[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-t-cell-lymphoma-ctcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-t-cell-lymphoma-ctcl":176},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,83,116,139,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":4,"leadSponsor":44,"locationsCount":47},"100139553","collection-of-human-samples-to-study-hairy-cell-and-other-leukemias-and-to-develop-recombinant-immunotoxins-for-cancer-treatment-100139553",false,"NCT01087333","Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment","A Study of Hairy Cell and Other Leukemias With a Focus on Recombinant Immunotoxins for Cancer Treatment","* INCLUSION CRITERIA:\n\nAll participants\n\n* 18 years of age and older\n* Desire of the individual to submit data and samples for research\n* Ability to understand and the willingness to sign a written informed consent document.\n\nIndividuals with cancer\n\n-Participants may have a diagnosis of hematologic malignancy or solid tumor. These participants would not be excluded if they were in long-term complete remission.\n\nNormal donors (Individuals without cancer)\n\n-Individuals must not have a current or prior diagnosis of a hematologic malignancy or solid tumor.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n-Known pregnancy at enrollment. NOTE: A pregnancy test will be required in individuals on study prior to any procedure done for research purposes that is greater than minimal risk.",true,"ALL","18 Years",{"count":20,"type":21},1263,"ESTIMATED","OBSERVATIONAL","Background:\n\n\\- Researchers who are studying hairy cell leukemia, and how the disease compares with other disorders, are interested in obtaining additional samples from leukemia patients and healthy volunteers. The investigators are particularly interested in samples from individuals who have diseases that can be treated with a new type of drug called immunotoxin, in which an antibody carrying a toxin binds to a cancer cell and allows the toxin to kill the cell.\n\nObjectives:\n\n\\- To collect a variety of clinical samples, including blood, urine, lymph samples, and other tissues, in order to study the samples and develop new treatments for leukemia.\n\nEligibility:\n\n\\- Individuals 18 years of age and older who have been diagnosed with leukemia or other kinds of blood and lymphatic system cancers, or who are healthy volunteers.\n\nDesign:\n\n* Individuals who have leukemia will be asked to provide blood, bone marrow, urine, and tumor tissue samples as requested by the researchers. Healthy volunteers will provide only blood and urine samples.\n* No treatment will be given as part of this protocol.",[25,26,27,28,29],"Hairy Cell Leukemia (HCL)","Chronic Lymphocytic Leukemia (CLL)","Non-Hodgkins Lymphoma (NHL)","Cutaneous T Cell Lymphoma (CTCL)","Adult T Cell Lymphoma (ATL)",[31,32,33,34,35,36],"Cytotoxicity Assay","Neutralizing Antibodies","Apheresis","Flow Cytometry","Hemolytic Uremic Syndrome (HUS)","Natural History","RECRUITING","2026-06-04",{"date":40,"type":41},"2026-06-05","ACTUAL",{"date":43,"type":41},"2010-03-02",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100634132","phase-1-aclarubicin-plus-cyclophosphamide-vincristine-and-prednisone-caop-in-patients-with-previously-treated-cutaneous-t-cell-lymphoma-100634132","NCT07535710","Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma","A Multicenter, Open-Label, Phase 1\u002F2 Clinical Study of the Safety and Efficacy of Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form\n2. Age ≥ 60 years at enrollment\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n4. Histologically confirmed primary cutaneous T-cell lymphoma (CTCL) or Sézary syndrome (SS) (according to the fifth edition of the WHO Classification of Tumors of the Hematopoietic and Lymphoid System)\n5. Stage II-B, III, or IV (referring to the Olsen criteria of the International Society for Cancer Research (ISCL)\u002FUSCC\u002FEORTC, 2022)\n6. Patients who have failed at least one systemic therapy; psoralen combined with ultraviolet radiation therapy (PUVA) is not considered a systemic therapy\n7. All clinically significant toxicities caused by previous anticancer therapy have resolved to ≤ Grade 1 (according to NCI-CTCAE v5.0 criteria)\n8. Hematological, renal, and liver function tests meet the following requirements:\n\n   1. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002FμL\n   2. Platelet count ≥ 100,000 cells\u002FμL\n   3. For patients with known bone marrow involvement, ANC ≥ 1,000 cells\u002FμL and platelets ≥ 75,000 cells\u002FμL\n   4. Total bilirubin ≤ 1.5 times the institutional upper limit of normal (ULN) (except for patients with Gilbert syndrome)\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; if liver involvement is known in C TCL, ≤ 5.0 × ULN\n   6. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance calculated by the Cockcroft-Gault formula \\> 50 mL\u002Fmin\n\nExclusion Criteria:\n\n1. Patients diagnosed with a malignancy within the past two years. Exclude the following situation: non-melanoma skin cancer, melanoma in situ, localized prostate cancer (current PSA \\\u003C0.1 ng\u002FmL), treated thyroid cancer; or cervical carcinoma in situ or breast ductal\u002Flobular carcinoma in situ diagnosed within the past two years, as long as there is no current evidence of active disease.\n2. Clinical evidence of central nervous system (CNS) infiltration.\n3. Large cell transformation (LCT). Patients with a history of LCT but no current invasive disease and no evidence of LCT on skin or lymph node pathology may be enrolled.\n4. Psychiatric illness, disability, or social circumstances that may affect the subject's safety, ability to provide informed consent, or poor compliance.\n5. Patients with significant uncontrolled comorbidities or infections, as follows:\n\n   1. Uncontrolled infection requiring intravenous antibiotics\n   2. Clinically significant heart disease (New York Heart Association class III or IV), unstable angina\n   3. History of angioplasty, stent implantation, or myocardial infarction within 6 months\n   4. Uncontrolled hypertension despite treatment with two antihypertensive medications (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg, measured on two consecutive occasions, one week apart)\n   5. Clinically significant arrhythmias\n   6. Uncontrolled diabetes mellitus\n6. Known or tested positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B, or hepatitis C.\n7. Active herpes simplex or herpes zoster. Patients who have started antiviral prophylaxis ≥30 days prior to the pretreatment visit, have no signs of active infection, and whose last active infection occurred more than 6 months ago may be enrolled and must continue taking prescribed medications during the study.\n8. Known active autoimmune disease (e.g., Graves' disease, systemic lupus erythematosus, rheumatoid arthritis, Crohn's disease, psoriasis).\n9. Allergic reaction to study medications.\n10. History of allogeneic transplantation.\n11. Pregnancy (confirmed by β-hCG) or lactation.","60 Years",{"count":57,"type":21},37,"INTERVENTIONAL",[60,61],"PHASE1","PHASE2","Cutaneous T-cell lymphomas (CTCL) are a rare and heterogeneous group of extranidal T-cell lymphomas characterized by skin involvement. Current treatment options for CTCL are limited. Although responses have been demonstrated, their duration is often short, especially in patients with advanced stage disease. Additional treatment options are needed which demonstrate activity in cutaneous and extracutaneous sites. The traditional CHOP regimen (Cyclophosphamide, Hydroxydaunorubicin, Vincristine and Prednisone) has some efficacy for CTCL patients, but due to the cardiotoxicity of anthracyclines, patients can only receive a limited course of treatment. After stopping the regimen, most patients will experience relapse.\n\nAclarubicin, also known as aclacinomycin A, is an anthracycline type of antibiotic with significant anti-cancer properties. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. Aclarubicin's treatment indications include malignant lymphoma, but actual clinical application experience is limited.\n\nThe purpose of this study is to determine the maximum tolerated dose, safety and efficacy of aclarubicin combined with cyclophosphamide, vincristine, and prednisone (CAOP) for subjects with relapsed or refractory CTCL.",[64,65,66,28],"Cutaneous T-Cell Lymphoma Refractory","Cutaneous T-Cell Lymphoma, Relapsed","Sezary Syndrome",[68,69,66,70],"Aclarubicin","CTCL","systemic therapy","NOT_YET_RECRUITING","2026-04-14",{"date":74,"type":41},"2026-04-17",{"date":76,"type":21},"2026-03-30",{"date":78,"type":21},"2028-12-31",{"name":80,"class":81},"Shanghai Jiao Tong University School of Medicine","OTHER",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":58,"phases":92,"briefSummary":93,"conditions":94,"keywords":104,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":82},"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":91,"type":21},48,[61],"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.",[95,96,97,98,28,99,100,101,102,103],"Lymphoma, T-Cell","NK-LGL Leukemia","T-LGL Leukemia","Cutaneous T Cell Lymphoma","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","Mycosis Fungoides",[105,106],"Indolent T\u002FNK-cell lymphomas","JAK1 inhibitor","2025-11-14",{"date":109,"type":41},"2025-11-18",{"date":111,"type":41},"2024-12-25",{"date":113,"type":21},"2028-11-15",{"name":115,"class":81},"Institute of Hematology & Blood Diseases