[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-t-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-t-cell-lymphoma":326},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,39,72,113,140,162,183,202,224,257,268,289,315,341,368,397,429,464,486,510,536,557,577,599,621],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100054066","phase-2-a-phase-2-trial-to-assess-safety-and-efficacy-of-tofacitinib-2-cream-in-the-treatment-of-cutaneous-t-cell-lymphoma-ctcl-stages-ia-ib-and-iia-100054066",false,"NCT06698822","A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA","Inclusion Criteria:\n\n* Age ≥18 years at screening visit. Because limited dosing and adverse event data are currently available on the use of tofacitinib in participants \\\u003C18 years of age, children are excluded from this study.\n\n  * Have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL) stage IA, IB, or IIA including documentation of a skin biopsy with histological findings consistent with CTCL.\n  * For stage IIA, only participants with a classification of N0 (no clinically abnormal peripheral lymph nodes) or N1 (clinically abnormal lymph node(s) histopathology Dutch grade 1 or NCI LN0-2) can be enrolled.\n  * Participants must be B0 (absence of significant blood involvement: .5% of peripheral blood lymphocytes of \\\u003C250\u002FmcL are atypical.\n  * Have at least 2 distinct lesions that have either failed or recurred despite treatment with 1 previous standard therapy.\n  * ECOG performance status ≤ 2 (Karnofsky .60%)\n  * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n  * The effects of tofacitinib on the developing human fetus are unknown. Available data with tofacitinib in its oral formulation in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Therefore, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n    1. Postmenopausal (no menses in greater than or equal to 12 consecutive months)\n    2. History of hysterectomy or bilateral salpingo-oophorectomy\n    3. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)\n    4. History of bilateral tubal ligation or another surgical sterilization procedure\n  * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of tofacitinib administration.\n\n    * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tofacitinib\n\n  * Skin infection and\u002For skin ulceration at screening and baseline visit\n  * Any subject with a diagnosis of active malignancy or a cancer requiring treatment of expected to require treatment during the course of the trial (not including basal cell carcinoma, squamous cell carcinoma of the skin, malignant melanoma in situ, or cervical carcinoma in situ)\n  * Any uncontrolled or serious underlying disease or medical or surgical condition that may interfere with interpretation of the trial results and\u002For place the subject at significant risk according to investigator discretion including but not limited to severe cardiac, psychiatric, hematologic, and thyroid conditions\n  * History of Stage IIB or greater CTCL, or stage IIA CTCL with history of stage N2 (Dutch Grade 2 or NCI LN3 or greater), or with \\>5% circulating Sezary cells\n  * History of aggressive CD8+ CTCL disease\n  * Having received one of the following treatments within the specified timeframes (calculated from baseline visit):\n\n    * In the past 12 weeks: Total Skin Electron Beam Therapy (TSEBT)\n    * In the past 8 weeks: topical imiquimod\n    * In the past 4 weeks: topical corticosteroids, topical chemotherapy, topical retinoids, local radiation therapy, UVB therapy, PUVA, photopheresis, systemic retinoids, systemic corticosteroids, interferon inducers, systemic chemotherapeutic agents\n  * Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia\n  * Participants who are receiving any other investigational agents\n  * Participants with uncontrolled intercurrent illness\n  * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n  * Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Pregnant women are excluded from this study because the effects of tofacitinib on the developing human fetus are unknown. As there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with tofacitinib, breastfeeding should be discontinued if the mother is treated with tofacitinib. These potential risks may also apply to other agents used in this study.","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL.",[25],"Cutaneous T-Cell Lymphoma","RECRUITING","2026-07-10",{"date":29,"type":30},"2026-07-13","ACTUAL",{"date":32,"type":30},"2025-03-10",{"date":34,"type":19},"2027-10-19",{"name":36,"class":37},"M.D. Anderson Cancer Center","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":20,"phases":47,"briefSummary":49,"conditions":50,"keywords":60,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":38},"100582251","combating-cancer-related-fatigue-a-personalized-supportive-care-program-100582251","NCT06860880","Combating Cancer-Related Fatigue: A Personalized Supportive Care Program","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.\n* Significant symptoms of fatigue, as defined by PROMIS Fatigue score \\>50.\n\nExclusion Criteria:\n\n* Other co-existing malignancies.\n* Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.\n* Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia\u002Fthrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.\n* Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention",{"count":46,"type":19},40,[48],"NA","This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.",[51,52,53,54,55,56,57,58,59],"Indolent Lymphomas","Lymphoma","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Lymphoplasmacytic Lymphoma","Waldenstrom Macroglobulinemia","Cutaneous T Cell Lymphoma",[61,62],"exercise","dietary intervention","2026-06-29",{"date":65,"type":30},"2026-07-01",{"date":67,"type":30},"2025-06-03",{"date":69,"type":19},"2026-12-31",{"name":71,"class":37},"UNC Lineberger Comprehensive Cancer Center",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":20,"phases":82,"briefSummary":84,"conditions":85,"keywords":95,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":38},"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":81,"type":19},60,[83],"PHASE1","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.",[86,87,88,89,90,91,92,25,93,94],"Relapsed and\u002For Refractory Mature T Cell Malignancy","Peripheral T-Cell Lymphoma","Angioimmunoblastic T-cell Lymphoma","Anaplastic Large Cell Lymphoma","Hepatosplenic T-cell Lymphoma","Monomorphic Epithelialtropic Intestinal Lymphoma","Enteropathy Associated T-cell Lymphoma","Mycosis Fungoides","Subacute Panniculitis-like T-cell Lymphoma",[96,97,98,99,100,101,102],"CCR4","CAR T","Chemokine Receptor 4","Chimeric Antigen Receptor","Gene Therapy","Cell Therapy","Immunotherapy","2026-06-24",{"date":105,"type":30},"2026-06-25",{"date":107,"type":30},"2025-09-29",{"date":109,"type":19},"2044-06-01",{"name":111,"class":112},"National Cancer Institute (NCI)","NIH",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":20,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100642007","phase-2-efficacy-and-safety-of-benvitimod-cream-in-cutaneous-t-cell-lymphoma-100642007","NCT07658924","Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma","Evaluation of the Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma","BEST-CTCL","Inclusion Criteria:\n\n* Patients diagnosed with cutaneous T-cell lymphoma (CTCL) \u002F mycosis fungoides (MF) by skin biopsy.