignancies-100633197","NCT07523555","Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies","A Phase 1\u002F2, Open-Label, Nonrandomized, Multi-arm Umbrella Study of Biomarker-Selected Dual-Target CAR-T Cell Modules in Adults With Relapsed or Refractory Hematologic Malignancies","ADAPT-HEM","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL\u002FCLL\u002FSLL; multiple myeloma\u002Fplasma cell leukemia; AML\u002Fhigh-risk MDS\u002FBPDCN; or T-ALL\u002FT-LBL\u002Fperipheral T-cell lymphoma.\n* Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative\u002Fapproved standard option judged appropriate by the investigator.\n* Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review.\n* Measurable or otherwise evaluable disease by disease-specific response criteria.\n* ECOG performance status 0 to 2.\n* Adequate organ function: LVEF \\>= 45%; creatinine clearance \\>= 40 mL\u002Fmin; AST\u002FALT \\\u003C= 3 x ULN; total bilirubin \\\u003C= 1.5 x ULN unless due to Gilbert syndrome; oxygen saturation \\>= 92% on room air.\n* Adequate hematologic reserve unless cytopenia is clearly disease-related.\n* Ability to undergo leukapheresis and willingness to comply with study procedures and follow-up.\n* If prior allogeneic HSCT: at least 100 days from transplant, no uncontrolled GVHD, and no systemic immunosuppression above physiologic steroid replacement.\n* Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception during protocol-defined risk periods.\n* Written informed consent obtained before any study-specific procedure.\n\nExclusion Criteria:\n\n* \\- Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.\n* Active symptomatic CNS involvement requiring escalating therapy; previously treated\u002Fstable CNS disease may be allowed if defined prospectively in the final protocol.\n* Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved \\>= Grade 3 toxicity from prior anticancer therapy\n* Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.\n* Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical\u002Finhaled therapy.\n* Prior solid organ transplant.\n* Clinically significant cardiovascular disease, uncontrolled arrhythmia, decompensated heart failure, myocardial infarction within 6 months, or recent stroke within 6 months.\n* Uncontrolled HIV, HBV, or HCV viremia.\n* Pregnancy or breastfeeding.\n* Another active malignancy requiring systemic therapy, unless low-risk and definitively treated per protocol-defined exceptions.\n* Known hypersensitivity to fludarabine, cyclophosphamide, or critical product excipients.\n* Inability to manufacture a releaseable CAR-T product or failure to meet module-specific product-release criteria.\n* Any medical, psychiatric, or social condition that, in the investigator's judgment, would increase risk, impair compliance, or confound interpretation of study results.",{"count":257,"type":21},96,[24,97],"Phase 1\u002F2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19\u002FCD22, CD19\u002FCD20, BCMA\u002FCD19, BCMA\u002FCD38, BCMA\u002FGPRC5D, CD33\u002FCD123, CD33\u002FCLL1, or CD5\u002FCD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response.\n\nLymphodepletion with fludarabine\u002Fcyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.",[261,262,263,264,265,266,128],"Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma or CLL\u002FSLL","Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Relapsed\u002FRefractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm","BPDCN; Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia","T-lymphoblastic Lymphoma",[268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284],"BCMA","biomarker-selected","CD19","CD20","CD22","CD33","CD38","CD123","CD5","CD7","CLL1\u002FCLEC12A","dual-target CAR-T","GPRC5D","hematologic malignancy","MRD negativity","antigen escape","umbrella trial","2026-04-05",{"date":241,"type":38},{"date":288,"type":38},"2026-03-02",{"date":290,"type":21},"2028-02-17",{"name":292,"class":113},"Beijing Biotech",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":223,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":86},"100401844","phase-2-sintilimab-combined-with-chidamide-in-treating-peripheral-t-cell-lymphoma-100401844","NCT04512534","Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma","A Phase II Study of Anti-Programmed Death-1(PD-1) Antibody Sintilimab Plus Histone Deacetylase(HDAC) Inhibitor Chidamide in Patients With Relapsed\u002F Refractory Peripheral T-cell Lymphoma","Sincerely20","Inclusion Criteria:\n\n1. Age range from 18 to 75 years;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n3. Pathologically confirmed relapsed\u002Frefractory Peripheral T-cell lymphoma (Including PTCL-NOS, AITL, anaplastic large cell lymphoma（ALTL）, excluding Nature Killer（NK）\u002FT cell lymphoma);\n4. At least one two-dimensional measurable lesion with a length diameter of at least 1.5cm and vertical diameter of at least 1.0cm (measured by CT or MRI);\n5. Adequate medullary hematopoiesis function ( WBC≥3.5×109\u002FL, ANC≥1.5×109\u002FL, PLT≥80×109\u002FL, HB≥90g\u002FL. If the peripheral blood indicators demonstrate abnormal due to bone marrow or spleen invasion by lymphoma, Enrollment decision can be determined by the investigator as appropriate;\n6. Adequate hepatic function (total serum bilirubin, ALT and AST≤1.5 times of upper limit of normal);\n7. Adequate renal function (serum creatinine≤1.5 times the upper limit of normal, creatinine clearence≥50ml\u002Fmin);\n8. Echocardiography or radionuclide cardia functional test, LVEF≥50%;\n9. Patients of child-bearing period agree to use appropriate contraception. The serum pregnancy test of women in childbearing period was negative within 2 weeks before enrollment.\n10. Willingness to provide pathological tissue specimens (20 pieces of wax or paraffin tissue sections);\n11. Expectation survival time over 3 months;\n12. Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients allergic of any drug in this regimen;\n2. Previous treatment with anti-PD-1 antibody combined with HDAC inhibitor (Patients only received single agent of treatment regime or sequentially received anti-PD-1 and HDAC inhibitor are allowed to enroll);\n3. Patients with clinically significant heart disease, including severe cardiac insufficiency: New York Heart Disease Association (NYHA) grade IV cardiac insufficiency, unstable angina. And myocardial infarction, congestive heart failure, and QTC interphase \\> 500ms which occurred before 6 month of screening;\n4. Patients who have received grade II or above surgery within 3 weeks before enrollment;\n5. History of other malignancy within the past 5 years (except for 1. basal cell carcinoma of the skin and 2. carcinoma in situ of the cervix and 3. patients who had received treatment for the purpose of cure and had not developed a malignant tumor with a known active disease in the previous 5 years);\n6. Patients who had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of the enrollment (if patients received small-molecule targeted drug therapy, they could be included in the study if the drug was discontinued for more than 5 half-lives), or had not recovered from the previous toxicity;\n7. Patients with significant coagulation abnormality;\n8. Patients with autoimmune diseases requiring treatment or with a history of syndrome requiring systemic use of steroid immunosuppressive agents, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;\n9. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with results interpretation, including uncontrolled diabetes, or pulmonary disease (a history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm);\n10. Evidence of central nervous system disease;\n11. Patients who received the live vaccine within 4 weeks of the start of the enrollment;\n12. Patients with hepatitis B (HBV HBsAg positive and HBV-DNA≥105), hepatitis C (HCV) infection (HCV antibody positive and HCV-RNA detectable); And subjects with other acquired or congenital immune deficiency diseases, including but not limited to hiv-infected;\n13. Pregnant or lactating women;\n14. Patients who have had previous organ transplants (except autologous hematopoietic stem cell transplants);\n15. Severe or uncontrolled infections;\n16. Patients with history of severe neurological or psychiatric illness, including dementia or epilepsy;\n17. Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results;\n18. Patients are unsuitable for the enrollment according to investigator's judgement.",{"count":138,"type":21},[97],"This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed\u002Frefractory peripheral T-cell lymphoma (r\u002Fr PTCL).",[128],[306,307,308,309,310],"relapsed\u002Frefractory peripheral T-cell lymphoma","PD-1 antibody","HDAC inhibitor","objective response rate","safety profile","2026-03-28",{"date":313,"type":38},"2026-04-02",{"date":315,"type":38},"2020-11-13",{"date":317,"type":21},"2026-12-31",{"name":319,"class":45},"Fudan University",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":329,"studyType":150,"phases":4,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":86},"100613766","real-world-outcomes-of-peripheral-t-cell-lymphoma-a-multicenter-retrospective-and-prospective-cohort-study-100613766","NCT07270861","Real-world Outcomes of Peripheral T-cell Lymphoma: A Multicenter Retrospective and Prospective Cohort Study","A Multicenter, Non-interventional, Two-cohort Study to Describe Real-world Treatment Patterns and Outcomes in Patients With Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* Age ≥18 years, with a histopathologic diagnosis of PTCL (any subtype per WHO 2016 classification of hematolymphoid neoplasms).\n* Cohort A: Patients diagnosed and treated at participating centers between 2010 and 2024.\n* Cohort B: Patients newly diagnosed from October 2025 onward.\n* Availability of basic diagnostic and treatment records .\n\nExclusion Criteria:\n\n* Indeterminate diagnosis or missing pathology report.\n* Patients diagnosed at an outside institution who did not receive their primary treatment and follow-up at a participating center.\n* Diagnoses of NK\u002FT-cell lymphoma or primary cutaneous T-cell lymphomas.",{"count":328,"type":21},3000,"5 Years","This study aims to characterize the epidemiology, clinicopathologic features, and survival outcomes of Chinese patients with PTCL; to develop and validate prognostic models to this population; to compare the real-world effectiveness and safety of alternative therapeutic strategies; to elucidate molecular mechanisms underlying treatment resistance and relapse; to identify actionable targets and predictive biomarkers.",[61],[333,334,335,336,337],"T-cell lymphoma","Retrospective cohort","Prospective cohort","Epidemiology","Biomarkers","2026-03-20",{"date":340,"type":38},"2026-03-24",{"date":342,"type":38},"2025-11-15",{"date":344,"type":21},"2035-12-31",{"name":319,"class":45},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":86},"100629155","t-cell-lymphoma--stratified-therapy-after-response-to-first-line-treatment-nr-100629155","NCT07470996","T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-NR","T-START-NR","Inclusion Criteria:\n\n1. At the time of ICF signing, the subject must be 18-70 years of age, inclusive, regardless of gender.\n2. The subject must have achieved Stable Disease (SD) or Progressive Disease (PD) as assessed per the Lugano 2014 classification criteria after first-line systemic standard therapy (CHOP or a CHOP-like regimen). This includes subjects who failed to achieve a response after at least 4 cycles of standard chemotherapy or who experienced disease progression during treatment.\n3. The subject must have a histologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are restricted to the following: Not Otherwise Specified (PTCL-NOS); ALK-negative Anaplastic Large Cell Lymphoma (ALK- ALCL); Follicular Helper T-cell Lymphoma or PTCL with a TFH phenotype (FTCL or PTCL-TFH). Additionally, they must meet the following condition:\n\n   Patients scheduled for allogeneic hematopoietic stem cell transplantation must have a suitable stem cell donor:\n\n   i. Related donors must be at least 5\u002F10 matched at HLA-A, -B, -C, -DQB1, and -DRB1.