[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mycosis-fungoides\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mycosis-fungoides":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,46,70,109,163,185,208,230,259,284,307,325,343,370,400,421,442,467,499,530],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":19,"type":20},21,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32],"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":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2024-01-05",{"date":41,"type":20},"2032-04-01",{"name":43,"class":44},"Mayo Clinic","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100382160","phase-2-mogamulizumab--low-dose-total-skin-electron-beam-tx-in-mycosis-fungoides--szary-syndrome-100382160","NCT04256018","Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome","A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)","Inclusion Criteria:\n\n* Stages IB-IV MF or SS\n\n  1. Stages IB-IV MF or SS\n  2. At least 1 prior standard-of-care therapy\n  3. Prior LD-TSEBT (\\> 3 months prior) and prior mogamulizumab is allowed, as long as progressive disease (PD) did not occur while on therapy, and did not discontinue due to toxicities\n  4. ≥ 18 years of age\n  5. ECOG performance status of 0 to 2\n  6. All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE, v 5.0).\n  7. MF and a known history of non-complicated staphylococcus colonization\u002Finfection is eligible provided that stable doses of prophylactic antibiotics continue.\n  8. The following minimum wash-out from previous treatments are required (prior to 1st day of treatment), if applicable.\n\n     • ≥ 2weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or other systemic anti-cancer\u002FCTCL therapies\n\n     • ≥ 2 weeks for phototherapy, local radiation therapy\n\n     • ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)\n\n     • ≥ 12 weeks for total skin electron beam therapy\n\n     • \\> 12 weeks for alemtuzumab\n\n     • Rapidly progressive malignant disease may be enrolled prior to above periods after discussion with the Protocol Director.\n  9. Adequate hematologic function\n\n     • Absolute neutrophil count (ANC) ≥ 1,000 cells\u002FμL (≥ 1,000\u002Fmm3)\n\n     • Platelets ≥ 75,000 cells\u002FμL (≥ 75,000\u002Fmm3).\n  10. Adequate hepatic function\n\n      * Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN.\n      * Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or ≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.\n  11. Adequate renal function\n\n      • Calculated creatinine clearance ≥ 30 mL\u002Fmin using the Cockcroft-Gault formula.\n  12. If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft-vs-host disease (GvHD) and receiving immunosuppressive therapy.\n  13. Women of childbearing potential (WOCBP) must have a negative pregnancy test.\n  14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.\n  15. Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.\n\n      Exclusion Criteria:\n\n  \u003C!-- -->\n\n  1. MF with limited disease (Stage IA) or central nervous system (CNS) disease\n  2. Concomitant corticosteroid use. (with the exception that topical steroid and oral prednisone are allowed at ≤ 20 mg\u002Fday, if patient has been on a stable dose for at least 2 weeks prior to 1st day of treatment)\n  3. Pregnant or breastfeeding\n  4. Active autoimmune disease or history deemed by the investigator to be clinically significant\n  5. Known human immunodeficiency virus (HIV) positivity; or active hepatitis B or C.\n  6. Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who started taking medication at least 30 days prior to the Screening Visit, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study.",{"count":54,"type":20},30,[56],"PHASE2","The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.",[59,30],"Sezary Syndrome",[61],"CTCL",{"date":36,"type":37},{"date":64,"type":37},"2020-03-30",{"date":66,"type":20},"2026-12",{"name":68,"class":44},"Stanford University",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":69},"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":79,"type":20},60,[23],"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.",[83,84,85,29,86,87,88,89,30,90],"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",[92,93,94,95,96,97,98],"CCR4","CAR T","Chemokine Receptor 4","Chimeric Antigen Receptor","Gene Therapy","Cell Therapy","Immunotherapy","2026-06-24",{"date":101,"type":37},"2026-06-25",{"date":103,"type":37},"2025-09-29",{"date":105,"type":20},"2044-06-01",{"name":107,"class":108},"National Cancer Institute (NCI)","NIH",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":116,"targetDuration":118,"studyType":119,"phases":4,"briefSummary":120,"conditions":121,"keywords":148,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100514411","a-registry-for-people-with-t-cell-lymphoma-100514411","NCT05978141","A Registry for People With T-cell Lymphoma","The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens","Inclusion Criteria:\n\n* Written informed consent\n* Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy.\n* Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines):\n\n  * T-cell prolymphocytic leukemia\n  * T-cell large granular lymphocytic leukemia\n  * Chronic lymphoproliferative disorder of NK cells\n  * Aggressive NK-cell leukemia\n  * Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood\n  * Chronic active EBV infection of T- and NK-cell type, systemic form\n  * Hydroa vacciniforme-like lymphoproliferative disorder\n  * Adult T-cell leukemia\u002Flymphoma\n  * Extranodal NK\u002FT-cell lymphoma, nasal type\n  * Enteropathy-associated T-cell lymphoma\n  * Monomorphic epitheliotropic intestinal T-cell lymphoma\n  * Intestinal T-cell lymphoma, not otherwise specified (NOS)\n  * Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract\n  * Hepatosplenic T-cell lymphoma\n  * Subcutaneous panniculitis-like T-cell lymphoma\n  * Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy)\n  * Sézary syndrome\n  * Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy)\n  * Primary cutaneous Gamma-Delta T-cell lymphoma\n  * Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma\n  * Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy)\n  * Peripheral T-cell lymphoma, not otherwise specified\n  * Angioimmunoblastic T-cell lymphoma\n  * Follicular T-cell lymphoma\n  * Nodal peripheral T-cell lymphoma with TFH phenotype\n  * Anaplastic large cell lymphoma, ALK-positive\n  * Anaplastic large cell lymphoma, ALK-negative\n  * Breast-implant associated anaplastic large cell lymphoma.\n* NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy.\n\nExclusion Criteria:\n\n* Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy.\n* Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.",{"count":117,"type":20},1000,"10 Years","OBSERVATIONAL","The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.",[122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,86,138,30,59,139,140,141,142,28,85,143,144,145,146,147],"T-cell Lymphoma","NK-Cell Lymphoma","T-cell Prolymphocytic Leukemia","T-cell Large Granular Lymphocytic Leukemia","Chronic Lymphoproliferative Disorder of NK Cells","Aggressive NK-cell Leukemia","Systemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder)","Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood","Chronic Active EBV Infection of T-and NK-Cell Type, Systemic Form","Hydroa Vacciniforme-Like Lymphoproliferative Disorder","Adult T-cell Leukemia\u002FLymphoma","Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Enteropathy-associated T-cell Lymphoma","Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma","Intestinal T-Cell Lymphoma, Not Otherwise Specified","Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","Subcutaneous Panniculitis-Like T-Cell Lymphoma","Primary Cutaneous Anaplastic Large Cell Lymphoma","Primary Cutaneous T-cell Lymphoma","Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma","Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma","Follicular T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-negative","Breast Implant-Associated Anaplastic Large Cell Lymphoma",[149,150,151,152,153],"23-190","T-cell lymphoma","Memorial Sloan Kettering Cancer Center","T-cell Lymphoma Master Repository","TCLMR","2026-05-18",{"date":156,"type":37},"2026-05-20",{"date":158,"type":37},"2023-07-27",{"date":160,"type":20},"2030-07-27",{"name":151,"class":44},26,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":69},"100503695","early-phase-1-combining-topical-imiquimod-with-local-radiotherapy-for-treatment-of-mycosis-fungoides-100503695","NCT05838599","Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides","Inclusion Criteria:\n\n* Patients must have confirmed stage IA-IIB mycosis fungoides.\n* Patients must be 18-90 years of age.\n* Patients must have failed at least one standard therapy for MF.\n* Patients must have active, but stable disease for \\>6 months.\n* Patients must have 4 or more discrete MF lesions with at least 2 of them with minimum combined surface area of \\>50cm2.\n* POCBP must have a negative pregnancy test prior to registration on study.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who are on current systemic or topical CTCL therapy, unless stable on the treatment for \\>6 months.\n* Patients who have received antibiotic therapy within 4 weeks of study enrollment.\n* Patients who are pregnant or nursing. Pregnant people are excluded from this study because IMQ is an agent with 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 gestational parent with IMQ, breastfeeding should be discontinued if the parent is treated with IMQ.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","90 Years",{"count":171,"type":20},25,[173],"EARLY_PHASE1","Mycosis fungoides (MF) is the most common subtype of cutaneous T cell lymphoma (MF) and presents as cutaneous patches, plaques, and tumors. Radiation therapy (RT) is a frequently pursued management option for CTCL, especially in patients with more advanced skin disease. Imiquimod stimulates a Th1 lymphocyte response with increased IL-2 and IFN-α, but also induces IFN-α, TNF-α, IL-1α, IL-6, and IL-8, thereby bridging both innate and adaptive immunity. Dosing of both radiotherapy (RT) and imiquimod are based on standard-of-care doses\u002Ffrequencies for CTCL. The reason imiquimod topical is given for a week before giving RT is to prime innate immune activity for when RT is delivered. It is believed that this serves as an adjuvant for the CD8+ antitumor response generated by RT. The primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.",[30],"2026-04-27",{"date":178,"type":37},"2026-05-01",{"date":180,"type":37},"2023-07-24",{"date":182,"type":20},"2027-12-01",{"name":184,"class":44},"Northwestern University",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":69},"100491548","phase-2-photopheresis-in-early-stage-mycosis-fungoides-100491548","NCT05680558","Photopheresis in Early-stage Mycosis Fungoides","THERAKOS® CELLEX Photopheresis System as an Interventional Therapy for the Treatment of Early Stage CTCL (Mycosis Fungoides), an Open-label, Single-arm, Multi-center, Phase II Study","Inclusion Criteria:\n\n1. Who are male or female, over the age of 18 and \\\u003C40 kg body weight with adequate veins to provide intravenous access.\n2. Who are willing to adhere to the protocol and sign an Informed Patient Consent Document\n3. Must not be on any other investigational device\u002Fdrug treatment.\n4. Who have the diagnosis of Mycosis Fungoides (MF) including a skin biopsy consistent with MF (atypical epidermotropic or folliculocentric T-cells) with appropriate staging as IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions.\n5. With IA stage must demonstrate a minor blood abnormality by morphology\u002Flaboratory assessment.\n6. With IIA stage - clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement.\n7. Must be willing and able to discontinue concomitant medications for MF. Subjects currently taking the following drugs must discontinue medication with the following wash out periods prior to enrollment in the trial: PUVA or UVB Therapy - 4 weeks, topical nitrogen mustard or other topical chemotherapy - 4 weeks, bexarotene capsules or other systemic biologic agent - 3 weeks washout, high dose topical steroids, topical retinoids or immunotherapy - 2 week washout with 1% topical hydrocortisone , oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency\n8. Who are refractory to at least one of the standard therapies used to treat Stage IA, IB or IIA CTCL such as oral steroids, high-dose topical steroids, topical nitrogen mustard, Bexarotene, PUVA therapy, electron beam radiation, biological response modifiers or oral methotrexate.\n9. Must be willing to abstain from therapeutic sunbathing, phototherapy, tanning beds, etc. for the duration of the study.\n\nExclusion Criteria:\n\n1. Who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB\n2. Who are unable to tolerate extracorporeal volume loss i.e., severe cardiac disease\u002Fanemia\n3. With deterioration of renal function who have a serum creatinine level greater than 3.0 mg\u002FdL.\n4. With lipemic plasma \\>500 ng\u002FdL, uncontrolled diabetes, history of liver damage (2.5 x normal alanine transaminase (ALT), aspartate aminotransferase (AST), porphyria, lupus, positive tests for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or Hepatitis B Surface Antigen, severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen, and idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen compounds, heparin, or citrate.\n5. On oral prednisone therapy or high potency topical steroids.\n6. Who are pregnant or nursing a child.",{"count":193,"type":20},74,[56],"The purpose of this study is to determine whether photopheresis therapy can be used to improve the clinical course of early stage cutaneous T-cell lymphoma (CTCL). Currently, photopheresis is performed as a palliative treatment for late stage CTCL. However, recent studies have demonstrated that patients with early stage CTCL may have markers in their blood which were previously observed primarily in late stage disease, such as clonal T cell populations. Considering these findings, the study aims to investigate whether photopheresis therapy may be used earlier in the disease course to produce a clinical response.",[197,30],"Cutaneous T Cell Lymphoma",[199],"photopheresis","2026-04-22",{"date":176,"type":37},{"date":203,"type":37},"2021-05-08",{"date":205,"type":20},"2028-07",{"name":207,"class":44},"Columbia University",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":69},"100316330","phase-2-ultra-low-dose-radiation-therapy-in-treating-patients-with-mycosis-fungoides-100316330","NCT03398161","Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides","Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides","Inclusion Criteria:\n\n* Patients with pathologically confirmed MF with cutaneous involvement.