\n* Aged 18 years or older.\n* Possess complete baseline clinical data.\n* Good compliance with treatment and willing to attend follow-up visits.\n* Conscious, with no cognitive impairment or communication barriers.\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, or those planning pregnancy within the next 6 months.\n* Known allergy or hypersensitivity to benvitimod cream or its excipients.\n* Severe ulceration or active infection at the target application sites.\n* Unwilling or unable to sign the informed consent form.",{"count":122,"type":19},35,[22],"Background:\n\nCTCL is a rare type of non-Hodgkin lymphoma that primarily affects the skin, causing red patches, plaques, and severe itching. Currently, topical corticosteroids are commonly used for early-stage disease, but long-term application can cause significant skin side effects such as atrophy. Benvitimod is a novel, non-steroidal aryl hydrocarbon receptor (AhR) agonist. Previous studies suggest it has the potential to inhibit tumor cell proliferation and reduce skin inflammation, providing a promising new targeted therapy for CTCL patients.\n\nStudy Design:\n\nThis is a prospective, single-center, double-blind, placebo-controlled study. To ensure a highly accurate comparison and eliminate individual differences, the study uses an intra-patient (left-right) control design. Approximately 35 patients will be enrolled.\n\nParticipants will have two comparable target lesions selected on opposite sides of their body (e.g., left and right trunk or limbs). They will be randomly assigned to apply benvitimod cream to the lesion on one side and a placebo cream to the matching lesion on the other side. The creams will be applied once daily for up to 24 weeks.\n\nResearchers will evaluate the improvement in skin lesions (using the mSWAT score), reduction in itching (using the VAS score), and closely monitor any adverse events at weeks 2, 4, 8, 16, and 24 to assess both the effectiveness and safety of the treatment.",[25,126],"Mycosis Fungoides (MF)",[128,129,130],"Benvitimod","Tapinarof","Topical Therapy","NOT_YET_RECRUITING","2026-06-16",{"date":134,"type":30},"2026-06-22",{"date":65,"type":19},{"date":137,"type":19},"2027-10-01",{"name":139,"class":37},"Peking University First Hospital",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":20,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":38},"100512714","phase-2-pembrolizumab-and-mogamulizumab-in-advanced-stage-relapsedrefractory-cutaneous-t-cell-lymphomas-100512714","NCT05956041","Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed\u002FRefractory Cutaneous T-cell Lymphomas","A Phase II Study of Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed\u002FRefractory Cutaneous T-cell Lymphomas","Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Age ≥ 18 years at the time of consent.\n* ECOG Performance Status of ≤ 1 within 7 days prior to Cycle 1 Day 1 treatment.\n* Histological confirmation of cutaneous T-cell lymphoma (Mycosis Fungoides\u002FSezary Syndrome) with Stage IIB-IVB disease (TNMB Classification).\n* Measurable disease according to Modified Severity Weighted Assessment Tool (mSWAT) within 30 days prior to treatment.\n* Patients must have measurable, unirradiated disease. Prior disease radiation, if greater than 7 days prior to C1D1, is acceptable (see protocol). However, patient must have measurable disease that has not been radiated.\n* Patients must have failed at least one prior line of systemic therapy. This includes ECP. Prior cancer treatment must be completed at least 28 days prior to Cycle 1 Day 1(C1D1) and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ grade 1 or baseline.\n* Archival tissue is required and will be identified at screening and shipped prior to C1D1 (10-15 unstained slides; obtained within 90 days of registration). Subjects that do not have archival tissue will be required to undergo a skin biopsy.\n* Systemic steroids at a dose less than the equivalent of 10 mg\u002Fday of prednisone and inhaled, nasal, and topical steroids are permitted. Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent in the absence of active autoimmune disease are permitted. Treatment with a short course of steroids (\\\u003C 5 days) up to 7 days prior to study registration is permitted.\n* Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to Cycle 1 Day 1.\n\n  * Hematological\n  * Absolute Neutrophil Count (ANC) ≥ 500\u002FµL\n  * Hemoglobin (Hgb) ≥ 8 g\u002FdL\n  * Platelet Count ≥ 25 000\u002FµL\n  * Renal\n\n    ---Creatinine OR Measured or calculated creatinine clearance1 ≤ 1.5 × ULN OR\n\n    ≥ 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 × institutional ULN\n  * Hepatic\n  * Bilirubin ≤ 1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN\n  * Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)\n  * Alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)\n  * Coagulation ---International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Females of childbearing potential must have a negative serum pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. See protocol for definition of childbearing potential.\n* Females of childbearing potential must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception as outlined in protocol. Males must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception as outlined in protocol.\n* Subjects with CNS disease are eligible so long as they meet all other eligibility criteria.\n* Patients must have a life expectancy of at least 6 months.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* Patients with a known history of Human Immunodeficiency Virus (HIV) infection are excluded. NOTE: No HIV testing is required unless mandated by local health authority.\n* Patients with concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. NOTE: Hepatitis B and C screening tests are not required unless: (1) Known history of HBV and HCV infection or (2) As mandated by local health authority.\n* Patients previously treated with checkpoint blockade, including pembrolizumab, or mogamulizumab, are excluded.\n* Patients who have received disease radiation therapy within 7 days of C1D1.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to Cycle 1 Day 1. Systemic steroids at a dose less than the equivalent of 10 mg\u002Fday of prednisone and inhaled, nasal, and topical steroids are permitted as detailed in protocol.\n* Has active or prior autoimmune disease or inflammatory disorders that have required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) with teh exception of vitiligo or alopecia. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years. NOTE: patients with non-melanoma skin cancers and in situ cancers that do not require systemic therapies are eligible.\n* Active infection requiring systemic therapy.