\n\n   ii. Unrelated donors must be at least 8\u002F10 matched at HLA-A, -B, -C, -DQB1, and -DRB1.\n4. Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 2.\n5. ECOG Performance Status score of 0 or 1, with no deterioration over the preceding two weeks.\n6. Life expectancy of at least 12 weeks.\n7. Adequate hepatic, renal, cardiac, and pulmonary function, defined as:\n\n   i. Hepatic: Serum total bilirubin ≤ 2 × ULN (or ≤ 3.0 × ULN in cases of Gilbert's syndrome or documented baseline liver involvement); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in cases of liver involvement).\n\n   ii. Renal: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin as calculated by the Cockcroft-Gault formula or measured.\n\n   iii. Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Multigated Acquisition (MUGA) scan or Echocardiography (ECHO).\n\n   iv. Baseline oxygen saturation on room air \\> 92%. v. Pulmonary: Diffusing capacity of the lungs for carbon monoxide (DLCO), corrected for hemoglobin, ≥ 40% and Forced Expiratory Volume in 1 second (FEV1) ≥ 50% of predicted.\n8. Voluntary participation in the clinical study; full understanding and awareness of the study and having signed the ICF; willingness and ability to comply with and complete all trial procedures.\n\nExclusion Criteria:\n\n1. Ann Arbor Stage I disease.\n2. History of any other malignancy within the past 5 years, except for locally cured malignancies after radical therapy (e.g., basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).\n3. Active infection, including:\n\n   * Known active or latent tuberculosis, indicated by a positive tuberculin (PPD) skin test (defined as induration \\>10 mm or per local clinical criteria) or radiographic findings on chest X-ray\u002FCT suggestive of active\u002Flatent TB.\n\n     * Known history of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS).\n\n       * Chronic active hepatitis B or C infection:\n\n         1. Hepatitis B virus (HBV) DNA-positive subjects are excluded; those with undetectable HBV-DNA are eligible. The upper limit of normal (ULN) for HBV-DNA is as defined by each participating center.\n         2. Hepatitis C virus (HCV) RNA-positive subjects are excluded; those with undetectable HCV-RNA are eligible. The ULN for HCV-RNA is as defined by each participating center.\n\n            * Active viral infections other than hepatitis B or C (e.g., herpes zoster, cytomegalovirus).\n\n              * Infection requiring intravenous antimicrobial therapy, evidenced by: hemodynamic instability related to infection, worsening or new infectious symptoms\u002Fsigns, new infectious foci on imaging, or persistent fever without localizing signs where infection cannot be ruled out.\n\n                * Positive serum DNA test for Epstein-Barr virus (EBV).\n4. Poorly controlled cardiac symptoms or diseases, including:\n\n   i. Heart failure \\> New York Heart Association (NYHA) Class II. ii. Unstable angina. iii. Myocardial infarction within the past year. iv. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n5. Pregnant or lactating women, and subjects of childbearing potential unwilling to use effective contraception.\n6. Patients with psychiatric disorders or those unable to provide informed consent.\n7. PTCL patients with central nervous system involvement.\n8. PTCL patients who have received prior PD-1\u002FPD-L1 inhibitor therapy.\n9. Any other condition that, in the investigator's judgment, renders the subject unsuitable for study participation.","70 Years",{"count":355,"type":21},58,"This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the alternative salvage regimens. It aims to evaluate the efficacy and safety of Allo-HSCT and alternative salvage regimens in the treatment of peripheral T-cell lymphoma that has achieved no response (NR) after first-line therapy. During the screening\u002Fbaseline period, informed consent will be obtained, and inclusion\u002Fexclusion criteria will be verified. Group assignment (Allo-HSCT vs. alternative salvage regimens) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 29 patients in each group. Data on demographics and medical history will be collected, and assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, and bone marrow pathology will be performed.",[27],[27,359,360,361],"no response","allogeneic hematopoietic stem cell transplantation","alternative salvage regimens","2026-03-10",{"date":364,"type":38},"2026-03-13",{"date":366,"type":38},"2025-10-01",{"date":368,"type":21},"2029-09-30",{"name":370,"class":45},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":378,"phases":4,"briefSummary":379,"conditions":380,"keywords":387,"overallStatus":389,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":392,"locationsCount":4},"100609534","karyopharm-expanded-access-program-for-selinexor-100609534","NCT07215832","Karyopharm Expanded Access Program for Selinexor","KEAP","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","KEAP is an expanded access program designed to provide selinexor to eligible participants outside of a clinical trial before the drug has been given marketing approval by the country's regulatory agency or the drug is commercially available in the country. Patients who do not qualify for an ongoing clinical trial but who might benefit from the investigational medicine may be eligible, provided they have exhausted all other available treatment options. Investigational medicines are provided to patients only through treating physicians who obtain the relevant approval on behalf of their patient from the relevant regulatory agency and follow all applicable safety-reporting regulations of the respective country.",[103,381,382,383,128,384,385,386],"Diffuse Large B-Cell Lymphoma (DLBCL)","Sarcoma","Neuroglioblastoma","Endometrial Cancer","Myelofibrosis","Other",[388],"selinexor","AVAILABLE","2026-02-26",{"date":288,"type":38},{"name":393,"class":113},"Karyopharm Therapeutics Inc",{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":407,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":416,"locationsCount":86},"100624832","phase-3-golidocitinib-versus-placebo-as-maintenance-therapy-in-ptcl-patients-with-response-crpr-after-first-line-chemotherapy-100624832","NCT07414758","Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR\u002FPR) After First-Line Chemotherapy","Golidocitinib Versus Placebo as Maintenance Therapy in Peripheral T-Cell Lymphoma Patients With Response (CR\u002FPR) After First-Line Chemotherapy: A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial","T-START-M1","Inclusion Criteria:\n\n* The subject must sign the informed consent form (ICF) in accordance with the relevant procedures described in the chapter, and be willing and able to comply with the requirements and restrictions listed in the ICF and this study protocol.\n* Age \\>18 years at the time of signing the ICF.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, with no deterioration within the last 2 weeks.\n* Histopathologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al., 2016). Eligible histological subtypes are limited to: PTCL-NOS (excluding primary cutaneous), ALK-negative ALCL, AITL, and follicular helper T-cell lymphoma or PTCL with TFH phenotype (FTCL or PTCL-TFH).\n* Subjects must have achieved a Complete Response (CR) or Partial Response (PR) as assessed by the Lugano 2014 criteria following first-line systemic standard therapy (limited to CHOP, BV-CHP, or CHOP-like regimens), and are either transplant-ineligible (age \\>65 years) or transplant-eligible (age ≤65 years) but have provided written refusal for transplantation. The time from the end of initial therapy to the planned first dose in this study must be ≤3 months.\n* Adequate bone marrow and organ function, as defined below:\n\n  1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL (≥1.0 × 10⁹\u002FL in case of bone marrow involvement by lymphoma). Subjects must not have used colony-stimulating factors within 7 days prior to study entry.\n  2. Platelet count ≥100 × 10⁹\u002FL (≥75 × 10⁹\u002FL in case of bone marrow involvement by lymphoma). Subjects must not have received transfusion or thrombopoietic agents within 7 days prior to study entry.\n  3. Hemoglobin ≥10 g\u002FdL.\n  4. Total bilirubin ≤2 × Upper Limit of Normal (ULN).\n  5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.\n  6. Serum creatinine ≤1.5 × ULN, OR calculated or measured creatinine clearance (Cockcroft-Gault formula) ≥50 mL\u002Fmin, OR a 24-hour urine collection demonstrating a creatinine clearance ≥50 mL\u002Fmin.\n* Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiogram (ECHO).\n* Voluntarily participate in the clinical study; fully understand and are informed about this study and sign the ICF; willing and able to follow and complete all trial procedures.\n\nExclusion Criteria:\n\n* Patients with clinical stage Ann Arbor I disease.\n* Any of the following treatment histories:\n\n  1. Received any investigational or antitumor drugs in another clinical trial within 30 days prior to the first study dose.\n  2. Has not discontinued cytotoxic chemotherapy agents for at least 21 days prior to the first study dose.\n  3. Received systemic corticosteroid therapy at a dose \\>10 mg prednisone equivalent per day within 1 week prior to the first study dose.\n  4. Underwent major surgery (excluding vascular access procedures) or experienced significant trauma within 4 weeks prior to the first study dose, or has planned surgery during the study.\n  5. Received antitumor monoclonal antibody therapy (including brentuximab vedotin) within 4 weeks; radiotherapy within 3 weeks; or other toxin\u002Fradioisotope-immunoconjugate therapy within 10 weeks prior to the first study dose.\n  6. Prior treatment with a JAK or STAT3 inhibitor.\n  7. Received antitumor immunotherapy (e.g., immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, anti-CTLA-4) within 28 days prior to the first study dose.\n  8. Received live-attenuated or viral vector vaccines within 28 days prior to the first study dose.\n  9. Current use (or inability to discontinue ≥1 week prior to the first dose) of vitamin K antagonists, antiplatelet agents, or anticoagulants.\n\nCurrent use (or inability to discontinue ≥1 week prior to the first dose) of medications, herbal supplements, or foods known to be potent inducers or inhibitors of CYP3A, or sensitive substrates of BCRP\u002FP-gp with a narrow therapeutic index (see Appendix F for guidance on potentially interacting concomitant medications).\n\n* History of other active malignancies within the past 5 years, except for curatively treated localized cancers such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n* Active infection, including:\n\n  1. Known active or latent tuberculosis, evidenced by a positive PPD skin test (\\>10 mm induration, or per local clinical criteria) or findings suggestive of active\u002Flatent TB on chest X-ray\u002FCT.\n  2. Known history of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS).\n  3. Chronic active Hepatitis B or C infection, except:\n\n  \u003C!-- -->\n\n  1. Subjects positive for HBsAg or HBcAb are eligible if HBV-DNA is undetectable.\n  2. Subjects positive for HCV antibody are eligible if HCV-RNA is undetectable. (The ULN for HBV-DNA and HCV-RNA assays is defined per each center's laboratory standards.) (d) Other active viral infections (e.g., herpes zoster), cytomegalovirus (CMV), or Epstein-Barr virus (EBV) infection, excluding Hepatitis B and C.\n\nActive infection requiring intravenous antimicrobial therapy, characterized by hemodynamic instability, worsening\u002Fnew infectious symptoms\u002Fsigns, new infectious foci on imaging, or persistent fever without other explanation.\n\n* Poorly controlled or clinically significant cardiac disease, such as:\n\n  i. Heart failure \\> New York Heart Association (NYHA) class II. ii. Unstable angina. iii. Myocardial infarction within the past year. iv. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n* Pregnant or lactating women, or subjects of childbearing potential unwilling to use effective contraception.\n* History of severe psychiatric disorders or inability to provide informed consent.\n* Subjects with refractory nausea, vomiting, or chronic gastrointestinal diseases that may impair drug absorption.\n* Significant impairment of pulmonary function, defined as forced expiratory volume in 1 second (FEV1) and diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C60% of predicted.\n* Presence of unresolved drug-related toxicities \\> Grade 1 per CTCAE (except for alopecia) prior to the first study dose.\n* Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in this study.",{"count":403,"type":21},68,[125],"This is a multicenter, randomized, double-blind, phase III clinical study comprising two arms: a golidocitinib group and a placebo group. The study aimed to evaluate the antitumor efficacy and safety of golidocitinib in patients who had achieved a response after first-line systemic therapy and were ineligible for hematopoietic stem cell transplantation. The investigational intervention consisted of either golidocitinib or matching placebo capsules, administered orally at a planned dose of 150 mg once every other day. Treatment continued until disease progression, initiation of new anti-lymphoma therapy, withdrawal of informed consent, death, or investigator decision to discontinue the study, whichever occurred first. The study treatment period was divided into 28-day cycles starting from the first dose. Efficacy and safety assessments were performed at specified time points within each cycle. The maximum duration of treatment was 2 years. A total of 136 patients were enrolled, with 68 patients assigned to the golidocitinib treatment group and 68 to the placebo control group. Data on demographics and medical history were collected, and assessments including vital signs, physical examination, and PET-CT were conducted.",[27],[27,408,409],"golidocitinib","interventional","2026-02-20",{"date":412,"type":38},"2026-02-24",{"date":414,"type":21},"2026-02-15",{"date":368,"type":21},{"name":370,"class":45},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":86},"100564508","phase-2-a-phase-ii-single-center-single-arm-study-evaluating-the-safety-and-efficacy-of-golidocitinib-in-the-management-of-newly-diagnosed-peripheral-t-cell-lymphoma-patients-golden-study-and-correlative-study-100564508","NCT06630091","A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study","Inclusion Criteria:\n\n* Provision of a signed and dated, written informed consent form prior to any study specific procedures, sampling, and analyses.\n* Submission of the tumor block or unstained slides from an excisional or core biopsy from nodal or extra-nodal lymphoma tissue (archived or newly obtained sample) is required for retrospective central confirmation of tumor histological subtype.\n* Aged ≥ 18 years old.\n* Participants must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks.\n* Predicted life expectancy ≥ 12 weeks.\n* Participants must have histologically confirmed peripheral T-cell lymphoma by MD Anderson pathology review according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms53. Eligible histological subtypes are restricted to the following:\n\n  * PTCL, not otherwise specified (PTCL, NOS) (the proportion of PTCL-NOS subtype will not exceed 30% of all enrolled)\n  * Angioimmunoblastic T-cell lymphoma (AITL)\n  * Follicular T cell lymphoma\n  * PTCL with T follicular helper (TFH) phenotype\n* Participants must have measurable disease according to the 2014 Lugano classification, which is defined as lymphomatous nodes, nodal masses, or other lymphomatous lesions are measurable in two diameters (longest diameter \\[LDi\\] and shortest diameter perpendicular to the LDi \\[SDi\\]) on CT scans, and also with LDi as below:\n\n  * A measurable node must have an LDi greater than 1.5 cm.\n  * A measurable extranodal lesion should have an LDi greater than 1.0 cm.\n* Participants must be treatment naïve with no prior systemic treatment for T-cell lymphoma (i.e., PTCL). Participants could be transplant eligible or ineligible upon their entries to this study.\n* Adequate bone marrow reserve and organ system functions, as outlined below:\n\n  * Absolute neutrophil count (ANC) ≥ 1 ×109\u002FL (≥0.5 ×109\u002FL if documented bone marrow involvement with lymphoma) independent of growth factor support within 7 days of study entry.\n  * Platelets ≥ 75 × 109\u002FL (or ≥ 50 × 109\u002FL if documented bone marrow involvement with lymphoma) independent of growth factor support or transfusion within 7 days of study entry.\n  * Hemoglobin ≥ 8 g\u002FdL\n  * Total bilirubin ≤ 1.5 ×ULN if no liver involvement or ≤ 3 ×ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver involvement.\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 ×ULN if with document hepatic involvement with lymphoma.\n  * Creatinine ≤ 1.5 × ULN, OR calculated or measured creatinine clearance ≥ 50 mL\u002Fmin as calculated by the Cockcroft-Gault method, or 24-hour measured urine creatinine clearance ≥ 50 mL\u002Fmin.\n* LVEF ≥ 50% assessed by ECHO or MUGA.\n* Participants should have the ability and willingness to comply with the study and follow up.\n* The effects of golidocitinib on the developing human fetus are unknown. For this reason and because JAK1 inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Women treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of golidocitinib administration. If female patients wish to mother children, they should be advised to arrange for freezing of eggs prior to the start of study treatment.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of golidocitinib administration. Men must refrain from donating sperm during their participation in the study and at least for 6 months after the last treatment. If male patients wish to father children, they should be advised to arrange for freezing of sperm samples prior to the start of study treatment.\n\nExclusion Criteria:\n\nParticipants must not enter the study if any of the following exclusion criteria are fulfilled:\n\n* Intervention with any of the following:\n\n  * Any investigational anti-cancer agents or anti-cancer study drugs from a previous clinical study.\n  * Any cytotoxic chemotherapy from a previous treatment regimen.\n  * Corticosteroids at dosages equivalent to prednisone \\> 40 mg\u002Fday within 7 days of the start of the study treatment.\n  * Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.\n  * Prior treatment with a JAK or STAT3 inhibitor.\n  * Prior treatment with any onco-immunotherapy in 28 days prior to first dosing of golidocitinib (e.g., immune checkpoint inhibitors PD-1, PD-L1, CTLA4).\n  * Live vaccines within 28 days prior to first dose.\n  * Participants currently receiving (or unable to stop use at least 1 week prior to receiving the first dose) medications or herbal supplements known to be Potent inhibitors or inducers of CYP3A .\n* Central nervous system or leptomeningeal lymphoma given the lack of evidence of CNS penetrance of the investigational drug.\n* Participants with severely decreased lung function (i.e. any parameter of FEV1, and DLCO \\\u003C 60% of predicted value). Past medical history of pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n* Participants with disease condition which requires the treatment of immunosuppressants, biologics, or NSAIDs (non-steroid anti-inflammatory drugs).\n* Active infections including\n\n  * History of known active tuberculosis (TB).\n  * Known infection with human immunodeficiency virus (HIV).\n  * Known active hepatitis B or hepatitis C infection as follows\n* Active viral infections (i.e., zoster) other than hepatitis B or C.\n\n  o Infections requiring oral or intravenous antimicrobial therapy or interferon within 14 days.\n* Any of the following cardiac criteria:\n\n  * Congestive heart failure (CHF) per New York Heart Association (NYHA) classification \\> Class II .\n  * Clinically significant valvular diseases, hypertrophic or constrictive cardiomyopathy.\n  * Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval \\> 250 msec.\n  * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\n  * Acute Myocardial Infarction (AMI) within 6 months prior to starting treatment, unstable angina or new-onset angina.\n  * Participants with heart transplant.\n  * Mean resting corrected QTcF interval \\>450 ms on screening electrocardiogram (ECG).\n  * Participants with factors that increase the risk of QT prolongation or arrhythmic events (e.g., congenital long QT syndrome, any concomitant medication known to prolong the QT interval or family history of long QT interval syndrome or unexplained sudden death under 40 years of age in first degree relatives).\n  * Participants with acute thrombotic diseases such as pulmonary embolism (PE) and deep venous thrombosis (DVT) within 90 days. Participants with remote history (\\>6 months) of provoked PE or DVT (e.g., line-associated DVT; DVT or PE after surgical procedure), and participants on appropriate anticoagulation for 90 or more days from the event will not be excluded.\n* Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.\n* Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of golidocitinib.\n* History of hypersensitivity to active or inactive excipients of golidocitinib or drugs with a similar chemical structure or class.\n* As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses. Screening for chronic conditions is not required.\n* Concurrent conditions that in the investigator's opinion would jeopardize compliance with the protocol.\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n* All participants must avoid concomitant use of medications, herbal supplements and\u002For ingestions of foods with known potent inducer\u002Finhibitory effects on CYP3A activity whenever feasible. Such drugs must have been discontinued for an appropriate period before they enter screening and for a period after the last dose of golidocitinib. Guidance on medications to avoid, medications that require close monitoring and on washout periods.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because golidocitinib is a JAK1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with golidocitinib, breastfeeding should be discontinued if the mother is treated with golidocitinib. These potential risks may also apply to other agents used in this study.",{"count":149,"type":21},[97],"To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.",[27],"2026-02-13",{"date":429,"type":38},"2026-02-17",{"date":431,"type":38},"2025-02-21",{"date":433,"type":21},"2029-07-05",{"name":435,"class":45},"M.D. Anderson Cancer Center",{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":353,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":448,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":86},"100622899","phase-2-a-clinical-trial-of-cidabenamine-plus-azacitidine-to-prevent-post-transplant-progression-in-high-risk-peripheral-t-cell-lymphoma-100622899","NCT07389616","A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma","A Clinical Study of Cidabenamine Combined With Azacitidine for Preventing Progression in High-Risk Peripheral T-Cell Lymphoma After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Aged 18 to 70 years, male or female.\n2. Diagnosis of peripheral T-cell lymphoma (PTCL) according to the 2022 WHO criteria, including pathological subtypes such as PTCL not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL), and angioimmunoblastic T-cell lymphoma (AITL), but excluding hepatosplenic T-cell lymphoma; and meeting at least one of the following high-risk criteria:\n\n   ① Stable Disease (SD) at the time of transplantation;\n\n   ② Relapse after autologous hematopoietic stem cell transplantation (any disease status);\n\n   ③ ≥ Partial Response 1 (PR1).\n3. Underwent allogeneic peripheral blood hematopoietic stem cell transplantation for PTCL, with no restriction on donor type.