\n\n  * Patients must have clinically measurable disease of at least 1 lesion on physical (skin) exam.\n  * If a patient has a prior pathological diagnosis of MF and is clinically diagnosed with a new lesion, the new lesion is eligible for enrollment without additionally biopsy confirmation.\n* Lesions of any surface span as long as =\\\u003C 1 cm in maximal height measured from the skin surface for which local control is desired are eligible; a single patient may have multiple eligible lesions that are individually enrolled for the study.\n* All stages of disease (IA through IVB) where radiation therapy is being considered for local control are eligible. Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.\n* Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.\n* Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin \\[hCG\\]) within 2 weeks of protocol entry if the patient is unsure of their pregnancy status. Patient signature declaring that they are not pregnant on the informed consent for treatment that is used in the Department of Radiation Oncology is also an acceptable substitution for a serum pregnancy test.\n* Patients who are receiving or are planned to start topical chemotherapeutics, retinoids or imiquimod to other lesions that are not planned for enrollment are eligible; however, the lesion being considered for enrollment should not be under active therapy with these topical agents immediately prior to enrollment.\n\n  * Use of topical chemotherapeutics, retinoids or imiquimod on the lesion that is a candidate for enrollment must be halted at least 24 hours prior to enrollment in the study.\n\nExclusion Criteria:\n\n* Pregnant patients do not meet inclusion criteria for radiation therapy.\n\n  * Patients who subsequently become pregnant may continue follow up within the protocol, but a negative urine pregnancy test will need to be obtained before additional lesions may be enrolled.\n* Patients with active lupus or scleroderma\n* Lesions with a height \\> 1 cm measured from the skin surface are not eligible for this protocol.",{"count":216,"type":20},50,[56],"This phase II trial studies how well ultra low dose radiation therapy works in treating patients with mycosis fungoides. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ultra low doses of radiation may help control the disease and reduce side effects compared to treatment with higher doses.",[220,30],"Localized Skin Lesion","2026-04-10",{"date":223,"type":37},"2026-04-15",{"date":225,"type":37},"2018-01-06",{"date":227,"type":20},"2027-12-31",{"name":229,"class":44},"M.D. Anderson Cancer Center",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":243,"overallStatus":248,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":69},"100633647","phase-2-a-study-of-vg712-in-patients-with-mycosis-fungoides-100633647","NCT07529405","A Study of VG712 in Patients With Mycosis Fungoides","A Phase II Multi-center Randomized Clinical Trial to Determine the Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein (VG712) in Subjects With Mycosis Fungoides (CurbMF Trial)","CurbMF","Inclusion Criteria:\n\n1. Male and\u002For female, aged 18 years or older at the time of enrollment\n2. Stage IB-IVB histologically confirmed relapsed or refractory mycosis fungoides (MF) without Sézary syndrome, with failure of 2 or more prior systemic therapies (for progression or toxicity as assessed by the investigator). Note: Total skin electron beam therapy, narrow band UVB, and psoralen plus UV light therapy are not counted as systemic therapies\n3. ECOG performance status of 2 or less\n4. Normal lung function evaluated by pulse oximetry after 5 minutes of rest in a seated position, with oxygen saturation values between 92% and 100% without supplemental oxygen\n5. Adequate baseline organ function within 28 days before the start of study treatment, including: left ventricular ejection fraction (LVEF) of 50% or greater by MUGA scan or 2D echocardiogram without evidence of cardiac chamber hypertrophy, dilatation, or hypokinesis; no clinically significant abnormalities on a 12-lead ECG; bilirubin 1.5x ULN or less (except subjects with Gilbert's syndrome); AST and ALT each 2.5x ULN or less (or 5.0x ULN or less with known hepatic involvement by MF); calculated creatinine clearance greater than 50 mL\u002Fmin using the Cockcroft-Gault formula; serum albumin 3.2 g\u002FdL or greater (albumin infusions are not permitted to meet eligibility); platelets 75,000\u002FuL or greater, ANC 1.0x10\\^9\u002FL or greater, Hgb greater than 8 g\u002FdL (exception for subjects with low blood counts due to documented bone marrow involvement, with sponsor medical monitor approval required before enrollment)\n6. Has recovered from toxicities (except alopecia) of prior chemotherapy or radiation therapy to Grade 1 or less according to NCI-CTCAE v5.0\n7. Females and males must be willing to use an approved form of contraception while on study drug and for 3 months after the last dose of study drug\n8. Expected survival of 3 months or greater\n\nExclusion Criteria:\n\n1. Current evidence of large cell transformation (LCT) in the randomized part (subjects with clinical features suggestive of LCT must have a biopsy performed within 4 months prior to Cycle 1 Day 1 without evidence of LCT; this exclusion criterion does not apply to the lead-in dosing part)\n2. Inability to understand and give written informed consent for participation in this trial, including all evaluations and procedures specified by this protocol\n3. Allergy to diphtheria toxin, a component of A-dmDT390-bisFv(UCHT1) fusion protein\n4. Unstable or severe uncontrolled medical condition (e.g., uncontrolled diabetes, uncontrolled infections requiring systemic antibiotics, psychiatric illness\u002Fsocial situations, or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase risk to the subject)\n5. History of active malignancy within 2 years, or malignancies that may interfere with data interpretation, other than nonmelanoma skin cancer, melanoma in situ, carcinoma in situ of the uterine cervix\u002Fprostate\u002Fbladder\u002Fbreast, localized prostate cancer with PSA less than 0.1 ng\u002FmL, or thyroid cancer\n6. Clinical evidence of central nervous system MF involvement\n7. Known active, uncontrolled autoimmune disease requiring systemic corticosteroids, cytotoxic or biologic therapy. Exceptions permitted include: type I diabetes mellitus; hypothyroidism only requiring hormone replacement therapy; skin disorders such as vitiligo, psoriasis, or alopecia not requiring systemic therapy\n8. Baseline corrected QT interval greater than 470 ms; baseline QT interval corrected with Fridericia's method (QTcF) greater than 470 ms (average of triplicate ECG)\n9. Poorly controlled hypertension defined as systolic BP greater than 160 mmHg or diastolic BP greater than 90 mmHg on 2 consecutive measurements separated by 1 week despite 2 antihypertensive medications. Subjects receiving a beta blocker for hypertension must be converted to another antihypertensive drug class (angiotensin inhibitors, angiotensin receptor blockers, or calcium channel blockers are all acceptable) at least 2 weeks before receiving study drug\n10. History of or currently active cardiovascular disease within 12 months before the first dose of study drug, including: myocardial infarction or coronary artery bypass grafting, cardiomyopathy, unstable angina pectoris, clinically significant cardiac arrhythmia, congestive heart failure (NYHA Class III or IV), or cerebrovascular accident. Atrial fibrillation is allowed if rate is controlled (resting heart rate less than 90 bpm and less than 180 bpm during exercise)\n11. Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the investigator would put the subject at significant risk for pulmonary complications during the study\n12. Pregnant or nursing women\n13. Known active or prior infection with HIV, or active infection with HBV or HCV. However, the following subjects may be included: HIV subjects must have been on established anti-retroviral therapy for at least 4 weeks, have an HIV viral load less than 400 copies\u002FmL, CD4+ T-cell counts of 350 cells\u002FuL or greater, and no AIDS-defining opportunistic infections within the past 12 months; HBV subjects with prior HBV infection (surface antigen or core antibody positive) receiving suppressive antiviral therapy with an undetectable hepatitis B viral load may be included and suppressive antiviral therapy must be continued throughout treatment and for 12 months after completion; HCV subjects with a history of HCV infection who have completed curative antiviral treatment and have HCV viral load below the limit of quantification may be included\n14. History of cirrhosis of the liver based on the Child-Pugh score of Class B or C\n\n14\\. Any therapy directed against the subject's underlying cancer or any investigational medications within 4 weeks of enrollment (skin-directed treatments, including topicals and radiation, are allowed within 2 weeks of enrollment) 16. Prior treatment with alemtuzumab (Campath) or similar agents or procedures that depress blood T-cell counts if current CD4+ T-cell counts are less than 200\u002FuL 17. Severe allergic reactions to monoclonal antibodies or therapeutic proteins 18. Use of corticosteroids within 14 days before the first dose of study drug, except as indicated for medical conditions other than MF such as intraarticular corticosteroid injections, intraocular corticosteroid drops, inhaled or nasal corticosteroids, and replacement doses of systemic corticosteroids. Note: subjects on a stable, low dose of a systemic corticosteroid (20 mg prednisone equivalent or less) and\u002For medium or low potency topical corticosteroids to control MF for at least 4 weeks prior to Cycle 1 Day 1 are allowed and may continue, although the investigator should attempt to taper to the lowest dosage tolerable 19. Receipt of any live vaccine (e.g., varicella, pneumococcus) within 30 days of the first dose of study drug 20. Prior treatment with mogamulizumab 21. Pregnant, breastfeeding, or planning to become pregnant during study treatment or within 3 months after the last dose of study drug 22. Planning to donate or bank eggs (ova, oocytes) during study treatment and for 90 days after the last dose of study drug",{"count":239,"type":20},386,[56],"VG712 (A-dmDT390-bisFv(UCHT1) fusion protein) is a recombinant anti-CD3 immunotoxin that selectively depletes CD3-positive T cells through irreversible inhibition of protein synthesis. This Phase II study (CurbMF-001) evaluates the safety and efficacy of VG712 compared with mogamulizumab in subjects with relapsed or refractory mycosis fungoides (MF) who have failed 2 or more prior systemic therapies. The study has two parts: a lead-in dosing part (BOIN design, up to 24 subjects) to determine RP2D, followed by a randomized part (approximately 322 subjects, 1:1 VG712 vs. mogamulizumab). Sponsor: Virogen Biotechnology Inc.",[30],[30,61,244,245,246,247],"Immune Reset","VG712","Immune Reconstitution","A-dmDT390-bisFv(UCHTI)","NOT_YET_RECRUITING","2026-04-07",{"date":251,"type":37},"2026-04-14",{"date":253,"type":20},"2026-07-30",{"date":255,"type":20},"2032-12-30",{"name":257,"class":258},"Virogen Biotechnology Inc.","INDUSTRY",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},"100330869","phase-2-dosing-of-brentuximab-vedotin-for-mycosis-fungoides-sezary-syndrome-patients-100330869","NCT03587844","Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients","Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis","Inclusion Criteria:\n\nMycosis fungoides (MF) and Sezary Syndrome (SS)\n\n1. Pathologically confirmed mycosis fungoides\u002Fsezary syndrome at the enrolling institution, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher\n\n   ° CD30 negative mycosis fungoides patients are eligible.\n2. Age ≥ 18 years\n3. ECOG Performance Score ≤ 2\n4. For Cohort 1, patients who have not received brentuximab vedotin are eligible.\n5. For Cohort 2, patients who have previously had brentuximab vedotin for MF\u002FSS are eligible. Patients previously treated on Cohort 1 who were discontinued due to toxicity are not eligible for Cohort 2.\n6. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.\n\n   ° See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant and maintenance therapy for prior malignancy.\n7. Topical or systemic steroids (equivalent to ≤ 10 mg\u002Fday of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and\u002For unnecessary suffering, after discussion with PI.\n8. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \\>200 within 7 days prior to C1D1.\n9. Females of childbearing potential must be on acceptable form of birth control per instutional standard.\n\nLymphomatoid papulosis (LyP)\n\n1. Pathologically confirmed lymphomatoid papulosis at the enrolling institution\n2. Requiring systemic treatment per investigator's discretion\n3. Age ≥ 18 years\n4. ECOG Performance Score ≤ 2\n5. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.\n6. Topical or systemic steroids (equivalent to ≤ 10 mg\u002Fday of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and\u002For unnecessary suffering.\n7. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \\>200 within 7 days prior to C1D1.\n8. Females of childbearing potential must be on acceptable form of birth control per institutional standard\n\nExclusion Criteria:\n\n1. Concurrent use of other systemic anti-cancer agents or treatments for mycosis fungoides\u002Fsezary syndrome, or lymphomatoid papulosis.\n2. Grade 2 or greater neuropathy\n3. Severe renal impairment (CrCL \\\u003C30 mL\u002Fmin)\n4. Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C)\n\n   ° See Appendix E for Child Pugh Classification chart\n5. Women of reproductive potential† must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with treating provider.\n6. Previous use of brentuximab vedotin (for Cohort 1 ONLY)\n7. Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma).\n\n   * Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.\n   * Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK Principal Investigator.\n8. For Cohort 2, patients who previously progressed on the standard 1.8mg\u002Fkg dose and schedule of brentuximab vedotin are ineligible.\n\n   * A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).",{"count":267,"type":20},58,[56],"The purpose of this study is to test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.",[30,271,59],"Lymphomatoid Papulosis",[273,274],"Brentuximab Vedotin","18-147","2026-04-02",{"date":277,"type":37},"2026-04-03",{"date":279,"type":37},"2018-07-03",{"date":281,"type":20},"2027-07",{"name":151,"class":44},8,{"id":285,"slug":4,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100552235","NCT06470451","Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL","A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)","FLASH2","Inclusion Criteria:\n\n* Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.\n* Patients with a minimum of three (3) evaluable, discrete lesions.\n* Patients willing to follow the clinical protocol and voluntarily give their written informed consent.\n* Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.\n\nExclusion Criteria:\n\n* History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling.\n* History of allergy or hypersensitivity to any of the components of HyBryte.\n* A Screening ECG with a QT interval \\>470 ms (corrected for heart rate using the Fridericia's formula).\n* All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.\n* Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.\n* Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment.\n* Patients who have received electron beam irradiation within 3 months of enrollment.\n* Patients with a history of significant systemic immunosuppression.\n* Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.\n* Patients whose condition is spontaneously improving.\n* Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).\n* Patients with extensive skin disease (\\>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.\n* Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.\n* Prior participation in the current study.",{"count":292,"type":20},80,[294],"PHASE3","To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch\u002Fplaque phase cutaneous T-cell lymphoma (mycosis fungoides).",[297,61,30,197],"CTCL\u002F Mycosis Fungoides","2026-03-30",{"date":277,"type":37},{"date":301,"type":37},"2025-01-07",{"date":303,"type":20},"2026-10",{"name":305,"class":258},"Soligenix",17,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":69},"100532054","long-term-outcomes-associated-with-juvenile-onset-mycosis-fungoides-and-lymphomatoid-papulosis-100532054","NCT06207812","Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis","Inclusion Criteria:\n\n-To be eligible, participants had to be diagnosed with jMF or lyp before age 20. In the case of participants below the age of 18, parents and not the children will be contacted for participation (children are exempt from participation as their parents may answer our study questions).\n\nExclusion Criteria:\n\n-Participants older than 20 years of age at diagnosis",{"count":314,"type":20},100,"To follow up with all our participants with juvenile-onset mycosis fungoides, check on their status, and ask them or their parents about long term outcomes associated with their condition.",[271,30],"2026-01-23",{"date":319,"type":37},"2026-01-26",{"date":321,"type":37},"2024-01-19",{"date":323,"type":20},"2028-01-12",{"name":229,"class":44},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":69},"100466750","phase-2-effectiveness-of-concurrent-ultra-low-dose-total-skin-electron-beam-therapy-and-brentuximab-vedotin-given-quarterly-over-12-months-for-patients-with-mycosis-fungoides-100466750","NCT05357794","Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides","Inclusion Criteria:\n\n1. Biopsy-confirmed mycosis fungoides in stage I-IV (APPENDICES 3 AND 4); the presence of Sezary cells in the blood is acceptable at original diagnosis or at enrollment into the protocol, as long as the patient has current mycosis fungoides in the skin and the sesary cells in peripheral blood are \\\u003C 1000 cells\u002F microlitre at the time of enrollment.\n2. Participants with relapsed\u002F refractory mycosis fungoides expressing at least 1% CD30 are eligible.\n3. Previous systemic anticancer therapy must have been discontinued at least 1 week before treatment\n4. In the case of myelosuppressive chemotherapy treatment may start once counts have recovered including absolute WBC\\> 1000, platelets\\> 50K.\n5. Topical or systemic steroids (equivalent to 10 mg\u002Fday of prednisone) may be considered if the dose of such steroids has been constant and their discontinuation may lead to rebound flare in disease, adrenal insufficiency, and\u002For unnecessary suffering, after discussion with the Principal Investigator.\n6. 18 years of age or older\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 3 (APPENDIX 5)\n8. No required wash-out period for prior therapies\n9. HIV+ participants must be on stable antiretroviral treatment for 12 weeks before the first day of cycle 1 (C1D1), with CD4 count \\>200 within the 7 days before C1D1.\n10. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Concurrent use of other systemic anticancer agents or treatments (including steroids unless adrenal insufficiency has been diagnosed) for mycosis fungoides or Sezary syndrome\n2. Grade 2 or greater neuropathy\n3. Severe renal impairment (creatinine clearance \\[CrCL\\] \\\u003C30 mL\u002Fmin)\n4. Moderate or severe hepatic impairment (Child-Pugh B or C; see APPENDIX 6 for ChildPugh classification chart)\n5. Women of reproductive potential must have a negative serum ß human chorionic gonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with the treating provider. And agree to use adequate birth control measures (oral, implanted, or barrier methods) while on study Female participants of childbearing potential who are not abstinent and intend to be sexually active with a non sterilized male partner must use at least 1 highly effective method of contraception (Failure rate of \\\u003C1% per year when used consistently and correctly) throughout the total duration of the drug treatment and the drug washout period as determined by your physician. Non-sterilized male partners of a female participants of childbearing potential must use male condom plus spermicide throughout this period. Cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Female participants should also refrain from breastfeeding throughout this period. Highly effective contraceptive methods:\n\n   * Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation\n\n     * oral\n     * intravaginal\n     * transdermal\n   * Progestogen-only hormonal contraception associated with inhibition of ovulation\n\n     * oral\n     * injectable\n   * Implantable progestogen-only hormonal contraception associated with inhibition of ovulation b\n   * Intrauterine device (IUD)c\n   * Intrauterine hormone-releasing system (IUS)c\n   * Bilateral tubal occlusion\n   * Surgical