Hospital, China",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":58,"phases":125,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100609384","early-phase-1-a-phase-1-multicenter-open-label-prospective-first-in-human-dose-escalation-clinical-trial-of-domain-therapeutics-anti-ccr8-monoclonal-antibody-dt-7012-in-patients-with-relapsed-or-refractory-cutaneous-t-cell-lymphomas-ctcl-100609384","NCT07213882","A Phase 1, Multicenter, Open-label, Prospective, First-in-human Dose-escalation Clinical Trial of Domain Therapeutics' Anti-CCR8 Monoclonal Antibody (DT-7012) in Patients With Relapsed or Refractory Cutaneous T-cell Lymphomas (CTCL)","CITY","Inclusion Criteria:\n\n1. Adult Patients (≥18 years) with no upper age limit\n2. Confirmed diagnosis of mycosis fungoides or Sezary syndrome\n3. Stage IB to IVB in the ISCL \u002F EORTC classification\n4. Relapsed or refractory (no response) after at least two systemic treatments\n5. ECOG performance status 0-1\n6. Adequate liver function:\n\n   * Total bilirubin ≤ 1.5 xULN, or Direct bilirubin ≤ 1.5xULN if total bilirubin is \\>1.5xULN, or total bilirubin \\>1.5 xULN if elevated total bilirubin is attributed to Gilbert's syndrome or to histologically-proven liver involvement by CTCL\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2,5 x ULN, unless elevated to up to 5 x ULN due to CTCL\n7. Adequate hematological function:\n\n   * Absolute neutrophil count of ≥ 1.5 G\u002FL without G-CSF support for at least 7 days\n   * Platelet count of ≥ 75 G\u002FL without platelet transfusion within 7 days\n   * Hemoglobin ≥ 9 g\u002FdL without RBC transfusion within 7 days\n8. Adequate renal function: creatinine clearance calculated by Cockcroft \\& Gault formula of ≥ 50 mL\u002Fmin\n9. HBV: negative blood HBs Ag or blood HBV DNA. Vaccinated patients may be included. Patients with HBc antibody may be included if HBV DNA is negative\n10. HCV: negative HCV serology, or negative HCV RNA if HCV serology is positive\n11. HIV: negative HIV serology\n12. Negative serum or urinary pregnancy test within 7 days or at baseline prior to study treatment in women of childbearing potential\n13. Patients must agree to use a highly effective contraceptive method from inclusion until:\n\n    * If the patient is a male: at least 6 months after the last dose of DT-7012. Men must refrain from donating sperm during this same period\n    * If patient is a female of childbearing potential: at least 6 months after the last dose of DT-7012\n14. Patients must have the following minimum wash-out from previous treatments:\n\n    * 12 weeks for total skin electron beam irradiation,\n    * 4 weeks for monoclonal antibodies\n    * 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-neoplastic investigational agents\n    * 3 weeks for systemic retinoids, interferons, vorinostat, romidepsin, fusion proteins\n    * 3 weeks for phototherapy\n    * 2 weeks for topical therapy (including steroids, retinoids, nitrogen mustard or imiquimod). Topical steroids and oral steroids (10 mg prednisone equivalent\u002Fday maximum) are allowed, if the patient has been on a stable dose with stable symptoms for at least 4 weeks prior to study entry.\n15. Patient covered by any social security system (registered or being a beneficiary of such a scheme) for French participants only\n16. Signed informed consent\n\nExclusion Criteria:\n\n1. Known central nervous system involvement by CTCL\n2. Participation in any study of a health product within 30 days prior to study entry\n3. Patients with a history of other malignancies during the past three years (except for: non-melanoma skin cancer, lymphomatoid papulosis, curatively treated localized prostate cancer, curatively treated localized breast cancer, resected thyroid cancer, biopsy proven cervical intraepithelial neoplasia or cervical carcinoma in situ, which are not considered exclusion criteria).\n4. Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), or angina, myocardial infarction, cerebrovascular accident, transient ischemic attack within 6 months prior to study entry\n5. Any severe acute or chronic medical or psychiatric condition\n6. Patients with immunodeficiency\n7. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 1 week prior to first study drug dose\n8. Chronic use of systemic corticosteroids of prednisone or equivalent \\>10 mg prednisone equivalent\u002Fday for a chronic condition (washout of 8 days from start of treatment is accepted)\n9. Other immunosuppressive therapies are also excluded, (washout of 7 days from start of treatment is accepted)\n10. Autologous Hematopoietic Stem Cell Transplantation (HSCT) within 100 days prior to DT-7012 infusion\n11. Prior allogeneic HSCT\n12. Prior solid organ transplantation\n13. Patient with history of confirmed progressive multifocal leukoencephalopathy\n14. Known or suspected allergies, hypersensitivity, or intolerance to DT-7012 or its excipients\n15. Pregnant or breast-feeding woman, or desire (for both man and woman participant) to conceive a child within 6 months after end