\n* Prior allogeneic stem cell transplant or allogeneic cellular therapies, recent immunosuppressive therapies (for any reason).\n* Prior solid organ transplant.\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab or mogamulizumab and\u002For any of their excipients.\n* Treatment with any investigational drug or investigation device within 30 days prior to registration.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines and mRNA or inactivated COVID-19 vaccine is allowed.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.",{"count":148,"type":19},23,[22],"This is an open-label, single-arm, multicenter, phase II study combining pembrolizumab and mogamulizumab in patients with advanced-stage, relapsed or refractory CTCL Each cycle will equal 6 weeks. Pembrolizumab will be administered on Day 1 of each cycle. Mogamulizumab will be administered on Day 1, 8, 15, and 22 of Cycle 1. For Cycle 2 and subsequent cycles, mogamulizumab will be administered on Day 1, 15 and 29 of each cycle. Subjects will undergo a response assessment prior to Cycle 3 and every 2 cycles thereafter.\n\nSubjects will continue study treatment until documented progression, unacceptable toxicity, or any other condition for discontinuation is met in protocol. A maximum of 2 years of study treatment may be administered. If a subject achieves a complete response (CR) per mSWAT criteria after 3 months of study treatment (2 cycles), they will continue study therapy for an additional 6 months (4 cycles). If a confirmed and persistent CR is met, they may discontinue study treatment and enter an observation period in protocol. Repeat disease evaluation is required prior to study therapy discontinuation. Subjects who progress during the observation period may be eligible for up to an additional 9 cycles (1 year) of pembrolizumab and mogamulizumab.",[59,152],"Fungoides Mycosis Sezary Syndrome","2026-05-04",{"date":155,"type":30},"2026-05-05",{"date":157,"type":30},"2023-12-06",{"date":159,"type":19},"2027-12",{"name":161,"class":37},"University of Michigan Rogel Cancer Center",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":20,"phases":170,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":38},"100495261","early-phase-1-characterization-of-the-microbiome-in-cutaneous-t-cell-lymphoma-skin-lesions-before-and-after-use-of-apr-td011-rlf-td011-spray-solution-100495261","NCT05728879","Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution","Inclusion Criteria:\n\n* Adults with early-stage mycosis fungoides (stages IA-IB)\n* At least two target lesions that have been present for at least 3 weeks and is at least 10 cm2 , so that at least one lesion may be allocated to each of the treatment regimes\n* Target lesion with swab that is culture positive for staphylococcus aureus, but not to an extent that would require systemic antibiotics\n* Agree to avoid washing or using a topical application at the target lesion starting the night before each scheduled study visit.\n* Agree for the duration of study participation to avoid using dilute bleach or vinegar baths, or other antiseptic use, at the target lesion from screening throughout the study.\n\nExclusion Criteria:\n\n* Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics adults unable to provide informed consent, (infants, children, teenagers, pregnant women, prisoners and other vulnerable populations.",{"count":169,"type":19},30,[171],"EARLY_PHASE1","This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for the treatment of CTCL skin lesions.",[59],"2026-04-27",{"date":176,"type":30},"2026-05-01",{"date":178,"type":19},"2027-01",{"date":180,"type":19},"2028-12",{"name":182,"class":37},"Northwestern University",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":189,"sex":15,"minAge":16,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":193,"phases":4,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":38},"100357303","characterization-of-the-microbiome-in-cutaneous-t-cell-lymphoma-100357303","NCT03932279","Characterization of the Microbiome in Cutaneous T Cell Lymphoma","Inclusion Criteria:\n\n* Group 1: Patients with stage IA-IIA cutaneous T cell lymphoma\n* Group 2: Patients with stage IIB and above cutaneous T cell lymphoma\n* Group 3: Patients with CD30+ lymphoproliferative disorder including lymphomatoid papulosis and cutaneous anaplastic large cell lymphoma\n* Group 4: Patients with plaque psoriasis with BSA\\>5% on routine phototherapy per standard of care\n* Group 5: Patients with moderate to severe atopic dermatitis on routine bleach bath therapy per standard of care\n* Group 6: Healthy individuals without the above skin conditions, similar age and sex distribution to the patients with cutaneous T cell lymphoma\n* All Groups: subjects who are age 18-89 years of age at time of enrollment\n* All Groups: Subjects who are able and willing to give informed consent for this study and the Dermatology Tissue Acquisition and Biorepository (STU00009443).\n\nExclusion Criteria:\n\n* All Groups: Subjects who are younger than 18 years of age or older than 90 years of age\n* All Groups: Subjects who are unable to give consent\n* Patients currently on systemic antibiotics or recent (within past 4 weeks) exposure to systemic antibiotics\n* We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.",true,"89 Years",{"count":192,"type":19},300,"OBSERVATIONAL","Investigators plan to perform a pilot study that aims to characterize the microbiome of human cutaneous T cell lymphoma patients and compare this to the microbiome of age and sex matched controls.",[59],{"date":176,"type":30},{"date":198,"type":30},"2019-01-30",{"date":200,"type":19},"2028-08-31",{"name":182,"class":37},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":20,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":38},"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":210,"type":19},74,[22],"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.",[59,93],[215],"photopheresis","2026-04-22",{"date":174,"type":30},{"date":219,"type":30},"2021-05-08",{"date":221,"type":19},"2028-07",{"name":223,"class":37},"Columbia University",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":20,"phases":233,"briefSummary":234,"conditions":235,"keywords":243,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":38},"100620332","phase-2-ruxolitinib-maintenance-post-hematopoietic-stem-cell-transplant-t-cell-lymphoma-100620332","NCT07356245","Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma","Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma","Inclusion Criteria:\n\n1. Adult patients with T-cell lymphoma \\[PTCL (all subtypes), T-PLL, ATLL, and CTCL (all subtypes)\\] in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less\n3. Adequate hematologic function defined by absolute neutrophil count (ANC) \\> 1000\u002Fmm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets \\> 50K\u002Fmm3 without transfusion for at least 3 days and hemoglobin (Hb) \\> 8.0 g\u002FdL without transfusion for at least 3 days.\n4. Adequate organ function defined by total Bilirubin \\\u003C 1.5 x ULN, alanine aminotransferase (ALT) \\\u003C\u002F= 3 x ULN, CKD-EPI eGFR ≥ 30 ml\u002Fmin, SpO2 \\> 92% without supplemental oxygen.