\n4. Presence of complete donor chimerism in the bone marrow (T-cell chimerism \\>95%).\n5. ECOG performance status of 0 or 1.\n6. Hematological function meeting the following requirements:\n\n   ① Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL;\n\n   ② Platelet count (PLT) ≥ 50 × 10⁹\u002FL.\n7. Patients must have the ability to understand and be willing to participate in the study and must provide signed informed consent.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to hypomethylating agents or Cidabenamine.\n2. Presence of grade II or higher active acute Graft-versus-Host Disease (GVHD).\n3. Presence of moderate or more severe chronic GVHD.\n4. Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack (within 3 months prior to screening), myocardial infarction (within 3 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] Class ≥ III), status post pacemaker implantation, severe arrhythmia requiring pharmacological treatment, hepatic, renal, or metabolic disease, or pulmonary hypertension.\n5. Active, uncontrolled infection, evidenced by any of the following: infection-related hemodynamic instability, worsening or new-onset infectious symptoms\u002Fsigns, radiologic evidence of a new infectious focus, or persistent fever without localizing symptoms\u002Fsigns where infection cannot be ruled out.\n6. Known HIV infection.\n7. Active Hepatitis B (HBV) or active Hepatitis C (HCV) requiring antiviral therapy.\n8. History of an autoimmune disease.\n9. Pregnant or lactating women.\n10. Concurrent participation in another interventional clinical trial and receiving other investigational drugs.",{"count":444,"type":21},40,[97,125],"This study is a single-center, single-arm, prospective, phase II clinical trial designed to evaluate the efficacy and safety of Cidabenamine combined with Azacitidine as maintenance therapy following allogeneic peripheral blood hematopoietic stem cell transplantation in patients with high-risk peripheral T-cell lymphoma.During the screening\u002Fbaseline period, informed consent will be obtained, and inclusion\u002Fexclusion criteria will be verified. The study plans to enroll 40 patients in each group. Enrolled patients will undergo demographic and medical history data collection, along with assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, lymphoid gene rearrangement, and bone marrow pathology.",[27],[27,449,450,451],"Cidabenamine","high-risk","Azacitidine","2026-01-29",{"date":454,"type":38},"2026-02-05",{"date":456,"type":21},"2026-02-01",{"date":458,"type":21},"2029-08-01",{"name":370,"class":45},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":475,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":7},"100392493","phase-1-evaluate-the-safety-and-clinical-activity-of-hh2853-100392493","NCT04390737","Evaluate the Safety and Clinical Activity of HH2853","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients With Relapsed\u002FRefractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors","Inclusion criteria:\n\n1. Provided signed written informed consent prior to initiation of any study-related procedures;\n2. Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age);\n3. Tumor type criteria:\n\nThe specific requirements for specific subtypes of recurrent\u002Frefractory non Hodgkin's lymphoma (NHL) confirmed by histology are as follows:\n\nHistologically confirmed follicular lymphoma (FL) that has been treated with at least two lines of systemic therapy (at least one regimen based on anti-CD20 monoclonal antibodies) according to GELF criteria or as determined by researchers (Grade 1-3a); Relapsed\u002Frefractory diffuse large B-cell lymphoma - non-specific (DLBCL NOS, 2016 World Health Organization Lymphoma Classification) that has received at least two treatment regimens in the past (at least one with CD20 monoclonal antibody as the main treatment, with a maximum number of treatment lines\\\u003C5), and is not a candidate for salvage treatment or autologous\u002Fallogeneic stem cell transplantation.\n\nRelapsed\u002Frefractory clinicopathologically documented PTCL with at least 1 line of prior systemic treatment (maximum \\\u003C5 lines). Solid tumors that meet the following criteria:\n\n1. Histologically or cytologically documented advanced recurrent or metastatic solid tumor.\n2. Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target lesions by RECIST v1.1 in at least 1 site. (Lesions that have been treated with radiotherapy or other local treatment are generally considered unmeasurable unless there is definite progression of the lesion.)\n3. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. One of the following criteria should be met.\n\nPatients must experience at least one prior standard therapy. Disease progression occurred on or after last line of therapy, or intolerant to last line of therapy (maximum ≤3 lines, Patients without treatment options available known to provide clinical benefit are also eligible upon agreement from investigator and sponsor) There is no approved therapy, or for which standard therapy is unsuitable or refused by patients after being fully informed.\n\nFor epithelioid sarcoma in Phase I and Phase II cohort 2:\n\n1. Confirmed by local histology or cytology\n2. Patients with unresectable locally delayed or metastatic epithelioid sarcoma who have undergone treatment (including those who have failed treatment and developed intolerable toxicity).\n\nFor solid tumors in Phase I and Phase II queue 3:\n\n1. Confirmed by local pathology as advanced recurrent or metastatic solid tumor.\n2. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1; 5. Availability of archival tissue within three years 6. Relapsed\u002FRefractory FL, Epithelioid sarcoma, relapsed\u002Frefractory PTCL, other relapsed\u002Frefractory non-Hodgkin's lymphomas with EZH2 mutation, and advanced solid tumors with specific genetic alterations, including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or\u002Fand SMARCA4 mutation 7. Predicted life expectancy of ≥ 3 months; 8. Patient must meet the following laboratory values: 1.Serum total Bilirubin ≤ 1.5 x ULN or ≤ 3.0 mg\u002FdL for patients with Gilbert's syndrome 2.AST\u002FSGOT and ALT\u002FSGPT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present 3.24-hour creatinine clearance (calculated\\* or measured value\\*\\*)≥ 50 mL\u002Fmin 4.Platelets ≥ 1 x LLN (no Platelet transfusion for 7 days prior to screening) 5.Hemoglobin (Hgb) ≥ 9 g\u002FdL 6.Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\\^9\u002FL 7.Adequate coagulation function: International normalized ratio (INR) \\\u003C1.3 (or \\\u003C3.0 on anticoagulants) 9. Measurable lesion\n\nExclusion Criteria:\n\n1. Any cancer-directed therapy within 28 days or five half-lives prior to first dose; Small molecule anticancer therapy within 2 weeks or five half-lives; Local radiotherapy within 14 days of first dose.\n2. Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.\n3. Patients with prior transplant are excluded;\n4. Major surgery within 4 weeks prior to first dose;\n5. A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose;\n6. HIV (human immunodeficiency virus) infection, active hepatitis B or hepatitis C patients (HBsAg positive patients with HBV (hepatitis B virus) DNA ≥ 10\\^3 copies or ≥ 200 IU\u002FmL; HCV antibody test results are positive, and HCV (hepatitis C virus) RNA PCR test results are positive).\n7. Concomitant malignancies or previous malignancies\n8. Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited except low molecular weight heparin and direct oral anticoagulants.\n9. Any toxicities from prior treatment that have not recovered to ≤ CTCAE Grade 1\n10. There were ≥ 3 lesions with punctate bleeding, any active bleeding, intratumoral bleeding, known bleeding tendencies, or treatment with antiplatelet\u002Fantithrombotic drugs.\n11. Gastrointestinal condition which could impair absorption of study medication;\n12. Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol;\n13. Cardiac exclusion criteria:\n\n1.History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 3 months prior to first dose of study drug; 2.Fridericia's corrected QT interval (QTcF) \\> 450 ms (for male) and \\> 470 ms (for female) on ECG conducted during screening; 3.Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death; 4.History or current evidence of serious uncontrolled ventricular arrhythmias; 5.Symptomatic congestive heart failure (Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system) within the previous 3 months; 6.Left ventricular ejection fraction (LVEF) \\\u003C 50%; 14. Any evidence of serious active infections requiring antibiotics; 15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or their excipients; 16. Pregnant or breast-feeding female; 17. Contraception: 18. Other serious illness or medical conditions at the Investigator's discretion, that may influence study results 19. Previously received treatment with EZH2 or EZH1\u002F2 inhibitors. 20. Grade 3b FL or evidence of transformation to invasive lymphoma",{"count":468,"type":21},254,[24,97],"This is an open-label, multicenter, first-in-human phase I\u002FII study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.",[472,473,27,474],"FL Lymphoma","Epithelioid Sarcoma","Advanced Solid Tumor",[476,477,478,479],"Phase I\u002FII","HH2853","PRC2","EZH 1\u002F2 inhibitor","2026-01-28",{"date":482,"type":38},"2026-01-30",{"date":484,"type":38},"2020-09-08",{"date":486,"type":21},"2028-12-31",{"name":488,"class":113},"Haihe Biopharma Co., Ltd.",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":496,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":501,"overallStatus":507,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":4},"100606839","phase-2-a-study-of-bosmolisib-br101801-in-participants-with-rr-ptcl-100606839","NCT07180771","A Study of Bosmolisib (BR101801) in Participants With R\u002FR PTCL.","A Phase II, Single-arm, Multicenter, Open Label Study to Evaluate Efficacy and Safety of BR101801 Monotherapy in Relapsed\u002FRefractory Peripheral T-cell Lymphoma Patients","Key Inclusion Criteria:\n\n1. The ECOG performance status ≤ 2.\n2. Life expectancy more than 3 months.\n3. Patients with relapsed and\u002For refractory to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification\n\n   * Peripheral T-cell lymphoma, not otherwise specified\n   * Nodal TFH cell lymphoma, angioimmunoblastic-type\n   * Nodal TFH cell lymphoma, follicular-type\n   * Nodal TFH cell lymphoma, NOS\n4. Patients currently requiring systemic therapy at the investigator's discretion.\n5. Patients with a lesion measuring 1.5 cm or more in its longest transverse diameter, as determined by CT, PET\u002FCT or MRI scans according to the 2014 Lugano criteria.\n\nKey Exclusion Criteria:\n\n1. The presence of overt leptomeningeal or active central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks.\n2. Impaired cardiac function or clinically significant cardiac disease.\n3. Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia\u002Fpneumonitis.\n4. For patients with lymphoma:\n\n   * Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon \\[INF\\], and toxin immunoconjugates) or any experimental therapy within 3 weeks or 5 half lives, whichever is shorter, before the first dose of study treatment.\n   * Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.\n   * Unconjugated monoclonal antibody therapies \\\u003C 6 weeks before the first dose of study treatment.\n5. Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (\\>20 mg\u002Fday prednisone or equivalent).","19 Years",{"count":190,"type":21},[97],"The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).",[27],[502,503,504,505,506],"PTCL","Bosmolisib","BR101801","PI3K inhibitor","DNA-PK","NOT_YET_RECRUITING","2026-01-27",{"date":480,"type":38},{"date":511,"type":21},"2026-02",{"date":513,"type":21},"2027-09",{"name":515,"class":113},"Boryung Pharmaceutical Co., Ltd",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":353,"enrollmentInfo":523,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":535,"leadSponsor":536,"locationsCount":86},"100620147","t-cell-lymphoma--stratified-therapy-after-response-to-first-line-treatment-cr-100620147","NCT07353840","T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-CR","T-START-CR","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive) at the time of signing the Informed Consent Form (ICF).