of treatment\n16. Patient under guardianship or curatorship and protected adults or unable to consent\n17. Coagulation disorder contra indicating intravenous infusion\n18. History of anaphylactic reaction following vaccination or immunotherapy\n19. History or current immune pneumonitis or interstitial lung disease",{"count":124,"type":21},30,[126],"EARLY_PHASE1","Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of lymphomas characterized by a primary involvement of the skin. Among them, mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes. SS is defined as erythroderma (erythema of the entire skin surface), and circulating tumor blood cells. The circulating tumor T cells express CD4 and may lose expression of CD7 and CD26, while exhibiting in most cases aberrant expression of CD158k (KIR3DL2), which is a surface marker of Sézary cells. CCR8 is a surface marker of tumor-infiltrating regulatory T cells. It has recently be observed that CCR8 was expressed by tumor cells in CTCL and other peripheral T-cell lymphomas. CCR8 is expressed by skin resident-memory T cells which are believed to be the tumor cell-of-origin in mycosis fungoides. Domain Therapeutics (DT) showed the in vitro efficacy of their proprietary anti-CCR8 mAb DT7012 in the depletion of CTCL cells. Therapeutic depletion of CCR8-expressing cells by DT-7012 could eliminate tumor cells and activate the anti-tumor immunity in CTCL. We hypothesize that treatment with DT-7012 is effective in the treatment of relapsed or refractory (R\u002FR) CTCL as advanced MF and SS.",[28,103,66],[98,103,66],"2025-10-02",{"date":132,"type":41},"2025-10-09",{"date":134,"type":21},"2026-01-01",{"date":136,"type":21},"2028-08-01",{"name":138,"class":81},"Assistance Publique - Hôpitaux de Paris",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":58,"phases":149,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100606661","phase-3-brentuximab-vedotin-in-cutaneous-t-cell-lymphomas-ctcl-post-allogeneic-hematopoietic-stem-cell-transplant-maintenance-100606661","NCT07178457","Brentuximab Vedotin in CutAneous T-cell Lymphomas (CTCL): Post-allogeneic Hematopoietic Stem Cell Transplant Maintenance","BeCALM","Inclusion Criteria:\n\nTo be eligible for study entry, patients must meet all of the following criteria:\n\n* Age ≥ 18 and ≤ 70 years\n* Histopathologically confirmed diagnosis of ISCL-EORTC stage IIB, III, IVA or IVB MF (mycosis fungoides) with ≥1% CD30 expression determined by immunohistochemistry\n* ECOG performance status 0-1\n* Relapsed or refractory to at least one line of systemic treatment\n* Complete or partial response of the lymphoma at the time of study inclusion\n* Having received recent alloHSCT from a sibling, 10\u002F10 or 9\u002F10 phenoidentical, or haploidentical donor (60 to 90 days before inclusion)\n* Adequate liver function:\n\n  * Total bilirubin ≤ 2 xULN, or Direct bilirubin ≤ 2xULN if total bilirubin is \\>2xULN, or total bilirubin \\>2 xULN if elevated total bilirubin is attributed to Gilbert's syndrome\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN\n* Adequate hematological function:\n\n  * Absolute neutrophil count of ≥ 1.0 G\u002FL\n  * Platelet count of ≥ 50 G\u002FL\n  * Hemoglobin ≥ 9 g\u002FdL\n* Adequate renal function: creatinine clearance calculated by Cockcroft \\& Gault formula of ≥ 50 mL\u002Fmin\n* Patient affiliated to life insurance\n* Written informed consent given by the patient\n\nExclusion Criteria:\n\nAny of the following criteria requires the exclusion of the patient before randomization:\n\n* Second or higher allogeneic HSCT,\n* Other progressive neoplastic or psychotic disease,\n* Left ventricular ejection fraction \\\u003C 50%, carbone monoxide diffusion capacity \\\u003C 50% of the theoretical value,\n* History of BV-induced adverse event without resolution to current grade \\\u003C2. Previous treatment with brentuximab vedotin alone, in the absence of current ≥ grade 2 BV-induced side effect, is NOT an exclusion criterion.\n* History of disease refractoriness, progression or relapse during BV treatment. Previous treatment with BV alone, if the disease was treatment-sensitive (complete, partial response or stable disease), is NOT an exclusion criterion.\n* History of ≥ grade 4 adverse event induced by BV. Previous \\\u003Cgrade 4 adverse event induced by BV is not an exclusion criterion if the adverse event has regressed to grade\\\u003C2.