\n5. Able to tolerate oral or enteral medications.\n6. Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.\n7. Able to read and sign informed consent.\n\nExclusion Criteria:\n\n1. Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (\\\u003C2) in first complete remission.\n2. Progressive disease or any other systemic therapy post-SCT (radiation allowed)\n3. Disease progression to Ruxolitinib previously\n4. GvHD requiring systemic therapy.\n5. Active uncontrolled infections.\n6. Active thrombotic active microangiopathy requiring therapy.\n7. History of veno-occlusive disorder post-transplant\n8. Use of platelets antiaggregant or anticoagulants deemed to be unsafe to be held in case of thrombocytopenia.\n9. History of life-threatening bleeding defined as any bleeding that required invasive procedures or involving central nervous system.\n10. Pregnancy (positive Beta HCG test in a woman with childbearing potential defined as not postmenopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.\n11. Uncontrolled Hepatitis B\u002FC, HIV, tuberculosis, mycobacterium, or fungal infection.\n12. Exposure to other investigational drugs within 4 weeks before enrollment.\n13. Grade ≥ 3 non-hematologic toxicity from SCT that has not resolved to grade ≤ 2.\n14. Myocardial infarction or stroke within 1 year of study entry.\n15. Any uncontrolled medical problem at the discretion of the investigator that would pose a risk to the patient.",{"count":232,"type":19},44,[22],"This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The \"graft\" is the donor blood cells that patients get during the transplant. The \"host\" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.",[236,237,238,239,240,59,241,242],"T-cell Lymphoma","Graft Versus Host Disease","Lymphoma, T-Cell","Peripheral T Cell Lymphoma","T-cell Prolymphocytic Leukemia","Adult T-cell Leukemia\u002FLymphoma","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma",[244,245,246,247],"stem cell transplant","graft versus host disease","lymphoma","leukemia","2026-04-10",{"date":250,"type":30},"2026-04-15",{"date":252,"type":30},"2026-02-12",{"date":254,"type":19},"2027-01-31",{"name":256,"class":37},"Jonathan Brammer",{"id":258,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":20,"phases":260,"briefSummary":23,"conditions":261,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":265,"leadSponsor":267,"locationsCount":38},"100569790",{"count":18,"type":19},[22],[25],{"date":263,"type":30},"2026-04-14",{"date":32,"type":30},{"date":266,"type":19},"2026-10-19",{"name":36,"class":37},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":20,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":38},"100596624","phase-1-ropeginterferon-in-patients-wcutaneous-t-cell-lymphoma-ctcl-100596624","NCT07047885","Ropeginterferon in Patients w\u002FCutaneous T-Cell Lymphoma (CTCL)","A Phase I\u002FIB Study of Ropeginterferon in Patients With Cutaneous T-Cell Lymphoma (CTCL)","Inclusion Criteria:\n\n* Diagnosed with cutaneous T-cell lymphoma, stage IA-IIIB CTCL according to WHO-EORTC classification, specifically the following subtypes: Mycosis Fungoides (MF); Sézary Syndrome (SS); Lymphomatoid Papulosis (LyP) or other rare CTCL variants per WHO-EORTC classification, provided the investigator determines the disease course warrants systemic treatment.\n* A) For Stage IA-IB: Must have failed at least two prior lines of skin-directed therapy, where \"failed\" is defined as any of the following: a. Inadequate response (persistent clinically significant lesions or symptoms), b. Unacceptable toxicity, or c. Disease progression. Such patients require a systemic approach because of symptomatic, refractory, or recalcitrant disease. B) For Stage IIA-IIIB: Must have a documented less-than-complete response to phototherapy, extracorporeal photopheresis (ECP), or total skin electron beam therapy (TSET), or have failed disease after ≥2 lines of topical therapy (using the same definition of \"failed\" as above.\n* Patients are allowed to continue phototherapy or ECP at their prior schedule or a less frequent schedule. Topical therapy, phototherapy, and ECP are allowed if the patient has been on a stable dose of topical therapy or schedule of the phototherapy or ECP. Patients are not allowed to start new skin-directed therapies or escalate the frequency of the prior skin-directed therapy schedule while on the study.\n* Male or female, aged 18 years or older.\n* There is no evidence of large cell transformation on the skin biopsy at the screening visit.\n* Ability to take subcutaneous injection medication and be willing to adhere to the P1101 q2week injection regimen.\n* Minimum wash-out period of 3 weeks between the last dose of prior systemic therapy (other anti-cancer therapy aside from ECP or phototherapy) and the first dose of P1101.\n* Women of childbearing potential (WCBP) must have a negative serum beta-HCG pregnancy test within 7 days of receiving study medication. An WOCP is considered a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months. For WOCP and female partners of male subjects, reliable contraception methods must be used throughout the duration of treatment up to at least 8 weeks after the last dose of study drug has been administered.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Acceptable Hematologic Parameters\n* Thyroid-stimulating hormone (TSH) within institutional normal limits OR well-controlled on thyroid replacement.\n* Lipid Panel: a. No severe hypertriglyceridemia (e.g., triglycerides \\\u003C 400-500 mg\u002FdL, or medically manageable per investigator discretion). b. No uncontrolled hypercholesterolemia that is unresponsive to standard lipid lowering agents.\n* Renal Function: Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin using a CKD EPI.\n* AST\u002FALT \\\u003C 3 x upper limit of normal (ULN), and total bilirubin \\\u003C 2 x ULN (unless due to Gilbert's syndrome).\n\nExclusion Criteria:\n\n* Large cell transformation at screening visit.\n* Child-Pugh B or C hepatic impairment of any etiology.\n* Uncontrolled psychiatric disorders, defined as Patient Health Questionnaire-2 (PHQ-2) depression screening score equal to or above 3.\n* Treatment with another investigational drug or other systemic drug within 3 weeks. Concomitant administration of radiotherapy or systemic anti-cancer therapy, including but not restricted to chemotherapy, biological agents, or immunotherapy. Concurrent use of systemic steroids is allowed in patients with erythroderma who have been on corticosteroids to avoid possible rebound flare of the disease, adrenal insufficiency, or unnecessary suffering. Concomitant phototherapy or extracorporeal photopheresis (ECP) are also allowed.\n* Severe or unstable cardiovascular disease (uncontrolled hypertension, heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina, or recent stroke or myocardial infarction.\n* Active, uncontrolled HIV, detectable HBV, or active HCV infection. The patients who are stable on anti-retroviral therapy or suppressed on HBV\u002FHCV therapy are allowed in the study.