Sterilization\n6. Receipt of systemic therapy for another primary malignancy (other than T-cell lymphoma). Participants with more than one type of lymphoma may be enrolled after discussion with the Principal Investigator\n7. Underlying medical conditions including unstable cardiac disease, or other serious illness that would impair the ability of participants to undergo treatment\n8. Any other medical history, including laboratory results, deemed by the Principal Investigator to be likely to interfere with participants participation in the study\n9. Use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, should be avoided given the potential effect on exposure to monomethyl auristatin E.",{"count":54,"type":20},[56],"To learn if a form of radiation therapy (called ultra-low-dose - total skin electron beam therapy \\[ULD-TSEBT\\]) in combination with brentuximab vedotin can help to control mycosis fungoides",[30],"2026-01-09",{"date":337,"type":37},"2026-01-12",{"date":339,"type":37},"2022-10-13",{"date":341,"type":20},"2027-01-30",{"name":229,"class":44},{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":352,"conditions":353,"keywords":357,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":69},"100071017","blood-urine-and-tissue-collection-for-cutaneous-lymphoma-eczema-and-atopic-dermatitis-research-100071017","NCT00177268","Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research","Peripheral Blood, Urine and Skin Sample Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research","Inclusion Criteria:\n\n* 18 or older\n* able and willing to provide informed consent\n* diagnosed with CTCL\n* diagnosed with either atopic dermatitis or eczema\n\nExclusion Criteria:\n\n* Lack of CTCL, atopic dermatitis, or eczema diagnosis in medical record",{"count":351,"type":20},200,"This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.",[354,59,30,355,356],"Cutaneous T-cell Lymphoma","Eczema","Atopic Dermatitis",[354,59,30,358,359,360],"Blood\u002Ftissue banking","eczema","atopic dermatitis","2025-12-23",{"date":363,"type":37},"2025-12-30",{"date":365,"type":37},"2004-10",{"date":367,"type":20},"2032-01",{"name":369,"class":44},"University of Pittsburgh",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":21,"phases":379,"briefSummary":380,"conditions":381,"keywords":388,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":45},"100571162","phase-2-jak1-inhibitor-golidocitnib-for-the-treatment-of-relapsedrefractory-indolent-tnk-cell-lymphomas-100571162","NCT06716658","JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed\u002FRefractory Indolent T\u002FNK-cell Lymphomas","Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed\u002FRefractory Indolent T\u002FNK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years, with no restrictions on gender;\n2. Histologically confirmed relapsed\u002Frefractory (R\u002FR) indolent T\u002FNK-cell; lymphoma that has failed at least one systemic therapy or is intolerant to such treatment and\u002For currently has no effective standard treatment options;\n3. The patient meets the criteria for appropriate therapeutic indications;\n4. ECOG performance status of 0-2;\n5. Adequate organ function, defined as: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN)\u002FUrea and creatinine (Cr) ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF): \\\u003C 450 ms for males, \\\u003C 470 ms for females;\n6. An expected survival time of at least 3 months;\n7. Male and female subjects of childbearing potential must agree to use effective contraception throughout the study period and for 6 months after the last dose of the investigational drug;\n8. A washout period of ≥ 4 weeks since receiving any prior antitumor therapies (including radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy) before participating in this study;\n9. The subject has not participated in any other clinical trial within 1 month prior to enrollment;\n10. The subject agrees to and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects who have previously used any JAK inhibitors;\n2. Subjects with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and\u002For absorption of the study drug;\n3. Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);\n4. Subjects with HBV or HCV infections, defined as HBsAg and\u002For HBcAb positivity and HBV DNA copy number ≥ the upper limit of normal (ULN), or acute or chronic active hepatitis C (HCV antibody-positive);\n5. Subjects with a history of immunodeficiency, including those who are HIV-positive, or those with other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation;\n6. Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;\n7. Subjects with severe or uncontrolled cardiovascular diseases;\n8. Subjects with severe concomitant diseases that pose a significant risk to patient safety or, in the investigator's judgment, may interfere with the completion of the study (e.g., uncontrolled hypertension, diabetes, or thyroid disorders);\n9. Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;\n10. Subjects with a history of other malignancies diagnosed or treated within the past 5 years;\n11. Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.",{"count":378,"type":20},48,[56],"Indolent T\u002FNK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T\u002FNK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T\u002FNK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed\u002Frefractory indolent T\u002FNK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.",[382,383,384,197,385,386,387,137,142,30],"Lymphoma, T-Cell","NK-LGL Leukemia","T-LGL Leukemia","Cutaneous T Cell Lymphoma (CTCL)","Large Granular Lymphocyte Leukemia","Large Granular Lymphocytic Leukemia",[389,390],"Indolent T\u002FNK-cell lymphomas","JAK1 inhibitor","2025-11-14",{"date":393,"type":37},"2025-11-18",{"date":395,"type":37},"2024-12-25",{"date":397,"type":20},"2028-11-15",{"name":399,"class":44},"Institute of Hematology & Blood Diseases Hospital, China",{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":420},"100274133","id-of-prognostic-factors-in-mycosis-fungoidessezary-syndrome-100274133","NCT02848274","ID Of Prognostic Factors In Mycosis Fungoides\u002FSezary Syndrome","Prospective Multicenter International Observational Study for Determination of a Cutaneous Lymphoma International Prognostic Index Model and Impact of Major Therapies in Patients With Advanced Mycosis Fungoides and Sézary Syndrome","Inclusion Criteria\n\n* Diagnosis of advanced stage MF or SS (Stages IIB - IVB) within 6 months of presentation to the participating center\n* Patients that are expected to have care administered at the participating center or jointly with referring physician(s) where follow-up data would be available\n\nExclusion Criteria\n\n* Patients diagnosed with early stage MF\u002FSS (Stages IA-IIA) before progressing to advanced stage\n* Patients diagnosed with advanced MF\u002FSS more than 6 months prior to initial presentation to the participating center\n* Exclude one-time consultation type of new patients.",{"count":408,"type":20},2000,"The purpose of the study is to develop a prognostic index model for the rare disease of mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical data at various institutions. The