[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-cutaneous-t-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-cutaneous-t-cell-lymphoma":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":55,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100514411","a-registry-for-people-with-t-cell-lymphoma-100514411",false,"NCT05978141","A Registry for People With T-cell Lymphoma","The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens","Inclusion Criteria:\n\n* Written informed consent\n* Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy.\n* Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines):\n\n  * T-cell prolymphocytic leukemia\n  * T-cell large granular lymphocytic leukemia\n  * Chronic lymphoproliferative disorder of NK cells\n  * Aggressive NK-cell leukemia\n  * Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood\n  * Chronic active EBV infection of T- and NK-cell type, systemic form\n  * Hydroa vacciniforme-like lymphoproliferative disorder\n  * Adult T-cell leukemia\u002Flymphoma\n  * Extranodal NK\u002FT-cell lymphoma, nasal type\n  * Enteropathy-associated T-cell lymphoma\n  * Monomorphic epitheliotropic intestinal T-cell lymphoma\n  * Intestinal T-cell lymphoma, not otherwise specified (NOS)\n  * Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract\n  * Hepatosplenic T-cell lymphoma\n  * Subcutaneous panniculitis-like T-cell lymphoma\n  * Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy)\n  * Sézary syndrome\n  * Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy)\n  * Primary cutaneous Gamma-Delta T-cell lymphoma\n  * Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma\n  * Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy)\n  * Peripheral T-cell lymphoma, not otherwise specified\n  * Angioimmunoblastic T-cell lymphoma\n  * Follicular T-cell lymphoma\n  * Nodal peripheral T-cell lymphoma with TFH phenotype\n  * Anaplastic large cell lymphoma, ALK-positive\n  * Anaplastic large cell lymphoma, ALK-negative\n  * Breast-implant associated anaplastic large cell lymphoma.\n* NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy.\n\nExclusion Criteria:\n\n* Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy.\n* Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.","ALL",{"count":18,"type":19},1000,"ESTIMATED","10 Years","OBSERVATIONAL","The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"T-cell Lymphoma","NK-Cell Lymphoma","T-cell Prolymphocytic Leukemia","T-cell Large Granular Lymphocytic Leukemia","Chronic Lymphoproliferative Disorder of NK Cells","Aggressive NK-cell Leukemia","Systemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder)","Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood","Chronic Active EBV Infection of T-and NK-Cell Type, Systemic Form","Hydroa Vacciniforme-Like Lymphoproliferative Disorder","Adult T-cell Leukemia\u002FLymphoma","Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Enteropathy-associated T-cell Lymphoma","Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma","Intestinal T-Cell Lymphoma, Not Otherwise Specified","Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","Hepatosplenic T-cell Lymphoma","Subcutaneous Panniculitis-Like T-Cell Lymphoma","Mycosis Fungoides","Sezary Syndrome","Primary Cutaneous Anaplastic Large Cell Lymphoma","Primary Cutaneous T-cell Lymphoma","Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma","Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Angioimmunoblastic T-cell Lymphoma","Follicular T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-negative","Breast Implant-Associated Anaplastic Large Cell Lymphoma",[56,57,58,59,60],"23-190","T-cell lymphoma","Memorial Sloan Kettering Cancer Center","T-cell Lymphoma Master Repository","TCLMR","RECRUITING","2026-05-18",{"date":64,"type":65},"2026-05-20","ACTUAL",{"date":67,"type":65},"2023-07-27",{"date":69,"type":19},"2030-07-27",{"name":58,"class":71},"OTHER",26,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"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.","18 Years",{"count":82,"type":19},46,"INTERVENTIONAL",[85],"PHASE1","This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).",[24,88,89,90,45,91,92,50,49,93,42],"Cutaneous\u002FPeripheral T-Cell Lymphoma","Peripheral T-cell Lymphoma","Peripheral T-Cell Lymphoma, Not Classified","Cutaneous T-Cell Lymphoma, Unspecified","Cutaneous T-cell Lymphoma","Sézary's Disease",[95,96,97,98,99,100,101],"Lymphoma","CTCL","Sézary syndrome","mycosis fungoides","PTCL","AITL","cALCL","2025-09-16",{"date":104,"type":65},"2025-09-22",{"date":106,"type":65},"2023-12-18",{"date":108,"type":19},"2027-05-01",{"name":110,"class":111},"SciTech Development, Inc.","INDUSTRY",10]