\n* Active, uncontrolled ophthalmic disorders such as severe retinopathy, uncontrolled glaucoma, or advanced proliferative retinopathy.\n* History of or active serious or uncontrolled autoimmune disease, or patients on systemic immunosuppressants or history of systemic immunosuppressants for autoimmune disease.\n* History of solid organ or stem cell transplantation recipients who are at heightened risk for immunologic complications on interferons.\n* Known hypersensitivity to interferons.\n* Baseline QTcF \\> 470 ms.\n* No active, serious infection requiring systemic antimicrobial therapy at screening.\n* Pregnant or breastfeeding women are excluded.",{"count":276,"type":19},38,[83],"This is a single-center, phase I\u002FIB study to identify the recommended phase II dose of Ropeginterferon-alfa 2b (P1101) in patients with CTCL who have failed at least two prior lines of skin-directed therapy (Stage IA-IB) or have less than a complete response to phototherapy or extracorporeal photopheresis (ECP) or total skin electron beam therapy (TSET), or stable\u002Fprogressive disease after at least two lines of topical therapy (Stage IIA-IIIB).",[59],"2026-03-31",{"date":282,"type":30},"2026-04-01",{"date":284,"type":30},"2025-08-27",{"date":286,"type":19},"2028-06",{"name":288,"class":37},"H. Lee Moffitt Cancer Center and Research Institute",{"id":290,"slug":4,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":20,"phases":298,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":314},"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":297,"type":19},80,[299],"PHASE3","To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch\u002Fplaque phase cutaneous T-cell lymphoma (mycosis fungoides).",[302,303,93,59],"CTCL\u002F Mycosis Fungoides","CTCL","2026-03-30",{"date":306,"type":30},"2026-04-03",{"date":308,"type":30},"2025-01-07",{"date":310,"type":19},"2026-10",{"name":312,"class":313},"Soligenix","INDUSTRY",17,{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":20,"phases":323,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":340},"100462026","phase-1-a-study-of-bexarotene-combined-with-radiotherapy-in-people-with-mycosis-fungoides-100462026","NCT05296304","A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides","A Phase Ib Trial Combining Bexarotene With Ultra-Low Dose Total Skin Electron Beam (Tseb) Radiotherapy For The Treatment Of Diffuse Cutaneous T-Cell Lymphomas","Inclusion Criteria:\n\n* Age ≥18 years\n* Pathologically confirmed cutaneous T-cell lymphoma consistent with mycosis fungoides (MF) based on biopsy done or reviewed at MSKCC\n* Stage IB or higher MF per ISCL\u002FEORTC criteria; concurrent diagnosis of Sézary syndrome permissible. Patients who have not had prior systemic therapies and refractory\u002Frelapsed patients are eligible.\n* Baseline mSWAT score of at least 10\n* Stable topical steroids or systemic antipruritic agent (e.g. antihistamines, doxepin, GABA analogs) preceding study entry is permissible, but no new prescribed or over the counter topical or systemic anti-pruritics started post-enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Any oral retinoid therapy for any indication within 3 weeks of the first dose of study drug\n* Prior TSEB (prior focal skin-directed RT acceptable)\n* Concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL) or another non-Hodgkin lymphoma\n* Concurrent diagnosis of additional non-skin malignancy\n* Pregnancy\n* Patients unwilling to use two forms of barrier contraception while taking study medication\n* Receipt of treatment with another investigational device or drug (at present or within 2 weeks of enrollment)\n* Familial hypertriglyceridemia or other medical conditions in which use of bexarotene would be contraindicated\n* High likelihood of protocol non-compliance (in opinion of investigator)\n* Systemic steroids within two weeks of first dose of study drug (patients on systemic steroids for non-disease related conditions will be permitted per investigator discretion)\n\nProhibited concurrent medications\n\n* Gemfibrozil is contraindicated as may increase bexarotene concentrations\n* Bexarotene is a minor CYP3A4 substrate: avoid strong\u002Fmoderate CYP3A4 inducers and inhibitors, if possible, but concomitant use is not a contraindication Bexarotene is a moderate CYP3A4 inducer: avoid concurrent administration with CYP3A4 sensitive substrates, for which minimal concentration changes may lead to therapeutic failures of the substrate (e.g. cyclosporine, tacrolimus, sirolimus, quinidine, fentanyl), if possible",{"count":18,"type":19},[83],"The researchers are doing this study to test the safety of combining bexarotene with TSEB radiotherapy in people who have a common form of CTCL called mycosis fungoides (MF).\n\nBexarotene is a form of vitamin A that activates proteins called retinoid X receptors, which may stop the growth of cancer cells and kill them. TSEB radiotherapy is a type of radiation therapy that treats the entire surface of the skin with very low doses of radiation to kill cancer cells and shrink tumors. This type of radiation does not pass through the outer layers of the skin into the tissues and organs below the skin.\n\nThe study researchers think that giving bexarotene treatment at the same time as treatment with TSEB radiotherapy may be more effective against MF than either treatment given alone or in sequence (one after the other).",[326],"Cutaneous T-cell Lymphoma",[328,329,93,330],"Bexarotene","Radiotherapy","21-501","2026-02-03",{"date":333,"type":30},"2026-02-04",{"date":335,"type":30},"2022-03-16",{"date":337,"type":19},"2027-03",{"name":339,"class":37},"Memorial Sloan Kettering Cancer Center",3,{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":193,"phases":4,"briefSummary":350,"conditions":351,"keywords":355,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":38},"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":349,"type":19},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.",[326,352,93,353,354],"Sezary Syndrome","Eczema","Atopic Dermatitis",[326,352,93,356,357,358],"Blood\u002Ftissue banking","eczema","atopic dermatitis","2025-12-23",{"date":361,"type":30},"2025-12-30",{"date":363,"type":30},"2004-10",{"date":365,"type":19},"2032-01",{"name":367,"class":37},"University of Pittsburgh",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":193,"phases":4,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":396},"100561338","systemic-therapies-in-the-treatment-of-cutaneous-t-cell-lymphoma-100561338","NCT06588868","Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma","Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study","FIL_CTCL","Inclusion Criteria:\n\n* Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.\n* Age ≥18 years.\n* Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023.\n* Availability of complete medical records in order to provide protocol required variables\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients not meeting the above-mentioned inclusion criteria.