\n2. ECOG Performance Status score of 0 or 1, with no deterioration over the preceding two weeks.\n3. Life expectancy of at least 12 weeks.\n4. Histologically confirmed diagnosis of PTCL by the central study site according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are restricted to the following:\n\n   1. Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)\n   2. Anaplastic large cell lymphoma, ALK-negative (ALK- ALCL)\n   3. Follicular helper T-cell lymphoma or PTCL with a TFH phenotype (FTCL or PTCL-TFH)\n5. Must have achieved a Complete Response (CR) as assessed per the Lugano 2014 classification criteria for lymphoma response after first-line systemic standard therapy (CHOP or a CHOP-like regimen).\n6. Adequate hepatic and renal function, defined as:\n\n   1. Hepatic: Serum total bilirubin ≤ 2 × ULN (or ≤ 3.0 × ULN in cases of Gilbert's syndrome or documented baseline liver involvement); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in cases of liver involvement).\n   2. Renal: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin as calculated by the Cockcroft-Gault formula or measured.\n7. Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Multigated Acquisition (MUGA) scan or Echocardiography (ECHO).\n8. Voluntary participation in the clinical study; full understanding and awareness of the study, and having signed the ICF; willingness and ability to comply with and complete all trial procedures.\n\nExclusion Criteria:\n\n1.Ann Arbor Stage I disease. 2.History of any other malignancy within the past 5 years, except for locally curable malignancies that have been treated with curative intent (e.g., basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).\n\n3.Active infection, including:\n\n1. Known active or latent tuberculosis, evidenced by a positive tuberculin (PPD) skin test (where a positive result is defined as an induration \\>10 mm or per local clinical standards) or findings suggestive of active\u002Flatent TB on chest X-ray\u002FCT.\n2. Known history of Human Immunodeficiency Virus (HIV) infection and\u002For AIDS.\n3. Chronic active hepatitis B or C infection:\n\n   1. For hepatitis B virus (HBV): Subjects who are HBV DNA positive are excluded. Subjects with undetectable HBV DNA levels are eligible. The upper limit of normal (ULN) for HBV DNA is determined by the local laboratory at each center.\n   2. For hepatitis C virus (HCV): Subjects who are HCV RNA positive are excluded. Subjects with undetectable HCV RNA are eligible. The ULN for HCV RNA is determined by the local laboratory at each center.\n4. Active viral infections other than hepatitis B or C (e.g., herpes zoster), or cytomegalovirus (CMV) infection.\n5. Infection requiring intravenous antimicrobial therapy: evidenced by infection-related hemodynamic instability, worsening or new-onset infectious symptoms\u002Fsigns, radiologic evidence of a new infectious focus, or persistent fever without localizing signs where infection cannot be ruled out.\n6. Positive serological test for Epstein-Barr virus (EBV). 4.Poorly controlled cardiac symptoms or diseases, such as: i. Heart failure \\> New York Heart Association (NYHA) Class II. ii. Unstable angina. iii. Myocardial infarction within the past year. iv. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n\n5.Pregnant or lactating women, and subjects of childbearing potential unwilling to employ effective contraception.\n\n6.Patients with psychiatric disorders or those unable to provide informed consent.\n\n7.Any other condition which, in the investigator's judgment, makes the subject unsuitable for participation in this study",{"count":524,"type":21},160,"This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the observation group and the autologous hematopoietic stem cell transplantation group (Auto-HSCT). It aims to evaluate the efficacy and safety of Auto-HSCT and observation in the treatment of peripheral T-cell lymphoma that has achieved complete response (CR) after first-line therapy. During the screening\u002Fbaseline period, informed consent will be obtained, and inclusion\u002Fexclusion criteria will be verified. Group assignment (Observation vs. Auto-HSCT) will be determined taking into account the patient's preference. The study plans to enroll 80 patients in each group. Data on demographics and medical history will be collected, and assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, and bone marrow pathology will be performed.",[27],[27,528,529,530],"autologous hematopoietic stem cell transplantation","observation","complete response","2026-01-12",{"date":533,"type":38},"2026-01-20",{"date":533,"type":21},{"date":368,"type":21},{"name":370,"class":45},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":555,"locationsCount":86},"100600147","phase-1-golidocitinib-combined-with-mitoxantrone-hydrochloride-liposome-or-chidamide-in-the-treatment-of-relapsed-or-refractory-peripheral-t-cell-lymphoma-100600147","NCT07093710","Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma","The Safety and Efficacy of Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Prospective, Multicenter, Open-label, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;\n* Diagnosed with PTCL according to the 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center\n* Using the Lugano 2014 lymphoma efficacy evaluation criteria, the patient must have at least one measurable or evaluable lesion\n* Age ≥ 18 years\n* Expected survival greater than 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Accompanied by hemophagocytic lymphohistiocytosis (HLH)\n* Lymphoma involvement in the central nervous system or meninges\n* Active infections\n* Uncontrolled clinical cardiac symptoms or diseases\n* Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.\n* Currently using vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable to stop them within one week prior to the start of the study treatment).\n* History of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS).\n* Patients with mental disorders or those unable to provide informed consent",{"count":545,"type":21},101,[24,97],"This is a prospective, multicenter, open-label, phase Ib\u002FII clinical study to evaluate the safety and efficacy of golidocitinib combined with mitoxantrone hydrochloride liposome or chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma",[27],"2025-12-26",{"date":551,"type":38},"2025-12-31",{"date":553,"type":38},"2025-08-27",{"date":458,"type":21},{"name":556,"class":45},"Sun Yat-sen University",{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":353,"enrollmentInfo":565,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":567,"conditions":568,"keywords":569,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":576,"leadSponsor":577,"locationsCount":86},"100612403","allo-hsct-vs-auto-hsct-for-ptcl-patients-with-pr-after-first-line-systemic-therapy--a-prospective-multicenter-cohort-study-t-start-pr-100612403","NCT07253129","Allo-HSCT Vs. Auto-HSCT for PTCL Patients With PR After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study-(T-START-PR)","Allogeneic Hematopoietic Stem Cell Transplantation Versus Autologous Hematopoietic Stem Cell Transplantation for Peripheral T-cell Lymphoma Patients With Partial Remission After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study(T-START-PR)","T-START-PR","Inclusion Criteria:\n\n1. Age \\& Sex:\n\n   Males or females aged 18 to 70 years (inclusive).\n2. ECOG performance status score of 0 to 1, with no deterioration within the last two weeks.\n3. Expected survival period greater than 12 weeks.\n4. Patients must have a histopathological confirmation of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are limited to the following:\n\n   * Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)\n   * Anaplastic large cell lymphoma, ALK-negative (ALK-ALCL)\n   * Follicular helper T-cell lymphoma or PTCL with TFH phenotype (FTCL or PTCL-TFH)\n\n   Patients undergoing allogeneic hematopoietic stem cell transplantation must have a suitable stem cell donor:\n\n   (i) Related donors must be at least 5\u002F10 matched for HLA-A, -B, -C, -DQB1, and -DRB1.\n\n   (ii) Unrelated donors must be at least 8\u002F10 matched for HLA-A, -B, -C, -DQB1, and -DRB1.\n5. Patients must have achieved a partial response (PR) as per the Lugano 2014 response criteria for lymphoma after six cycles of CHOP, BV-CHP or CHOP-like chemotherapy.\n6. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≤ 2.\n7. Adequate hepatic, renal, cardiac, and pulmonary function, defined as follows:\n\n   1. Hepatic function: Serum total bilirubin ≤ 2 × upper limit of normal (ULN) (≤ 3.0 × ULN in cases of Gilbert's syndrome or baseline hepatic involvement); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5.0 × ULN in cases of hepatic involvement).\n   2. Renal function: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin as calculated or measured by the Cockcroft-Gault method.\n   3. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition (MUGA) scan or echocardiography (ECHO).\n   4. Baseline oxygen saturation \\> 92%.\n   5. Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) (hemoglobin-corrected) ≥ 40% and forced expiratory volume in 1 second (FEV1) ≥ 50%.\n\nExclusion Criteria:\n\n1. Ann Arbor clinical stage I disease.\n2. History of malignancy within the past 5 years, except for locally curable malignancies that have been treated with curative intent (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).\n3. Active infection, including:\n\n   1. Known active or latent tuberculosis, evidenced by a positive tuberculin (PPD) skin test (induration \\>10 mm or per local criteria for a positive result) or radiographic findings suggestive of active\u002Flatent TB on chest X-ray\u002FCT.\n   2. Known history of infection with Human Immunodeficiency Virus (HIV) and\u002For AIDS.\n   3. Chronic active hepatitis B or hepatitis C infection:\n\n   \u003C!-- -->\n\n   1. Patients positive for hepatitis B virus (HBV) DNA are excluded; however, those with undetectable HBV DNA levels are eligible. The upper limit of normal (ULN) for HBV DNA shall be based on the reference values of each participating center.\n   2. Patients positive for hepatitis C virus (HCV) RNA are excluded; however, those with undetectable HCV RNA are eligible. The ULN for HCV RNA shall be based on the reference values of each participating center.\n\n   (d) Active viral infections other than hepatitis B or hepatitis C (e.g., herpes zoster, cytomegalovirus).\n\n   (e) Infection requiring intravenous antimicrobial therapy, associated with hemodynamic instability, worsening or new onset of infectious signs\u002Fsymptoms, or new infectious foci on imaging; or persistent fever without localizing signs that cannot rule out infection.\n\n   (f) Positive serum DNA test for Epstein-Barr virus (EBV).\n4. Poorly controlled cardiac symptoms or disease, such as:\n\n   i. Heart failure greater than New York Heart Association (NYHA) class II. ii. Unstable angina. iii. Myocardial infarction within the past year. iv. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n5. Pregnant or lactating women, and subjects of childbearing potential unwilling to use effective contraception.\n6. Psychiatric illness or individuals unable to provide informed consent.\n7. PTCL patients with central nervous system involvement.\n8. PTCL patients who have previously received PD-1 inhibitor therapy.\n9. Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation in this study.",{"count":566,"type":21},88,"This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the autologous hematopoietic stem cell transplantation group (Auto-HSCT). It aims to evaluate the efficacy and safety of Auto-HSCT and Allo-HSCT in the treatment of peripheral T-cell lymphoma that has achieved partial response (PR) after first-line therapy. During the screening\u002Fbaseline period, informed consent will be obtained, and inclusion\u002Fexclusion criteria will be verified. Group assignment (Allo-HSCT vs. Auto-HSCT) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 44 patients in the allogeneic hematopoietic stem cell transplantation group, while all concurrent patients undergoing autologous stem cell transplantation will be included in the other group for inverse probability weighting analysis. Data on demographics and medical history will be collected, and assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, and bone marrow pathology will be performed.",[27],[570,360,528,571],"peripheral T cell lymphoma","partial response","2025-12-22",{"date":574,"type":38},"2025-12-23",{"date":551,"type":21},{"date":368,"type":21},{"name":370,"class":45},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":585,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":86},"100614763","phase-2-amping-up-with-pemjak-100614763","NCT07283822","Amping up With PemJAK","A Phase II Trial of JAK Inhibitor Added to Immunotherapy for Treatment of Relapsed\u002FRefractory T-cell Lymphoma and 9p Amplified Lymphomas","Inclusion Criteria:\n\n* (1) Histologically confirmed relapsed\u002Frefractory HL, PMBCL, GZL, and TCL including the below subtypes:\n\n  * Arm 1: PTCL\n\n    * Nodal PTCL Peripheral T-cell Lymphoma- Not Otherwise Specified (PTCL-NOS)\n    * Anaplastic Large Cell Lymphoma (ALCL) T-follicular Helper Lymphomas (TFH) and its subtypes including angioimmunoblastic T-cell Lymphoma (AITL)\n    * Extranodal NK\u002FT-cell lymphoma\n    * Subcutaneous Panniculitis T-Cell Lymphoma\n  * Arm 2: CTCL\n\n    * Mycosis Fungoides\n    * Sezary Syndrome\n  * Arm 3: exploratory cohort\n\n    * Classic HL\n    * PMBCL\n    * GZL\n* (2) All patients must have received at least one-line systemic therapy.\n\n  * Patients with systemic ALCL must have received prior CD30-directed therapy.\n  * Other PTCL subtypes that express CD30 (\\>10%), must have received prior CD30-directed therapy.\n  * Special Consideration for CTCL in Arm 2:\n\n    * Systemic therapies including bexarotene (targretin) are permissible up to 2 weeks prior to enrollment.\n    * Skin directed therapies including light therapy\u002Fphototherapy, extracorporeal photopheresis (ECP), topical steroids, or mechlorethamine (valchlor) gel are NOT considered a systemic line of therapy when given alone.\n    * Treatment with radiation, phototherapy, histone deacetylase inhibitor, retinoids, interferons, therapeutic doses of systemic corticosteroids, or denileukin diftitox (18 µg\u002Fkg\u002Fday) up to 2 weeks prior to enrollment is allowed.\n    * Treatment with alemutuzumab up to 8 weeks prior to enrollment is permissible.\n* (3) Patients must not have had chemotherapy or immunotherapy within 2 weeks prior to entering the study and must have recovered from adverse events (to grade 1 or less)\n* (4) Anti PD-1\u002FPDL-1is permissible up to two weeks prior to enrollment.\n* (5) Age ≥ 18\n* (6) Participants must have measurable disease, as defined in the protocol\n\n  * Patients must have a PET-CT scan performed within ≤4 weeks.\n  * Contrast enhanced CT scan or MRI of the neck, chest, abdomen, pelvis is permissible, however; PET is preferred.\n* (7) Patients cannot have active central nervous system (CNS) disease. Patients that have been treated and asymptomatic are allowed on study.\n* (8) All participants must be screened for chronic hepatitis B virus (HBV) with hepatitis B viral load and serologies (core antibody, surface antigen, and surface antibody) within 30 days prior to enrollment.\n\n  * Patients with positive Hep B core will need to be on HBV prophylaxis\n  * Patients with positive Hep B core will need to be on HBV prophylaxis.\n* (9) Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. If actively on treatment, HCV viral load mut be undetectable 30 days prior to enrollment.\n* (10) Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test (must be within 26 weeks prior to enrollment).\n* (11) Organ function as assessed by laboratory testing and Eastern Cooperate Oncology Group (ECOG) performance status 0-2 and or a Karnofsky performance score of equal or greater to 50 (see Section 20.1.1, Appendix A) for receipt of ruxolitinib and pembrolizumab.\n\n  * Absolute Neutrophil Count ≥ 1000\u002FμL (not growth factor independent)\n  * Platelets ≥ 70,000\u002FμL (or ≥50,000\u002Fmm3 if known bone marrow involvement with dose modifications allowed. See protocol for specific instructions for dose modifications).\n  * Baseline hemoglobin level ≥ 8 g\u002FdL (irrespective of bone marrow involvement).\n  * Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula\n  * Bilirubin ≤ 2 x upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) ≤ 2.5 × ULN\n  * Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* (12) Ability to understand and the willingness to sign a written informed consent document.\n* (13) Patients with prior history of deep vein thrombosis (DVT) that has been treated or actively requiring anticoagulation are permitted to enroll.\n* (14) Due to the potential teratogenic effects, women of childbearing age must have a documented negative serum β-hCG measured within 2 weeks of starting treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician and Incyte immediately (see protocol). Additionally, both women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence).\n\nContraception should continue for 6 months after you stop taking study drug. Similarly, women must agree to not breastfeed during the entirety of the study period.\n\nExclusion Criteria:\n\n* 1\\) Diagnosis of Adult T-Cell Leukemia\u002FLymphoma (ATLL)\n* 2\\) History of autoimmune disease that requires systemic treatment.\n* 3\\) Has a diagnosis of immunodeficiency or receiving immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* 4\\) Actively chronic systemic steroids therapy (in dosing exceeding 10mg daily of prednisone or its drug equivalent).\n\n  o Patients must be off steroid therapy exceeding 10mg or greater of prednisone (or its equivalent) at the start of therapy.\n* 5\\) Patients with HL and PMBCL patients must not be eligible and agreeable to autologous stem cell transplant.\n\n  o Patients with PMBCL must not be eligible and agreeable to CAR-T.\n* 6\\) Allowed to have disease progression after or refractory to autologous bone marrow transplant.\n* 7\\) Progression after allogeneic stem cell transplantation (SCT) can be determined on a case-by-case basis after discussion with the primary investigator.\n* 8\\) History of solid organ transplant requiring active immunosuppression for which treatment with immunotherapy would be contraindicated.\n* 9\\) Active TB (Tuberculosis Bacillus) at time screening. Prior cases of adequately treated TB are permissible.\n* 10\\) Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* 11\\) Has severe hypersensitivity (≥ Grade 3) to ruxolitinib and\u002For any of its excipients.\n\nPatients with G1 and G2 hypersensitivity remain eligible.\n\n* 12\\) Inability to swallow or take medications by mouth\n* 13\\) Is pregnant or breastfeeding or expected to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* 14\\) History of concurrent and active malignancy for which he or she is currently receiving directed therapy for.\n* 15\\) History of major adverse cardiac events such as myocardial infraction or stroke within 6 months of enrollment. Cardiovascular events within 6 months such as pulmonary embolism and deep vein thrombosis is permissible if on therapeutic treatment.\n* 16\\) Subjects with active, systemic, and uncontrolled bacterial, viral, or fungal infections at the time of screening will be excluded from study participation.\n\nExceptions include:\n\nInfections that have been appropriately treated, with evidence of clinical resolution and return to baseline organ function within 14 days prior to study entry.\n\n* Localized, non-systemic infections (e.g., uncomplicated urinary tract infections or cellulitis) that are being actively managed and are not associated with systemic symptoms.\n* Please see section protocol for eligibility requirements specifically for HCV, HBV, HIV and Tuberculosis infections at time of screening.","95 Years",{"count":587,"type":21},53,[97],"The purpose of this study is to understand and determine if ruxolitinib added to pembrolizumab is safe and effective for the treatment of relapsed or refractory Hodgkin and non-Hodgkin lymphomas.",[233,591,592,593,594,128,595,596],"Hodgkin Disease Lymphoma","Non-Hodgkin Lymphoma Refractory\u002F Relapsed","Hodgkin Disease Recurrent","Gray Zone Lymphoma","Cutaneous T-Cell Lymphomas","Primary Mediastinal B Cell Lymphoma","2025-12-06",{"date":599,"type":38},"2025-12-16",{"date":601,"type":38},"2025-12-03",{"date":603,"type":21},"2029-01",{"name":605,"class":45},"Seda S. Tolu",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":629},"100548511","phase-1-linperlisib-combined-with-chidamide-in-patients-with-ptcl-100548511","NCT06421948","Linperlisib Combined With Chidamide in Patients With PTCL","PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib\u002FII Study","Inclusion Criteria:\n\n* Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study)\n* Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed\u002Frefractory PTCL). Anaplastic large cell lymphoma, NK\u002FT-cell lymphoma, and primary cutaneous T-cell lymphoma are not included.\n* ECOG PS 0-2 at protocol entry\n* Estimated life expectancy of 6 months or longer\n* Measurable disease\n* Hemoglobin ≥ 8 g\u002FdL (≥5 mmol\u002Fl); Platelets ≥ 75 x 10E9\u002FL; Absolute neutrophil count ≥ 1.0 x 10E9\u002FL; Platelets ≥ 50 x 10E9\u002FL permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serum glutamic-oxaloacetic transaminase (AST) and\u002For serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%\n* Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs; Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients previously treated with PI3K inhibitor\n* Patients previously treated with chidamide (phase Ib study is not limited by this item)\n* Suspected or documented central nervous system involvement by lymphoma\n* Patients with positive HIV and\u002For active hepatitis B and\u002For hepatitis C infection\n* Patients with active, uncontrolled infections\n* Unwillingness or inability to comply with the protocol\n* Deemed 'unfit' by the treating physician\n* Pregnant and\u002For breastfeeding women\n* Concurrent severe and\u002For uncontrolled medical disease which is not lymphoma-related\n* Patients with contraindications to chemotherapy\n* Known hypersensitivity to one or more of the study drugs","80 Years",{"count":615,"type":21},134,[24,97],"The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL).\n\nThe phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients.\n\nThe phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.",[128],"2025-12-04",{"date":621,"type":38},"2025-12-05",{"date":623,"type":38},"2024-05-25",{"date":625,"type":21},"2027-12-31",{"name":627,"class":628},"Yanyan Liu","OTHER_GOV",6,{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":22,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":652},"100521633","phase-3-to-evaluate-efficacy-of-belinostat-or-pralatrexate-in-combination-against-chop-alone-in-ptcl-100521633","NCT06072131","To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL","A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma","CRESCENDO","Inclusion Criteria:\n\n1. Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat, Pralatrexate, and CHOP. Pathology material must be available at the site for each patient before enrollment so that it can be sent to the Sponsor (or designee) for later confirmation. The following subtypes, as defined by the updated World Health Organization (WHO) classification, may be included. This information should be available for eligibility:\n\n   1. Pathology subtype:\n\n      * Peripheral T-cell lymphoma, not otherwise specified\n      * Angioimmunoblastic T-cell lymphoma\n      * Anaplastic lymphoma kinase (ALK)-negative anaplastic large-cell lymphoma (ALCL) patients are eligible only if Brentuximab Vedotin (BV) is not commercially approved for use, not available in the country or patient is contraindicated to receive BV.\n      * Follicular T-cell lymphoma\n      * Others: Extra-nodal natural killer\u002FT-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; and subcutaneous panniculitis-like T-cell lymphoma\n   2. CD30 expression and T-cell Follicular Helper (TFH) phenotype status must be available for documentation.\n2. Patient has at least 1 site of measurable disease according to Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria as assessed by the local Investigator (Appendix 3)\n3. Patient has an Eastern Cooperative Oncology Group performance (ECOG) status ≤2\n4. For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined by:\n\n   1. Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL or ≥ 1.0 × 10⁹\u002FL if evidence of bone marrow involvement\n   2. Platelet count ≥100×10⁹\u002FL or ≥ 75×10⁹\u002FL if evidence of bone marrow involvement\n   3. Total bilirubin ≤1.5 mg\u002FdL\n   4. Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) ≤ 3×upper limit of normal (ULN; AST\u002FALT ≤5×ULN if documented hepatic involvement with lymphoma)\n   5. Calculated creatinine clearance of ≥ 60 mL\u002Fmin\n5. Part 2 (Efficacy and Safety) - disease related hypoplasia, hepatological or renal dysfunction can be included if any of the treatment groups can be administered based on package insert recommendation with the following restrictions:\n\n   1. Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL or ≥ 1.0 × 10⁹\u002FL if evidence of bone marrow involvement\n   2. Platelet count ≥100×10⁹\u002FL or ≥ 75×10⁹\u002FL if evidence of bone marrow involvement\n   3. Total bilirubin ≤1.5 mg\u002FdL\n   4. Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) ≤ 3 x the upper limit of normal (ULN; AST\u002FALT ≤5×ULN if documented hepatic involvement with lymphoma)\n   5. Calculated creatinine clearance of ≥ 60 mL\u002Fmin\n6. UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal) and must be available for documentation.\n7. Patient must be willing and capable of giving written informed consent and must be able to adhere to dosing and visit schedules and meet all study requirements\n8. Patient (male or female) is at least 18 years of age at the time of informed consent\n9. Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 6 months after the last dose of study treatment.\n10. Females of childbearing potential must have a negative urine pregnancy test within 4 weeks prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.\n\nExclusion Criteria:\n\nA patient will not be eligible for inclusion if ANY of the criteria listed below apply:\n\n1. Patients with a diagnosis of:\n\n   1. Precursor T-cell lymphoma or leukemia\n   2. Adult T-cell lymphoma\u002Fleukemia\n   3. T-cell prolymphocytic leukemia\n   4. T-cell large granular lymphocytic leukemia\n   5. Primary cutaneous type ALCL\n   6. Cutaneous T-cell lymphoma (mycosis fungoides\u002FSezary syndrome)\n   7. ALCL if they can be treated with Brentuximab Vedotin (BV)\n2. Patients taking drugs which are potent UGT1A1 inhibitors must discontinue one week before randomization; drug can be resumed if the treatment doesn't include belinostat\n3. Patient with an active concurrent malignancy\u002Flife-threatening disease with the exception of non melanoma skin tumors and in situ cervical cancer if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. If there is a history of prior malignancies\u002Flife-threatening diseases, the patient must be disease free for at least 5 years\n4. Prior histone deacetylase (HDAC) inhibitor or pralatrexate therapy\n5. Any known cardiac abnormalities such as baseline prolongation of QT\u002Fcorrected QT (QTc) interval (i.e. demonstration of a QTc interval \\>450 msec); long QT syndrome; myocardial infarction within 6 months prior to starting study; history of significant cardiovascular disease; the required use of a concomitant medication that may cause Torsades de Pointes\n6. Patient with uncontrolled hypertension\n7. Patients status on the following:\n\n   1. Has a known HIV-positive diagnosis with uncontrolled and detectable viral load\n   2. Has Hepatitis B or Hepatitis C virus diagnosis with uncontrolled and detectable viral load or immunological evidence of chronic active disease\n8. Patient with central nervous system metastasis\n9. Patient with an active uncontrolled infection, underlying medical condition, laboratory abnormality, or other serious illness that would impair the ability of the patient to receive protocol treatment\n10. Patient who has used any investigational drugs, biologics, or devices within 28 days prior to study treatment or plans to use any of these during the course of the study\n11. Patient with a known history of drug or alcohol abuse\n12. Pregnant or breastfeeding women",{"count":639,"type":21},504,[125],"Part 1: This is a 5 Arm study primarily to determine the best dose out of the two dose levels of Belinostat and Pralatrexate combined with CHOP\u002FCOP in newly diagnosed PTCL patients based on Safety for part 2 study.\n\nPart 2 (Efficacy and Safety): This is a 3 Arm study. Patients with previously untreated PTCL will be randomized 1:1:1 into 1 of 3 treatment groups: 2 experimental treatment groups (Bel-CHOP or Fol-COP) or 1 active comparator treatment group (CHOP). Patients will be treated for up to 6 cycles. The primary objective is to compare the Progression Free Survival of patients with newly diagnosed PTCL treated for up to 6 cycles with Beleodaq (belinostat) in combination with CHOP (Bel-CHOP) or Folotyn (pralatrexate injection) in combination with COP (Fol-COP) to CHOP alone.",[27],"2025-10-22",{"date":645,"type":38},"2025-10-23",{"date":647,"type":38},"2023-10-04",{"date":649,"type":21},"2030-11",{"name":651,"class":113},"Acrotech Biopharma Inc.",69,{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":22,"phases":662,"briefSummary":663,"conditions":664,"keywords":665,"overallStatus":507,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":4},"100609023","phase-1-combination-therapy-with-tazemetostat-in-relapsed-and-refractory-peripheral-t-cell-lymphoma-100609023","NCT07209163","Combination Therapy With Tazemetostat in Relapsed and Refractory Peripheral T-cell Lymphoma","An Open-label, Single-arm Study Evaluating the Safety and Efficacy of Tazemetostat in Combination With Linperlisib\u002FGolidocitinib in Patients With Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n1. fully understood and voluntarily signed the ICF for this study\n2. aged ≥ 18 years;\n3. patients with R\u002FR PTCL who have received at least one prior systemic therapy.\n4. Patients must have at least one measurable lesion by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) (longest diameter of lymph node lesions \\> 1.5 cm or longest diameter of extranodal lesions \\> 1 cm); evaluable lesions: PET-CT examination showed increased local uptake in lymph nodes or extranodal sites (higher than liver) and imaging characteristics consistent with lymphoma performance\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n6. Adequate bone marrow function, renal function, liver function: ANC ≥ 1.0 × 109\u002FL, hemoglobin ≥ 8.0 g\u002FdL, platelets ≥ 75 × 109\u002FL Note: if the investigator believes that the patient 's above test values are below the lower limit of the protocol due to lymphoma invading the bone marrow, the patient can be enrolled after assessment.Creatinine clearance \\> 40 mL\u002Fmin, calculated by Cockcroft-Gault method: • serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), except for unconjugated bilirubinemia in Gilbert 's syndrome; • ALP (in the absence of bone disease), ALT, and AST ≤ 3.0 × ULN (in the presence of liver metastases, ≤ 5 × ULN); • international normalized ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n7. Current negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV), and inactive if positive:\n\n   * HBV infected patients with positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb)\\] but negative results of HBV DNA polymerase chain reaction (PCR) test can be enrolled; these patients require continuous antiviral therapy after enrollment and HBV DNA PCR test is performed every cycle;\n   * Patients with positive HCV serology but negative HCV RNA test may be enrolled;\n   * CMV IgM antibody positive,However, patients who tested negative for CMV DNA could be enrolled;\n8. female patients of childbearing potential had to agree to use a double contraception method at least 28 days before starting study drug, during treatment, and for 6 months after the last dose of study drug, and male patients with partners of childbearing potential had to also use an effective double contraception method during the study and for 3 months after the last dose of study drug, e.g., condom, sponge plug, foam, contraceptive jelly, diaphragm cap or intrauterine contraceptive device, contraceptive pills (oral or parenteral), contraceptive implant (Implanon ®), injectable intravascular injection, or other contraceptive measures.Postmenopausal women (\\> 45 years of age and amenorrheic for \\> 1 year) and surgically sterile women are exempt from this criterion.\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria must be excluded from this study:\n\n1. previously used drugs in the treatment regimen may affect the efficacy evaluation of this study (assessed by the investigator)\n2. previous bone marrow malignancies, including MDS, AML, MPN, etc.\n3. and have clinically significant abnormal test results as judged by the investigator;\n4. inability to be orally administered, previous surgical history or severe gastrointestinal diseases such as dysphagia, active gastric ulcer, etc., which the investigator believes may affect the absorption of the study drug;\n5. major surgery within 4 weeks before the first study drug administration (referring to grade 3 and 4 surgery as specified in the Measures for the Administration of Clinical Application of Medical Technology implemented on May 1, 2009);\n6. current clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any grade 3 or 4 heart disease defined by the New York Heart Association functional classification, or a history of myocardial infarction within 6 months after screening.Left ventricular ejection fraction \\\u003C 50% measured by echocardiography\n7. Venous thrombosis or pulmonary embolism within 3 months before study drug administration;\n8. History of stroke or intracranial hemorrhage within 6 months before the first study drug administration;\n9. Active infection requiring systemic treatment;\n10. History of inflammatory bowel disease (eg, Crohn 's disease or ulcerative colitis);\n11. Known hypersensitivity to study drug;\n12. Any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality of significant clinical significance that, in the judgment of the investigator, gives reason to suspect that the patient has a disease or condition that would make the use of the study drug inappropriate or would compromise the interpretation of the study results or put the patient at high risk.\n13. pregnant (positive pregnancy test) or lactating women;\n14. patients who have had previous organ transplantation;\n15. diagnosed or treated for malignancies other than PTCL, with the following exceptions: a) malignancies treated with curative therapy ≥ 3 years before randomization and without known active disease; b) adequately treated non-melanoma skin cancer or malignancies without evidence of disease",{"count":661,"type":21},48,[24,97],"In decades, the outcome of patients with peripherial T-cell lymphomas is dismal, especially in relapsed or refractory population. After failure to the frontline treatment, patients have limited treatment options and elderly population usually have no chance to undergo transplantation due to age or comorbidity, etc. EZH2 inhibitor like Tazemetostat or SHR 2554 has been demonstrated its anti-tumor activity in PTCL either alone or in combination with other targeted agents.