investigators hope this will enable the identification of low- and high-risk groups for survival in order to improve patient care and outcome.",[30,411],"Non-Hodgkin's Lymphoma","2025-10-20",{"date":414,"type":37},"2025-10-22",{"date":416,"type":37},"2016-10",{"date":418,"type":20},"2027-03",{"name":68,"class":44},13,{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":21,"phases":429,"briefSummary":430,"conditions":431,"keywords":432,"overallStatus":248,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":4},"100609384","early-phase-1-a-phase-1-multicenter-open-label-prospective-first-in-human-dose-escalation-clinical-trial-of-domain-therapeutics-anti-ccr8-monoclonal-antibody-dt-7012-in-patients-with-relapsed-or-refractory-cutaneous-t-cell-lymphomas-ctcl-100609384","NCT07213882","A Phase 1, Multicenter, Open-label, Prospective, First-in-human Dose-escalation Clinical Trial of Domain Therapeutics' Anti-CCR8 Monoclonal Antibody (DT-7012) in Patients With Relapsed or Refractory Cutaneous T-cell Lymphomas (CTCL)","CITY","Inclusion Criteria:\n\n1. Adult Patients (≥18 years) with no upper age limit\n2. Confirmed diagnosis of mycosis fungoides or Sezary syndrome\n3. Stage IB to IVB in the ISCL \u002F EORTC classification\n4. Relapsed or refractory (no response) after at least two systemic treatments\n5. ECOG performance status 0-1\n6. Adequate liver function:\n\n   * Total bilirubin ≤ 1.5 xULN, or Direct bilirubin ≤ 1.5xULN if total bilirubin is \\>1.5xULN, or total bilirubin \\>1.5 xULN if elevated total bilirubin is attributed to Gilbert's syndrome or to histologically-proven liver involvement by CTCL\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2,5 x ULN, unless elevated to up to 5 x ULN due to CTCL\n7. Adequate hematological function:\n\n   * Absolute neutrophil count of ≥ 1.5 G\u002FL without G-CSF support for at least 7 days\n   * Platelet count of ≥ 75 G\u002FL without platelet transfusion within 7 days\n   * Hemoglobin ≥ 9 g\u002FdL without RBC transfusion within 7 days\n8. Adequate renal function: creatinine clearance calculated by Cockcroft \\& Gault formula of ≥ 50 mL\u002Fmin\n9. HBV: negative blood HBs Ag or blood HBV DNA. Vaccinated patients may be included. Patients with HBc antibody may be included if HBV DNA is negative\n10. HCV: negative HCV serology, or negative HCV RNA if HCV serology is positive\n11. HIV: negative HIV serology\n12. Negative serum or urinary pregnancy test within 7 days or at baseline prior to study treatment in women of childbearing potential\n13. Patients must agree to use a highly effective contraceptive method from inclusion until:\n\n    * If the patient is a male: at least 6 months after the last dose of DT-7012. Men must refrain from donating sperm during this same period\n    * If patient is a female of childbearing potential: at least 6 months after the last dose of DT-7012\n14. Patients must have the following minimum wash-out from previous treatments:\n\n    * 12 weeks for total skin electron beam irradiation,\n    * 4 weeks for monoclonal antibodies\n    * 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-neoplastic investigational agents\n    * 3 weeks for systemic retinoids, interferons, vorinostat, romidepsin, fusion proteins\n    * 3 weeks for phototherapy\n    * 2 weeks for topical therapy (including steroids, retinoids, nitrogen mustard or imiquimod). Topical steroids and oral steroids (10 mg prednisone equivalent\u002Fday maximum) are allowed, if the patient has been on a stable dose with stable symptoms for at least 4 weeks prior to study entry.\n15. Patient covered by any social security system (registered or being a beneficiary of such a scheme) for French participants only\n16. Signed informed consent\n\nExclusion Criteria:\n\n1. Known central nervous system involvement by CTCL\n2. Participation in any study of a health product within 30 days prior to study entry\n3. Patients with a history of other malignancies during the past three years (except for: non-melanoma skin cancer, lymphomatoid papulosis, curatively treated localized prostate cancer, curatively treated localized breast cancer, resected thyroid cancer, biopsy proven cervical intraepithelial neoplasia or cervical carcinoma in situ, which are not considered exclusion criteria).\n4. Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), or angina, myocardial infarction, cerebrovascular accident, transient ischemic attack within 6 months prior to study entry\n5. Any severe acute or chronic medical or psychiatric condition\n6. Patients with immunodeficiency\n7. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 1 week prior to first study drug dose\n8. Chronic use of systemic corticosteroids of prednisone or equivalent \\>10 mg prednisone equivalent\u002Fday for a chronic condition (washout of 8 days from start of treatment is accepted)\n9. Other immunosuppressive therapies are also excluded, (washout of 7 days from start of treatment is accepted)\n10. Autologous Hematopoietic Stem Cell Transplantation (HSCT) within 100 days prior to DT-7012 infusion\n11. Prior allogeneic HSCT\n12. Prior solid organ transplantation\n13. Patient with history of confirmed progressive multifocal leukoencephalopathy\n14. Known or suspected allergies, hypersensitivity, or intolerance to DT-7012 or its excipients\n15. Pregnant or breast-feeding woman, or desire (for both man and woman participant) to conceive a child within 6 months after end of treatment\n16. Patient under guardianship or curatorship and protected adults or unable to consent\n17. Coagulation disorder contra indicating intravenous infusion\n18. History of anaphylactic reaction following vaccination or immunotherapy\n19. History or current immune pneumonitis or interstitial lung disease",{"count":54,"type":20},[173],"Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of lymphomas characterized by a primary involvement of the skin. Among them, mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes. SS is defined as erythroderma (erythema of the entire skin surface), and circulating tumor blood cells. The circulating tumor T cells express CD4 and may lose expression of CD7 and CD26, while exhibiting in most cases aberrant expression of CD158k (KIR3DL2), which is a surface marker of Sézary cells. CCR8 is a surface marker of tumor-infiltrating regulatory T cells. It has recently be observed that CCR8 was expressed by tumor cells in CTCL and other peripheral T-cell lymphomas. CCR8 is expressed by skin resident-memory T cells which are believed to be the tumor cell-of-origin in mycosis fungoides. Domain Therapeutics (DT) showed the in vitro efficacy of their proprietary anti-CCR8 mAb DT7012 in the depletion of CTCL cells. Therapeutic depletion of CCR8-expressing cells by DT-7012 could eliminate tumor cells and activate the anti-tumor immunity in CTCL. We hypothesize that treatment with DT-7012 is effective in the treatment of relapsed or refractory (R\u002FR) CTCL as advanced MF and