\n* Refuse to sign a written informed consent.",{"count":377,"type":19},400,"The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.",[59,380,381],"Cutaneous T-Cell Lymphoma\u002FMycosis Fungoides","Cutaneous T-Cell Lymphoma\u002FSezary Syndrome",[59,93,383,384,385,386],"Sézary Syndrome","Retrospective","Systemic therapy","Real world","2025-12-01",{"date":389,"type":30},"2025-12-02",{"date":391,"type":30},"2025-02-27",{"date":393,"type":19},"2026-07",{"name":395,"class":37},"Fondazione Italiana Linfomi - ETS",18,{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":20,"phases":406,"briefSummary":407,"conditions":408,"keywords":416,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":428},"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":405,"type":19},48,[22],"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.",[238,409,410,59,411,412,413,414,415,93],"NK-LGL Leukemia","T-LGL Leukemia","Cutaneous T Cell Lymphoma (CTCL)","Large Granular Lymphocyte Leukemia","Large Granular Lymphocytic Leukemia","Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma",[417,418],"Indolent T\u002FNK-cell lymphomas","JAK1 inhibitor","2025-11-14",{"date":421,"type":30},"2025-11-18",{"date":423,"type":30},"2024-12-25",{"date":425,"type":19},"2028-11-15",{"name":427,"class":37},"Institute of Hematology & Blood Diseases Hospital, China",2,{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":20,"phases":438,"briefSummary":439,"conditions":440,"keywords":448,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":463},"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":437,"type":19},46,[83],"This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).",[236,441,442,443,444,445,326,446,88,447,93],"Cutaneous\u002FPeripheral T-Cell Lymphoma","Peripheral T-cell Lymphoma","Peripheral T-Cell Lymphoma, Not Classified","Primary Cutaneous T-cell Lymphoma","Cutaneous T-Cell Lymphoma, Unspecified","Follicular T-Cell Lymphoma","Sézary's Disease",[52,303,449,450,451,452,453],"Sézary syndrome","mycosis fungoides","PTCL","AITL","cALCL","2025-09-16",{"date":456,"type":30},"2025-09-22",{"date":458,"type":30},"2023-12-18",{"date":460,"type":19},"2027-05-01",{"name":462,"class":313},"SciTech Development, Inc.",10,{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":20,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":4},"100545716","phase-1-a-clinical-trial-in-adults-with-non-hodgkin-lymphoma-nhl-with-a-particular-emphasis-on-cutaneous-t-cell-lymphoma-ctcl-testing-the-safety-and-activity-of-a-novel-drug-to-inhibit-a-protein-called-tumor-necrosis-factor-receptor-2-that-drives-both-lymphoma-growth-and-escape-of-the-immune-system-100545716","NCT06385522","A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System","A Phase 1, First-In-Human, Open-Label, Dose-Escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Intravenous Doses of BITR2101 (Anti-TNFR2) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Including Cutaneous and Peripheral T Cell Lymphoma","Key Inclusion Criteria:\n\n* Histologically confirmed relapsed or refractory B cell NHL (DLBCL, MCL, MZL), PTCL or CTCL (MF or SS subtype) as per 2017 World Health Organization classification after at least 2 prior lines of systemic therapy and have received, or are not eligible for, approved or available treatments expected to provide benefit. CTCL patients should be Stage ≥1B through 4 and Stage 1A (see Appendix 1) with plaque disease without treatment options, in which case the patient should be discussed with the sponsor after submitting documentation of disease stage and treatment history. Patients with indolent lymphoid malignancies (CTCL, MZL) must need new treatment regimen in the opinion of the treating Investigator.\n* Age ≥18 years.\n* Life expectancy ≥3 months.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nKey Exclusion Criteria:\n\n* Patients with prior exposure (up to 12 months) to PD-1\u002FPD-L1 therapies.\n* Known hypersensitivity to any excipients that are used in the BITR2101 formulation as noted in Investigator Brochure.\n* Autoimmune diseases that have been sufficiently active to require medications in the 3 months before screening, except autoimmune endocrinopathies, such as hypothyroidism, that are stable with hormone-replacement therapy. Including inflammatory diseases such as arthritis, colitis, liver fibrosis, cirrhosis, interstitial fibrosis or chronic obstructive pulmonary disease (COPD). The SRC may allow patients with well controlled arthritis or COPD in the expansion cohort if there is no indication of inflammatory disease flare and no blood cytokine evidence of a systemic inflammatory response in the 3 months prior to enrollment.\n* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with participating in the protocol.\n* History or evidence of clinically significant cardiovascular disease.\n* Severe dyspnea, pulmonary dysfunction, or need for continuous supportive oxygen inhalation.\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study for the duration of this study or the FU period of an interventional study.\n* Prior or current anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy within 4 weeks of the first BITR2101 administration.\n* Continuous corticosteroid use exceeding 10 mg\u002Fday prednisone or equivalent.\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply",{"count":472,"type":19},37,[83],"The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year.",[476,59,442],"NHL","2025-07-04",{"date":479,"type":30},"2025-07-08",{"date":481,"type":19},"2025-08",{"date":483,"type":19},"2027-02",{"name":485,"class":313},"Boston Immune Technologies and Therapeutics",{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":193,"phases":4,"briefSummary":495,"conditions":496,"keywords":497,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":508,"locationsCount":38},"100545510","novel-flow-cytometry-approaches-to-improve-the-detection-of-tumor-cells-in-ctcl-100545510","NCT06382844","Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL","Design, Development, and Validation of Novel \"Next Generation Flow\" Approaches for Rapid, Specific, Sensitive, and Reproducible Detection of Tumor Cells in Cutaneous T-cell Lymphoma.","Inclusion Criteria:\n\n* Patients with cutaneous T-cell lymphoma\n* Over 18 years old\n* Sign the informed consent\n\nExclusion Criteria:\n\n* Under 18 years old\n* Do not sign the informed consent",{"count":494,"type":19},100,"Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)\u002FSézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF\u002FSS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination\u002Fprocedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and\u002For NGS, performed on cell populations previously sorted by flow cytometry).",[25],[52,498,499,500,501,449],"T Cell","Cutaneous","Flow cytometry","Mycosis fungoides","2025-04-29",{"date":504,"type":30},"2025-05-01",{"date":506,"type":30},"2024-01-01",{"date":69,"type":19},{"name":509,"class":37},"Instituto de Investigación Biomédica de Salamanca",{"id":511,"slug":512,"hasResults":11,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":517,"enrollmentInfo":518,"targetDuration":4,"studyType":20,"phases":519,"briefSummary":520,"conditions":521,"keywords":524,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":38},"100464874","morphee--mechanisms-of-cell-death-induced-by-extracorporeal-photochemotherapy-100464874","NCT05333367","MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy","MORPHEE","Inclusion Criteria:\n\n* Adult patients\n* Treated with ECP for at least 1 month, for control of GVHD in hematopoietic cell allograft (acute or chronic GVHD), treatment and control of cellular or humoral rejection in solid organ transplantation (heart, lung, kidney) or in the treatment of cutaneous T-cell lymphoma\n\nExclusion Criteria:\n\n* Subjects with limited legal capacity.