[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mycosis-fungoidessezary-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mycosis-fungoidessezary-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100646832","phase-2-golidocitinib-in-patients-with-mycosis-fungoidesszary-syndrome-and-t-cell-large-granular-lymphocytic-leukemia-100646832",false,"NCT07682792","Golidocitinib in Patients With Mycosis Fungoides\u002FSézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia","A Pilot Study of Golidocitinib, a JAK1 Inhibitor, in Patients With Mycosis Fungoides\u002FSézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia (GEMSTONE)","GEMSTONE","Inclusion Criteria for MF\u002FSS:\n\n* Histologically or cytologically confirmed mycosis fungoides or Sézary syndrome, stages IB to IVB with measurable disease and\u002For detectable blood involvement based on the Global Response Criteria for CTCL\n* Received at least one prior line of systemic therapy.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate counts and organ function as defined below:\n\n  * Platelet count \\> 75 K\u002Fcumm, unless related to lymphoma, in which case platelet count must be \\> 50 K\u002Fcumm. Platelet transfusion may be utilized to meet inclusion criteria, as long as the platelet count remains at the above threshold without transfusion for 5 days.\n  * Serum Creatinine ≤ 2 x IULN\n  * Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin using the Modification of Diet in Renal Disease (MDRD) equation (multiplying eGFR by each subject's Body Surface Area \\[BSA\\])\n  * Serum total bilirubin ≤ 1.5 x IULN if no liver involvement, or ≤ 2 x IULN in the presence of Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver involvement.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x IULN, or ≤ 5 x IULN if documented hepatic involvement with lymphoma.\n* Patients must be able to swallow pills.\n* The effects of golidocitinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use highly effective methods of contraception for the duration of study participation and for 3 months after the last dose of golidocitinib for female patients and female partners of male patients, or for 6 months after the last dose of golidocitinib for male patients and male partners of female patients. Should a woman become pregnant or suspect she is pregnant or a male patient suspect he has impregnated another while participating in this study, s\u002Fhe must inform the treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nInclusion Criteria for LGLL\n\n-Diagnosis of T-LGLL defined as: CD3+CD8+ cell population \\> 650\u002Fmm3 or CD3+CD8+CD57+ population \\> 500\u002Fmm3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis).\n\nNote: patients with MDS-like T-LGLL may be included with PI approval even if CD3+CD8+ cell population is \\\u003C 650\u002Fmm3, though +TCR is required. Natural-Killer (NK) LGL is also permitted, provided there is a clonal NK-cell population noted with \\> 500 cells\u002Fmm3.\n\n* Untreated T-LGLL or failed at least one line of frontline therapy.\n* Patients must require treatment for T-LGLL, as defined by meeting one or more of the below criteria:\n\n  * Symptomatic anemia with hemoglobin \\\u003C 10 g\u002FdL\n  * Transfusion-dependent anemia\n  * Neutropenia with absolute neutrophil count (ANC) \\\u003C 0.5 K\u002Fcumm\n  * Neutropenia with ANC \\\u003C 1.5 K\u002Fcumm with recurrent infections\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate counts and organ function as defined below:\n\n  * Platelet count \\> 50 K\u002Fcumm. Platelet transfusion may be utilized to meet inclusion criteria, as long as the platelet count remains \\> 50 K\u002Fcumm within 5 days of last transfusion.\n  * Serum Creatinine ≤ 2 x IULN\n  * Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin using the Modification of Diet in Renal Disease (MDRD) equation (multiplying eGFR by each subject's Body Surface Area \\[BSA\\])\n  * Serum total bilirubin ≤ 1.5 x IULN if no liver involvement, or ≤ 2 x IULN in the presence of Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver involvement.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x IULN, or ≤ 5 x IULN if documented hepatic involvement with T-LGLL.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression.\n* Patients must be able to swallow pills.\n* The effects of golidocitinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use highly effective methods of contraception for the duration of study participation and for 3 months after the last dose of golidocitinib for female patients and female partners of male patients, or for 6 months after the last dose of golidocitinib for male patients and male partners of female patients. Should a woman become pregnant or suspect she is pregnant or a male patient suspect he has impregnated another while participating in this study, s\u002Fhe must inform the treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria for MF\u002FSS:\n\n* Patients with active CNS lymphoma.\n* A history of other malignancy, with the exception of 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* Currently receiving any other investigational agents.\n* Concomitant use of another systemic therapy for MF\u002FSS. Patients must have the following minimum washout from previous treatments:\n\n  * At least 8 weeks for low-dose (12 Gy or less) total skin electron beam therapy (TSEBT).\n  * At least 4 weeks for systemic cytotoxic anticancer agents or for tumor-targeting monoclonal antibodies (mAbs), with the exception of alemtuzumab, for which the washout is at least 16 weeks.\n  * At least 2 weeks or 5 half-lives (whichever is shorter) for systemic retinoids, interferons, vorinostat, romidepsin, and denileukin diftitox, or anticancer investigational agents that are not defined as immunotherapy.