[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-t-cell-lymphoma-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-t-cell-lymphoma-refractory":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100634132","phase-1-aclarubicin-plus-cyclophosphamide-vincristine-and-prednisone-caop-in-patients-with-previously-treated-cutaneous-t-cell-lymphoma-100634132",false,"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.","ALL","60 Years",{"count":19,"type":20},37,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27,28,29,30],"Cutaneous T-Cell Lymphoma Refractory","Cutaneous T-Cell Lymphoma, Relapsed","Sezary Syndrome","Cutaneous T Cell Lymphoma (CTCL)",[32,33,29,34],"Aclarubicin","CTCL","systemic therapy","NOT_YET_RECRUITING","2026-04-14",{"date":38,"type":39},"2026-04-17","ACTUAL",{"date":41,"type":20},"2026-03-30",{"date":43,"type":20},"2028-12-31",{"name":45,"class":46},"Shanghai Jiao Tong University School of Medicine","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100578398","phase-1-duvelisib-and-venetoclax-in-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma-ptcl-100578398","NCT06810778","Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","Phase I\u002FII Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","Inclusion Criteria:\n\n* Phase I: Histologically confirmed relapsed\u002Frefractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL).\n* Phase II: same as phase I\n* Disease that has progressed during or relapsed after at least two previous therapies.\n* ECOG performance status ≤ 2\n* Adequate hepatic function defined as:\n\n  o Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin\n* Adequate renal function as defined by:\n\n  o Creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection\n* Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement confirmed on biopsy:\n\n  * Absolute neutrophil count ≥ 1500 cells\u002Fmm3 (1.5 x 109\u002FL) or ≥ 1000 cells\u002Fmm3 (1.5 x 109\u002FL) with bone marrow involvement. Growth factor use is allowed in order to achieve this\n  * Platelet count ≥ 50,000 cells\u002Fmm3 (50 x 109\u002FL) independent of transfusion within 7 days of screening\n  * Hemoglobin ≥8 g\u002FdL (without transfusion support.)\n\nExclusion Criteria:\n\n* Phase I and Phase II:\n\n  * Patients eligible for Hematopoietic stem cell transplantation (HSCT)\n  * Cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL)\n  * Suspected and confirmed central nervous system involvement\n  * Previous treatment with venetoclax or a PI3K inhibitor.\n  * Active malignancy other than NHL requiring ongoing therapy, with the exception of hormonal therapy (i.e. castration-sensitive prostate cancer stable on testosterone blockade)\n  * Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery) within 2 weeks of Cycle 1\u002FDay 1 with the following exceptions:\n\n    * For patients on targeted therapies, a washout of least five half-lives is required\n    * Patients who experience clinical deterioration may start therapy after a shorter washout period with prior approval by the PI\n    * Corticosteroid therapy (prednisone or equivalent \\\u003C20 mg daily) is allowed\n    * Patients with multiple basal cell carcinomas that undergo sequential Moh's excisions with interim observation\n  * Allogeneic hematologic stem cell transplant within 6 months of starting study treatment or active graft vs. host disease (GVHD) requiring treatment or prophylaxis\n\n    o Patients with a history of an allogeneic stem cell transplant \\> 6 months prior to starting study treatment should be stable, off of immunosuppression for at least 2 months.\n  * Any active systemic infection requiring systemic antibiotics or other uncontrolled, active infections\n  * Positive Human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) antibody test\n\n    o For HCV and HBV, patients with evidence of prior infection also excluded\n  * Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n    * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate\n  * Uncontrolled, not disease-related autoimmune hemolytic anemia or ITP\n  * History of stroke or intracranial hemorrhage\n  * History of severe bleeding disorder (hemophilia A or B, von Willebrand disease (VWD)), history of spontaneous bleeding requiring blood transfusions or other medical intervention, history of life-threatening hemorrhage within 3 months of first dose.\n  * Currently active gastrointestinal disease, including colitis, inflammatory bowel disease and diarrhea requiring therapy\n  * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment\n  * Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina\n  * Use of Coumadin for anticoagulation (other anticoagulants permitted)\n  * Lactating or pregnant\n  * Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction resulting in malabsorption or chronic diarrhea\n  * Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A (see Appendix D)\n  * Treatment with any of the following within 7 days prior to the first dose of study drug:\n  * Steroid therapy for anti-neoplastic intent (defined as prednisone or equivalent \\>20 mg daily)\n  * Moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix D for examples)\n  * Moderate or strong CYP3A inducers (see Appendix D for examples)\n  * Administration or consumption of any of the following within 7 days prior to the first dose of study drug:\n\n    * Grapefruit or grapefruit products\n    * Seville oranges (including marmalade containing Seville oranges)\n    * Star fruit","18 Years",{"count":56,"type":20},12,[23,24],"This is an open-label, phase I\u002FII study of duvelisib in combination with Venetoclax for patients with relapsed\u002Frefractory NHL. Duvelisib is an FDA approved, marketed product used to treat certain patients with leukemia and lymphoma and Venetoclax, which is approved for treatment of certain patients with acute myeloid leukemia. The combination of these two drugs is experimental. Experimental means that it is not approved by the United States Food and Drug Administration (FDA). The researchers want to find out how safe it is to combine these drugs and how well this combination can work for your cancer.",[60,27],"T-cell-prolymphocytic Leukemia",[62,63,64],"leukemia","refractory","relapsed","RECRUITING","2025-07-11",{"date":68,"type":39},"2025-07-15",{"date":70,"type":39},"2025-05-02",{"date":72,"type":20},"2031-06-01",{"name":74,"class":46},"Jonsson Comprehensive Cancer Center",1]