SS.",[385,30,59],[197,30,59],"2025-10-02",{"date":435,"type":37},"2025-10-09",{"date":437,"type":20},"2026-01-01",{"date":439,"type":20},"2028-08-01",{"name":441,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":16,"minAge":448,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":451,"conditions":452,"keywords":453,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":466},"100603134","assessment-of-safety-and-efficacy-of-poteligeo-inj-20-mg-mogamulizumab-through-use-result-surveillance-100603134","NCT07132567","Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance","Inclusion Criteria:\n\n1. Adults 19 years of age or older\n2. Individuals who are confirmed to have received administration of the study drug for the purpose of \"the treatment for adult patients with fungoidal granuloma or Sezary syndrome who have received one or more systemic therapies,\" or who are considered to require administration of the study drug in the investigator's opinion\n3. Individuals who (or whose legally acceptable representatives) signed the Consent to Use of Personal Information of their own free will for participation in this use-result surveillance\n\nExclusion Criteria\n\n1. Patients with hypersensitivity to any ingredients of this drug\n2. Patients who intend to use this drug for non-approved indications\n3. Patients who participated in a pre-market clinical trial of the study drug and received administration of the study drug","19 Years",{"count":450,"type":20},15,"The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.",[30,59],[454,455,456],"Poteligeo","mycosis fungoides","Sezary syndrome","2025-09-19",{"date":459,"type":37},"2025-09-22",{"date":461,"type":37},"2025-05-02",{"date":463,"type":20},"2028-11",{"name":465,"class":258},"Kyowa Kirin Co., Ltd.",6,{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":21,"phases":476,"briefSummary":477,"conditions":478,"keywords":484,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":498},"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":475,"type":20},46,[23],"This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).",[122,479,480,481,140,482,354,143,85,483,30],"Cutaneous\u002FPeripheral T-Cell Lymphoma","Peripheral T-cell Lymphoma","Peripheral T-Cell Lymphoma, Not Classified","Cutaneous T-Cell Lymphoma, Unspecified","Sézary's Disease",[485,61,486,455,487,488,489],"Lymphoma","Sézary syndrome","PTCL","AITL","cALCL","2025-09-16",{"date":459,"type":37},{"date":493,"type":37},"2023-12-18",{"date":495,"type":20},"2027-05-01",{"name":497,"class":258},"SciTech Development, Inc.",10,{"id":500,"slug":501,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":506,"sex":16,"minAge":17,"maxAge":507,"enrollmentInfo":508,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":69},"100431902","predictive-and-prognostic-biomarkers-in-patients-with-mycosis-fungoides-and-szary-syndrome-100431902","NCT04904146","Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.","BIO-MUSE","Inclusion Criteria:\n\n* Age 18-100 years\n* Histologically confirmed (according to the World Health Organization (WHO)\u002FEORTC classification) MF\u002FSS stages I-IV\n* WHO performance status 0 -3\n* Absence of psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study.\n* Written informed consent according to International Conference on Harmonization (ICH)\u002F(Good Clinical Practice (GCP), and Swedish regulations\n* No minimum or maximum required routine laboratory data\n\nExclusion Criteria:\n\nNot applicable. No exclusion criteria are specified.",true,"100 Years",{"count":509,"type":20},120,"A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.",[30,59],[513,514,456,515,516,517,518,519,520],"Skin lymphoma","Mycosis fungoides","Translational research","Biomarkers","Treatment prediction","Lymphoma microenvironment","Skin neoplasms","Treatment","2025-03-05",{"date":523,"type":37},"2025-03-10",{"date":525,"type":37},"2021-04-02",{"date":527,"type":20},"2027-04",{"name":529,"class":44},"Lund University Hospital",{"id":531,"slug":532,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":21,"phases":540,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":248,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":4},"100455081","phase-3-total-skin-electron-beam-therapy-low-dose-for-tumor-clone-eradication-in-early-stage-mycosis-fungoides-100455081","NCT05205902","TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides","TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides: a Prospective Randomized Controlled Study","TOTEM-01","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histopathologically confirmed diagnosis of International Society for Cutaneous Lymphomas (ISCL) \u002F European Organisation for Research and Treatment of Cancer (EORTC) mycosis fungoides stage IB or IIA\n\nExclusion Criteria:\n\n* Poor performance status: WHO performance status score \\> 2\n* Physically unable to maintain the posture\n* Patient with no health coverage\n* Patient under guardianship or curatorship\n* Previous history of dose-limiting radiation therapy in the field\n* Previous history of dose-limiting phototherapy\n* Previous history of melanoma, skin squamous cell carcinoma or basal cell carcinoma or other absolute contraindication to phototherapy (including a history of lupus, xeroderma pigmentosum, or porphyria)\n* Pregnant or breastfeeding woman\n* Contraindication to methoxsalen (severe liver, renal or heart failure)",{"count":539,"type":20},78,[294],"Primary cutaneous T-cell lymphomas are a group of peripheral T-cell lymphomas that primarily involve the skin. Mycosis fungoides (MF) is the most frequent subtype. Most patients with early-stage MF (i.e., patches and plaques of the skin without extracutaneous involvement) have a good prognosis but a subset of patients progress to incurable advanced-stage disease with an overall survival (OS) less than 5 years and an impaired quality of life.\n\nWe have recently identified the tumor clone frequency in lesional skin (measured by high-throughput sequencing of the TCRB locus) as the most important prognostic factor of progression-free survival (PFS) and OS in a retrospective analysis on 210 patients with early-stage MF (p\\\u003C0.001).\n\nPhototherapy is a standard therapeutic option in early-stage MF but fails to eradicate the tumor clone from the skin.\n\nLow-dose total-skin electron-beam therapy (LDTSEBT, 12 Gy over a 3-week period) has been shown to be safe and highly effective in MF with an 88% overall response rate and a better safety profile compared to standard-dose total-skin electron-beam therapy, in a pooled analysis from 3 phase II trials on 33 patients and a retrospective analysis of 12 patients treated with LDTSEBT.\n\nWe hypothesize that the use of LDTSEBT is associated with a significantly higher 1-year PFS compared to conventional treatment with phototherapy. Our secondary hypotheses are that LDTSEBT is associated with a higher tumor T-cell clone eradication compared to phototherapy, and improves OS and quality of life in patients with skin-limited MF.\n\nThe main objective of this study is therefore to prospectively determine if LDTSEBT is associated with a higher 1-year progression-free survival in patients with early-stage mycosis fungoides, compared to conventional treatment with phototherapy.\n\nThe primary endpoint is PFS at 12 months after study inclusion.",[30,197],"2022-01-24",{"date":545,"type":37},"2022-01-25",{"date":547,"type":20},"2022-02",{"date":549,"type":20},"2031-02",{"name":441,"class":44}]