\n\nThis study aims to explore the efficacy and safety of Tazemetostat in combination with Linperlisib\u002FGolidocitinib in Patients With Relapsed\u002FRefractory Peripheral T-cell Lymphoma in the patients with peripheral T-cell lymphoma according to next-generation sequesing results.",[27],[61,666,667,668],"Tazemetostat","Linperlisib","Golidocitinib","2025-09-30",{"date":671,"type":38},"2025-10-06",{"date":673,"type":21},"2025-10",{"date":675,"type":21},"2027-03",{"name":677,"class":45},"Ruijin Hospital",{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":683,"acronym":4,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":685,"targetDuration":4,"studyType":22,"phases":687,"briefSummary":688,"conditions":689,"keywords":697,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":712},"100380473","phase-1-phase-1-trial-of-st-001-nanofenretinide-in-relapsedrefractory-t-cell-non-hodgkin-lymphoma-100380473","NCT04234048","Phase 1 Trial of ST-001 nanoFenretinide in Relapsed\u002FRefractory T-cell Non-Hodgkin Lymphoma","A Phase 1a\u002F1b Trial in Relapsed\u002FRefractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg\u002FmL) for Intravenous Infusion","Inclusion Criteria:\n\n* All patients must have histologically or cytologically confirmed diagnosis of the following specific types of T-cell lymphomas (TCL):\n\n  1. Cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF), Sézary Syndrome (SS), or primary cutaneous CD30+ anaplastic large cell lymphoma (cALCL).\n  2. Nodal TCL: Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), or follicular T-cell lymphoma (FTCL) as defined in the 2016 revision of the WHO classification of lymphoid malignancies\\[98\\] (Appendix A).\n* For standard phase 1a and expanded cohort (1b): Patients must all have at least one measurable disease site using criteria provided in section 11.\n* Relapsed or refractory (R\u002FR) disease, after at least 1 prior treatment regimen as per disease staging (including but not limited to oral bexarotene, interferon, any oral or IV HDAC inhibitor, any topical, oral or IV chemotherapy drugs, radiotherapy, retinoids, topical steroids, systemic steroids, phototherapy, immunomodulators, Biologics and others based on PI discretion. Refer to section 2.1 of the protocol for more details).\n* Refractory disease is defined as lack of objective response (i.e., partial or complete response) to most recent therapy.\n* Relapsed disease is defined as recurrent disease after prior therapy that does not qualify as refractory disease.\n* Other systemic treatments not specified may be allowed based on PI judgement in consultation with the Sponsor.\n* For primary cutaneous lymphomas, stage IB, II, III and IV according to the TNMB system (Appendix C) are eligible. For primary nodal lymphomas, patients with stages II-IV according to the Ann Arbor staging system are eligible.\n* Minimum of 4 weeks must have elapsed since last systemic treatment or radiation therapy treatment (or 6 weeks for any nitrosourea-containing regimens), and patients must have recovered from all toxicity of last treatment. If the PI assesses that it is in the best interest of the patient to have a shorter washout period, they may submit a written request to the sponsor and can enroll the patient after written approval has been received.\n* Age ≥18 years. Both genders are included. However, women of childbearing potential must have a negative B-HCG serum pregnancy test (see Section 10 Study Calendar, Pre-Study, footnote b) and agree to use effective contraceptive methods for the duration of the study. A urine pregnancy test is required just prior to the first dosing session of every treatment cycle.\n* ECOG performance status 0-1 (Karnofsky ≥60%, see Appendix B).\n* Life expectancy greater than 6 months.\n* Patients must have normal organ and marrow function as defined below:\n* Leukocytes ≥ 3,000\u002FμL\n* Absolute neutrophil count ≥ 1,500\u002FμL\n* Platelets ≥ 100,000\u002FμL\n* Total bilirubin within normal institutional limits. Patients with total bilirubin ≤ 1.5 X upper limit of normal are eligible\n* AST (SGOT) and ALT (SGPT) within institutional upper limit of normal\n* Creatinine clearance ≥60 mL\u002Fmin\u002F1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation\n\nOr if the patient were to have bone marrow involved NHL, the hematological requirements should be as listed below:\n\n* Absolute neutrophil count ≥ 500\u002FμL\n* Platelets ≥ 50,000\u002FμL\n* Triglyceride blood level (fasting) \\\u003C300mg\u002FdL at time of enrollment (normal: \\\u003C150mg\u002FdL; borderline high = 150-199mg\u002FdL; high = 200-499mg\u002FdL; very high = 500mg\u002FdL or higher).\n* ST-001 is an experimental drug and the risks to the unborn or nursing child are unknown. Pregnant or breastfeeding women cannot take part in this study. Women of childbearing age are required to have a blood and\u002For urine pregnancy test before beginning the investigational study treatment. If you are sexually active, it is important that you not become pregnant or father a child because this medication may be harmful to your unborn child. Patients must discuss pregnancy plans with their doctor before enrolling in this study and agree that they will take the appropriate precautions not to become pregnant while enrolled in the study.\n\nIf there is any chance that patient can get pregnant, patient must either agree to not have vaginal intercourse or you must use two (2) types of birth control (hormonal, barrier method of birth control, abstinence) at the same time. These birth control methods must be used from the time of enrollment, all during investigational study treatment including during temporary breaks from therapy, and for at least 4 months after the last dose of ST-001.\n\n• Informed consent of the patient or a legal authorized representative (LAR) must be obtained prior to any study related procedures.\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Patients who are receiving any other investigational agents.\n* Patients with known or history of central nervous system (CNS) disease are excluded from this clinical trial because of their poor prognosis and because of concerns regarding toxicity attribution.\n* History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.\n* Concomitant drug administration.\n\nPatients who require concurrent treatment with drugs that are strong CYP3A inducers are excluded from the trial. Patients who have been treated previously with strong CYP3A inducers may enroll in the trial and receive their first dose of ST-001 only after four weeks have elapsed since the last dose of the CYP3A inducer. Strong inducers of human CYP3A include barbiturates, bosentan, carbamazepine, efavirenz, enzalutamide, etravirine, systemic glucocorticoids, mitotane, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, troglitazone as well as the OTC herbal product St John's Wort (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdevelopmentapprovalprocess\u002Fdevelopmentresources\u002Fdruginteractionslabeling\u002Fucm093664.htm#table2-3; http:\u002F\u002Fwww.mayomedicallaboratories.com\u002Fit-mmfiles\u002FCytochrome\\_P450\\_3A4\\_and\\_3A5\\_Known\\_Drug\\_Interaction\\_Chart.pdf; http:\u002F\u002Foncologypro.esmo.org\u002Fcontent\u002Fdownload\u002F66542\u002F1203090\u002Ffile\u002FCYP3A-inhibitors-inducers-DDI.pdf)\n\nPatients who require concurrent treatment with drugs that are strong to moderate CYP3A inhibitors are excluded from the trial, and patients who have been treated previously with strong CYP3A inhibitors may enroll in the trial and receive their first dose of ST-001 only after four weeks have elapsed since the last dose of the CYP3A inhibitor. This group of inhibitors includes certain antivirals (boceprevir, danoprevir, paritaprevir; elvitegravir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, tipranavir; ombitasvir, dasabuvir), macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin, troleandomycin) and ciprofloxacin, antifungals (e.g., clotrimazole, fluconazole, ketoconazole, itraconazole, nefazodone, posaconazole, voriconazole), aprepitant, cimetidine, cobicistat, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, idelalisib, luvoxamine, imatinib, tofisopam, suboxone and verapamil as well as dietary grapefruit juice and grapefruit (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdevelopmentapprovalprocess\u002Fdevelopmentresources\u002Fdruginteractionslabeling\u002Fucm093664.htm#table2-3; http:\u002F\u002Fwww.mayomedicallaboratories.com\u002Fit-mmfiles\u002FCytochrome\\_P450\\_3A4\\_and\\_3A5\\_Known\\_Drug\\_Interaction\\_Chart.pdf; http:\u002F\u002Foncologypro.esmo.org\u002Fcontent\u002Fdownload\u002F66542\u002F1203090\u002Ffile\u002FCYP3A-inhibitors-inducers-DDI.pdf)\n\nIf patients being treated with ST-001 require the use of drugs that are either strong inducers of CYP3A or strong to moderate inhibitors of CYP3A to treat a medical condition, all treatment with ST-001 should be discontinued immediately and no further treatment with ST-001 will be allowed.\n\nUse of acetaminophen, cephalosporins and other known hepatotoxic agents is allowed with caution and close monitoring, due to known or potential interaction with ST-001 and potential increased risk of hepatotoxicity\\[52\\]. Patients who require replacement therapy with oral steroids should be allowed to continue the treatment if treatment with stable dose has been initiated more than 2 weeks prior to beginning ST-001 infusion. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated list such as http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002F. Medical reference texts such as the Physicians' Desk Reference may also provide this information.\n\nAs part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Physician investigators should consult the websites listed above for the most current information regarding drug interactions via CYP3A isozymes.\n\nUse of vitamin A supplements is prohibited. Standard multivitamin doses are allowed.\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart classification III\u002FIV), unstable angina pectoris, cardiac arrhythmia, QTc interval \\>450 milliseconds on baseline triplicate ECG, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because ST-001is a retinoid agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ST-001, breastfeeding should be discontinued if the mother is treated with ST-001.\n* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ST-001. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Patients with any active hepatitis infections.\n* Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (eg: retinitis pigmentosa, choroidoretinitis and xerophthalmia), and glaucoma.\n* Patients who have received prior fenretinide systemic therapy\n* Patients with T-cell lymphoma types other than those specified in section 3.1.1 are not eligible even if they have cutaneous dissemination. Similarly, patients with any type of natural killer (NK)- or B-cell lymphoma are not eligible regardless of sites of involvement by disease.",{"count":686,"type":21},46,[24],"This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).",[166,690,128,691,692,693,694,695,62,696,31],"Cutaneous\u002FPeripheral T-Cell Lymphoma","Peripheral T-Cell Lymphoma, Not Classified","Primary Cutaneous T-cell Lymphoma","Cutaneous T-Cell Lymphoma, Unspecified","Cutaneous T-cell Lymphoma","Follicular T-Cell Lymphoma","Sézary's Disease",[155,698,699,700,502,701,702],"CTCL","Sézary syndrome","mycosis fungoides","AITL","cALCL","2025-09-16",{"date":705,"type":38},"2025-09-22",{"date":707,"type":38},"2023-12-18",{"date":709,"type":21},"2027-05-01",{"name":711,"class":113},"SciTech Development, Inc.",10]