\n* Subjects judged by the investigator to be unlikely to comply with study procedures\n* Subjects with no social security coverage.\n* Pregnant women.\n* Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.","85 Years",{"count":18,"type":19},[48],"The objective of this study is to describe the type of cell death induced by extracorporeal photochemotherapy, depending on the cell type, using a panel of complementary analysis techniques.",[25,522,523],"Graft Vs Host Disease","Graft Rejection",[525,526],"Cell death","Extracorporeal Photochemotherapy","2024-11-19",{"date":529,"type":30},"2024-11-21",{"date":531,"type":30},"2022-04-15",{"date":533,"type":19},"2025-07",{"name":535,"class":37},"Centre Hospitalier Universitaire de Besancon",{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":193,"phases":4,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":4},"100566132","evaluation-of-the-kir3dl2-marker-in-flow-cytometry-for-szary-syndrome-diagnosis-therapeutic-response-and-residual-disease-a-prospective-and-multicenter-study-100566132","NCT06651203","Evaluation of the KIR3DL2 Marker in Flow Cytometry for Sézary Syndrome Diagnosis, Therapeutic Response and Residual Disease: a Prospective and Multicenter Study","KISS01","Inclusion criteria for all patient :\n\n* Age ≥ 18\n* Patients with health insurance\n* Patients informed and not opposed to the study\n\nInclusion criteria for group 1 :\n\n\\- Patients with clinical features consistent with erythrodermic CTCL at initial diagnosis.\n\nInclusion criteria for group 2 :\n\n* Confirmed SS (previously diagnosed), followed at Saint Louis hospital participating center with all the following criteria:\n\n  1. Stage T4 erythroderma (stage (erythrodermia ≥ 80% of total body area)\n  2. The presence of an identical T-cell clone evidenced in blood and skin\n  3. B2 blood staging at initial diagnosis\n\n     Exclusion Criteria:\n* Other progressive neoplastic disease\n* Progressive psychotic disease\n* Patient under guardianship or curatorship\n* Patients with state medical aid\n* Refusal to participate",{"count":544,"type":19},460,"Cutaneous T-cell lymphomas (CTCL) are a group of primary cutaneous lymphomas including Mycosis Fungoides (MF) and Sézary syndrome (SS). SS is characterized by erythroderma and high numbers of circulating atypical lymphocytes (Sézary cells. SCs). Blood staging was added to the Tumor Node Metastasis (TNM) classification of MF\u002FSS, reflecting the broad spectrum of CTCLs and the poor prognosis related to blood involvement. Blood classes were defined using blood-smear manual counts. However, this method never reached an international consensus status because of its subjective nature and its poor sensitivity. Several markers have been identified with variable efficiency for MF\u002FSS diagnosis, outcome prediction and blood response to treatment. Such markers are essential for sharing and publishing consistent data about diagnosis, staging, prognosis and response to therapies. The detection of SCs is based on the lack of pan T-cell markers such as CD7 and\u002For CD26, which is not constant and may be observed in benign dermatoses. Thus, patients are often diagnosed with a delay, even treated with inappropriate therapies which worsens their prognosis. The relevance of blood-class in MF\u002FSS is not only related to stage but also contributes to the response to therapy in clinical trials. We found that a significant proportion of benign T-cells from SS patients are CD4+CD26-, which may underestimate the rate of complete response to treatment. The identification of KIR3DL2 on SCs by our team has greatly helped the detailed study of the malignant clone. We have recently published two ancillary studies demonstrating the specificity and reliability of KIR3DL2 as a positive marker for SCs, and its prognosis value at initial diagnosis. We have designed an optimized flow-cytometry strategy as part of the routine care of erythrodermic patients at Saint-Louis Hospital and published in 2019 the results of a 5 years prospective single-center study involving 254 CTCL patients at initial diagnosis. We provided recommendations with the use a threshold value of KIR3DL2+SCs ≥ 200\u002FµL or KIR3DL2+SCs\u002Flymphocytes ≥ 10% in the diagnostic criteria and proposed a novel algorithm blood staging.\n\nSeveral innovative immunotherapies in phase I\u002FII trials or under compassionate use are ongoing in French centers, with the need to assess blood response using positive markers. Our goal is to validate KIR3DL2 as a specific marker for SS and to assess its reliability for blood staging and response to treatment in a multicenter study (11 centers).",[547,59],"Mycosis Fungoides\u002FSezary Syndrome","2024-10-18",{"date":550,"type":30},"2024-10-21",{"date":552,"type":19},"2024-11-01",{"date":554,"type":19},"2029-11-01",{"name":556,"class":37},"Assistance Publique - Hôpitaux de Paris",{"id":558,"slug":559,"hasResults":11,"nctId":560,"briefTitle":561,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":20,"phases":564,"briefSummary":565,"conditions":566,"keywords":567,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":38},"100365992","a-pilot-of-a-microdevice-for-in-situ-candidate-drug-screening-in-cutaneous-lesions-of-t-cell-lymphoma-100365992","NCT04045470","A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma","Inclusion Criteria:\n\n* Participants must have clinical diagnosis of cutaneous T-cell lymphoma or peripheral T-cell lymphoma with cutaneous involvement supported by histological evaluation of skin lesions.\n* Participants must have measurable cutaneous disease, based on the modified Severity Weighted Assessment Tool (mSWAT; definition provided in appendix E). Skin lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Two lesions are amenable to placement of multiple devices in terms of lesion size and location, as assessed by dermatologist (minimum diameter of 1.5 cm).\n* Patient must have the following minimum washout period from previous treatments and cannot be on any systemic therapy at the time of implantation.\n\n  * 2 week from topical therapies of lesional skin selected for implantation\n  * 2 weeks from retinoids, interferons, vorinostat, romidepsin, therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteoids are allowed)\n  * 4 weeks from phototherapy\n  * 5 half-lives for systemic cytotoxic anticancer agents, monoclonal antibodies, and investigational therapy\n  * 12 weeks from local radiation therapy of lesional skin selected for implantation\n  * 15 weeks from systemic immunotherapy targeting PD-1\u002FPD-L1\n* Age minimum of age 18.