\n  * At least 1 week for topical retinoids, nitrogen mustard, or imiquimod.\n* Gastrointestinal disorders, or any other condition that may significantly interfere with absorption of the study medication by the investigator's assessment.\n* Uncontrolled active infection requiring IV antibiotic, antiviral, or antifungal medications within 14 days before the first dose of study drug. Infections (e.g., urinary tract infection) controlled on concurrent antimicrobial agents and antimicrobial prophylaxis per institutional guidelines are acceptable.\n* Current known active or chronic infection with HIV, hepatitis B, or hepatitis C. All patients will require serologic testing to be performed within 6 months prior to C1D1.\n\n  * Patients with chronic HBV are defined as patients with positive hepatitis B serology: Patients with a negative HBsAg and a positive HBcAb require an undetectable\u002Fnegative hepatitis B DNA test (e.g. polymerase chain reaction \\[PCR\\] test) to be enrolled and will require prophylactic antiviral treatment initiated prior to the first dose of study drug, and continued until approximately 6 to 12 months after completion of study drug(s).\n  * Patients with chronic HCV infection are defined as patients with a positive hepatitis C antibody (anti-HCV) test:\n  * Patients with a positive anti-HCV antibody test require a quantitative HCV RNA viral load test (e.g., polymerase chain reaction \\[PCR\\] test) to determine eligibility. Patients with a positive anti-HCV antibody and a detectable\u002Fpositive HCV RNA (i.e., active chronic HCV infection) are not eligible.\n  * Patients with a positive anti-HCV antibody and an undetectable\u002Fnegative HCV RNA (i.e., prior resolved infection or previously treated and cured HCV) are eligible for enrollment without antiviral treatment.\n* Unstable or severe uncontrolled medical condition or any important medical or psychiatric illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his\u002Fher participation in this study.\n* Pregnant and\u002For breastfeeding.\n* Concurrent immune-suppressive therapy exceeding prednisone 20 mg equivalent.\n\nExclusion Criteria for LGLL\n\n* Patients with active CNS involvement with T-LGLL.\n* A history of other malignancy with the exception of 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* Currently receiving any other investigational agents, or receipt of another systemic therapy for T-LGLL within 14 days or 5 half-lives of the first dose of golidocitinib, whichever is shorter.\n* Gastrointestinal disorders, or any other condition that may significantly interfere with absorption of the study medication by the investigator's assessment.\n* Uncontrolled active infection requiring IV antibiotic, antiviral, or antifungal medications within 14 days before the first dose of study drug. Infections (e.g., urinary tract infection) controlled on concurrent antimicrobial agents and antimicrobial prophylaxis per institutional guidelines are acceptable.\n* Current known active or chronic infection with HIV, hepatitis B, or hepatitis C. All patients will require serologic testing to be performed within 6 months prior to C1D1.\n\n  * Patients with chronic HBV are defined as patients with positive hepatitis B serology: Patients with a negative HBsAg and a positive HBcAb require an undetectable\u002Fnegative hepatitis B DNA test (e.g. polymerase chain reaction \\[PCR\\] test) to be enrolled and will require prophylactic antiviral treatment initiated prior to the first dose of study drug, and continued until approximately 6 to 12 months after completion of study drug(s).\n  * Patients with chronic HCV infection are defined as patients with a positive hepatitis C antibody (anti-HCV) test: Patients with a positive anti-HCV antibody test require a quantitative HCV RNA viral load test (e.g., polymerase chain reaction \\[PCR\\] test) to determine eligibility. Patients with a positive anti-HCV antibody and a detectable\u002Fpositive HCV RNA (i.e., active chronic HCV infection) are not eligible. AND Patients with a positive anti-HCV antibody and an undetectable\u002Fnegative HCV RNA (i.e., prior resolved infection or previously treated and cured HCV) are eligible for enrollment without antiviral treatment.\n* Unstable or severe uncontrolled medical condition or any important medical or psychiatric illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his\u002Fher participation in this study.\n* Pregnant and\u002For breastfeeding.","ALL","18 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, single-institution pilot study of single-agent golidocitinib enrolling up to 24 patients in two cohorts: a) advanced-stage mycosis fungoides\u002FSézary syndrome (MF\u002FSS), n=12, or b) T-cell large granular lymphocytic leukemia (T-LGLL) requiring treatment, n=12. Patients will receive single agent golidocitinib at the previously established dose of 150 mg QD as determined in the phase I and II studies of golidocitinib.",[27,28],"Mycosis Fungoides\u002FSezary Syndrome","T-cell Large Granular Lymphocytic Leukemia",[30,31,32],"JAK inhibitor","Golidocitinib","Cutaneous T-cell lymphoma","NOT_YET_RECRUITING","2026-06-26",{"date":36,"type":37},"2026-07-06","ACTUAL",{"date":39,"type":21},"2026-09-30",{"date":41,"type":21},"2032-09-30",{"name":43,"class":44},"Washington University School of Medicine","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"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":54,"type":21},460,"OBSERVATIONAL","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).",[27,58],"Cutaneous T Cell Lymphoma","2024-10-18",{"date":61,"type":37},"2024-10-21",{"date":63,"type":21},"2024-11-01",{"date":65,"type":21},"2029-11-01",{"name":67,"class":44},"Assistance Publique - Hôpitaux de Paris"]