\n* Contra-indication to BV including current \\>grade 2 neutropenia or active infection,\n* Progressive disease or relapse at study inclusion compared to the screening visit status,\n* Refusal of highly effective birth control method for female participant of childbearing potential and male participant with a female partner of childbearing potential,\n* Pregnant and\u002For breastfeeding women,\n* Participation to another interventional clinical trial,\n* Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice),\n* Patients deprived of their liberty by a judicial or administrative decision","70 Years",{"count":148,"type":21},84,[150],"PHASE3","Allogeneic hematopoietic stem cell transplantation (alloHSCT) showed efficacy in advanced-stage, high-risk, treatment sensitive cutaneous T-cell lymphomas (CTCL) in a prospective, propensity score-matched controlled study (CUTALLO) published by our group in the Lancet in 2023. Nevertheless, it is associated with a high rate of early relapse, with 2-year progression-free survival around 30%. Brentuximab vedotin (BV) has shown efficacy in the treatment of CD30-expressing CTCL after at least one prior systemic treatment in the ALCANZA trial and is market approved in this indication in Europe and the United States of America. BV has been successfully used as salvage treatment in the post-transplant setting in advanced CTCL. It has been shown that 90% of CTCL express CD30. To reduce the incidence of post-allograft relapse, we propose to assess the routine use of BV post-allograft in adult patients with advanced CD30-expressing mycosis fungoides-CTCL, who have received at least one line of prior systemic therapy, compared to placebo. Switch will be allowed from placebo to BV in case of disease progression. This project is supported by well-organized research networks with a strong track-record of published results in the field: French Study Group on Cutaneous Lymphomas (GFELC, Groupe Français d'Etude des Lymphomes Cutanés), INCa-labelled national rare cancers network; and the French Society of Bone Marrow Transplantation and CellTherapy. In the post-transplant setting, the current state-of-the-art practice is to treat patients once they have relapsed post-allogeneic transplant, whereas no prophylactic treatment is given at the time in the absence of characterized disease relapse. This ethically and scientifically justifies the proposal to evaluate whether earlier, prophylactic treatment with BV increases progression-free survival compared to placebo.",[28,153],"Brentuximab Vedotin","2025-09-10",{"date":156,"type":41},"2025-09-17",{"date":158,"type":21},"2025-11-01",{"date":160,"type":21},"2032-11-01",{"name":138,"class":81},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":170,"targetDuration":4,"studyType":58,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":47},"100586335","phase-1-a-clinical-study-of-cht101-in-cd70-positive-relapsed-or-refractory-hematological-malignancies-100586335","NCT06914037","A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies","A Phase 1, Open-Label, Single-Arm Study of the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies","COURAGE","Inclusion Criteria (abbreviated):\n\n1. Willing and able to provide written informed consent.\n2. Aged 18 to 70 years, male or female.\n3. Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).\n4. Only the following subtypes of hematological malignancies with measurable disease will be enrolled:\n\n   1. Peripheral T cell lymphoma (including peripheral T cell lymphoma NOS, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, etc.) who have failed ≥1 line of systemic therapy.\n   2. Cutaneous T cell lymphoma (including mycosis fungoides (MF) or Sézary syndrome (SS) \\[stage ≥IIB with disease involving two or more compartments or single-compartment disease with large-cell transformation\\]) who have failed ≥2 lines of systemic therapies.\n   3. Aggressive B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody and anthracyclines.\n   4. Indolent B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody.\n   5. Chronic lymphocytic leukemia (CLL) who are refractory or relapsed post ≥2 lines of systemic therapies which contain BTK inhibitor and BCL-2 inhibitor.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n6. Estimated life expectancy ≥12 weeks.\n7. Female patients of childbearing potential and male patients must agree to use a highly effective method of contraception from signing ICF through 2 years after last CHT101 infusion.\n\nExclusion Criteria (abbreviated):\n\n1. History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.\n2. History of solid organ transplantation.\n3. Prior treatment with CD70-targeting agents.\n4. Prior treatment with CAR-T or other cellular\u002Fgene therapies.\n5. Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives.\n6. Active autoimmune disease requiring immunosuppression.",{"count":171,"type":21},24,[60],"Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies",[175,176,177],"Peripheral T-cell Lymphoma","Cutaneous T-cell Lymphoma (CTCL)","NHL (Non-Hodgkin Lymphoma)","2025-03-30",{"date":180,"type":41},"2025-04-06",{"date":182,"type":21},"2025-03-31",{"date":184,"type":21},"2028-03-31",{"name":186,"class":81},"Tianjin Medical University Cancer Institute and Hospital"]