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Participants will undergo laboratory testing within 28 days prior to the procedure. Participants must have marrow function as defined below:\n\n  * absolute neutrophil count ≥500\u002FmcL\n  * platelets ≥50,000\u002FmcL\n* Participants must be evaluated by a dermatologist or medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease. Systemic therapy will be mandatory for cohort 2\u002Fexpansion cohort, not for cohort 1. Systemic therapy may be initiated anytime within 4 weeks of MD removal.\n* Patients must be deemed medically stable to undergo percutaneous procedures by their treating cutaneous oncologist.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patients must be willing to undergo research-related genetic and transcriptomic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.\n* Patient is considered to have capacity to properly follow instructions at home for the care of device(s) that will each have an attached thin guidewire protruding through the skin and fixed in place (see Appendix B).\n\nExclusion Criteria:\n\n* Positive serum pregnancy test at screening visit.\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who will receive standard of care systemic therapy are not allowed to start any new skin directed therapy (e.g. topical steroids, radiation, phototherapy) concurrent with first systemic therapy initiated after device implantation and retrieval. Should a patient clinically progress on first systemic therapy and require a change in treatment, skin directed therapies may be introduced.\n* Patients unable to undergo treatment wash-out period due to rapidly progressive disease requiring immediate systemic therapy",{"count":18,"type":19},[48],"This research is being done to study the safety of implanting and retrieving a microdevice that releases up to 19 drugs directly within a cancerous lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against cutaneous T cell lymphoma and peripheral T cell lymphoma",[59,239],[59,239],"2024-10-07",{"date":570,"type":30},"2024-10-08",{"date":572,"type":30},"2019-12-11",{"date":574,"type":19},"2027-01-01",{"name":576,"class":37},"Dana-Farber Cancer Institute",{"id":578,"slug":579,"hasResults":11,"nctId":580,"briefTitle":581,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":583,"targetDuration":585,"studyType":193,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":38},"100363604","post-authorization-safety-study-of-allogeneic-hematopoietic-stem-cell-transplantation-in-patients-treated-with-mogamulizumab-100363604","NCT04014374","Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab","Inclusion Criteria:\n\n* Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)\n* Adults ≥18 years of age with either CTCL or ATLL;\n* AlloHCT performed from January 2012 onward.\n\nExclusion Criteria:\n\n• Patients without consent for research.",{"count":584,"type":19},150,"2 Years","This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.",[588,59,589],"Leukemia\u002FLymphoma","ATLL","2024-07-23",{"date":592,"type":30},"2024-07-24",{"date":594,"type":30},"2019-09-10",{"date":596,"type":19},"2030-02",{"name":598,"class":313},"Kyowa Kirin, Inc.",{"id":600,"slug":601,"hasResults":11,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":606,"enrollmentInfo":607,"targetDuration":585,"studyType":193,"phases":4,"briefSummary":608,"conditions":609,"keywords":610,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":340},"100549641","a-study-of-molecular-subtyping-based-therapeutic-strategies-for-cutaneous-t-cell-lymphoma-100549641","NCT06436677","A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma","AMITY","Inclusion Criteria:\n\n* Signed informed consent;\n* Patients with CTCL who do not respond well to targeted skin therapy (topical corticosteroids, nitrogen mustard, or phototherapy) in the early stage (stage I-IIA) and advanced stage (stage IIB-IV);\n* Age 18-75 years;\n* Expected survival time greater than 3 months (follow-up for the historical control group was greater than 3 months);\n\nExclusion Criteria:\n\n* Received other anti-tumor therapy other than skin-targeted therapy (phototherapy, topical hormones or nitrogen mustard) within the past 1 month prior to enrollment;\n* Patients with 2 or more types of primary cutaneous T-cell lymphoma at the same time;\n* Combined with other malignant tumors, still receiving anti-tumor therapy;\n* Has any other active disease that may increase the risk of protocol therapy or impair the patient\\'s ability to receive protocol therapy, including but not limited to:\n\n  * Comorbid epilepsy;\n  * Comorbid autoimmune diseases;\n  * Combined with hepatic decompensation;\n  * Patients with renal insufficiency and creatinine clearance \\< 50ml\u002Fmin;\n* Have an uncontrollable medical condition, including but not limited to:\n\n  * Ongoing or active infection;\n  * Clinically significant healing or non-healing wounds;\n  * Symptomatic congestive heart failure, unstable angina, clinically significant arrhythmias;\n  * Significant lung disease (e.g., shortness of breath at rest or light activity, or need for supplemental oxygen for any reason);\n  * Diseases\u002Fconditions that affect study compliance, such as infectious diseases or psychiatric illnesses\u002Fsocial situations, that are uncontrollable;\n* Pregnant (or intending to become pregnant within 2 years) or lactating females;\n* Concomitant participation in interventional clinical trials of other clinical trial drugs, except for questionnaire surveys or observational studies;\n* Any situation in which the programme is not in compliance;\n* Other conditions that in the opinion of the investigator are not suitable for participation in this study.","75 Years",{"count":494,"type":19},"Cutaneous T-cell lymphoma (CTCL) is a group of diseases resulting from clonal hyperplasia of memory T cells in the skin. The increasing incidence and high treatment costs have posed significant challenges to public health and the economy. Current treatment guidelines only provide partial control, leading to varying remission times and recurrence rates. This study aims to use molecular subtyping and immunohistochemistry to guide treatment selection for CTCL patients, aiming to prolong clinical benefit, improve treatment safety, and reduce economic burden.",[380,59],[611,450,612],"cutaneous T-cell lymphoma","Sezary syndrome","2024-05-24",{"date":615,"type":30},"2024-05-31",{"date":617,"type":30},"2024-05-09",{"date":619,"type":19},"2030-12-31",{"name":139,"class":37},{"id":622,"slug":623,"hasResults":11,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":20,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"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":630,"type":19},78,[299],"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.",[93,59],"2022-01-24",{"date":636,"type":30},"2022-01-25",{"date":638,"type":19},"2022-02",{"date":640,"type":19},"2031-02",{"name":556,"class":37}]