[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Won Seog Kim\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100475925","phase-2-concurrent-tislelizumab-and-radiotherapy-in-newly-diagnosed-extranodal-nkt-cell-lymphoma-nasal-type-100475925",false,"NCT05477264","Concurrent Tislelizumab and Radiotherapy in Newly Diagnosed Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Phase II Study of Concurrent Tislelizumab and Radiotherapy for Treatment-naïve, Newly Diagnosed Low-risk Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Inclusion Criteria:\n\n1. Histologicallly diagnosed extranodal NK\u002FT-cell lymphoma\n2. No history of prior treatment\n3. Stage IE\u002FIIE(cases involving the nasal cavity, nasopharynx, and oral cavity only)\n4. International prognostic index(PINK, PINK-E risk score): 0-1\n5. 19 years and older\n6. ECOG PS: 0-2\n7. AT least one measurable and assessable lesion at least 1.5cm in size on CT or PET\u002FCT scan\n8. Adequate bone marrow function, as defined by the following laboratory values(If cytopenia is associated with bone marrow involvement, the subject is excluded):\n\n   * Absolute neutrophil \\> 1,500\u002Fmm3\n   * Hemoglobin \\> 9.0g\u002FdL\n   * Platelet \\> 75,000\u002Fmm3\n9. Adequate organ function, as defined by the following laboratory values\n\n   * Total bilirubin, AST\u002FALT \\\u003C 3xULN\n   * Serum creatinine ≤ 2.0mg\u002FdL\n10. Voluntary written informed consent to undergo chemotherapy and radiotherapy\n11. Female subjects are required to meet the following criteria:\n\n    * Pregnancy test: For women of childbearing potential, a negative serum or urine pregnancy test at screening\n    * Contraception: For both male and female subjects, use of highly effective contraception throughout the study period and, if at risk of pregnancy, for at least 6 months after the last dose of the study treatment\n12. Having tumor tissue sample in storage available for targeted sequencing\n\nExclusion Criteria:\n\n1. History of prior treatment(chemotherapy, radiotherapy, or targeted therapy) to treat extranodal NK\u002FT-cell lymphoma\n2. Stage III\u002FIV at diagnosis or stage IE-IIE with extranodal(cutaneous, soft tissue, gastrointestinal, brain, spinal cord, bone marrow, etc.)\n3. International prognostic index(PINK, PINK-E): ≥ 2\n4. Has a concomitant malignancy or had a malignancy(except for appropriately treated basal or squamous cell carcinoma or cervical carcinoma in situ) in the last 3 years prior to initiation of the study treatment\n5. Underwent a major surgery within 21 days prior to initiating the study treatment, or has not recovered from serious side effects of surgery\n6. Concomitant use of immunosuppressants, except for the following:\n\n   * Intranasal, inhaled, or topical steroid, or local steroid injection(such as intra-articular injection)\n   * Physiological dose ≤ 10mg\u002Fday of prednisone or equivalent doses of systemic corticosteroid\n   * Premedication with steroids to prevent hypersensitivity reaction(such as premedication prior to a CT scan). At the discretion of the investigator, the use of prednisolone at ≥ 10mg for adrenal insufficiency may be acceptable\n7. Clinically significant, or active, cardiovascular disease\n\n   * Cerebrovascular accient\u002Fstroke: within 6 months prior to study entry\n   * Myocardial infarction: within 6 months prior to study entry\n   * Unstable angina, congestive heart failure(New York Heart Association class ≥II), or serious cardiac arrhythmias requiring medication, including any of the following\n\n     * Left ventricular ejection fraction(LVEF) \\\u003C 50% as measured by echocardiography\n     * QTc\\>480msec(using the QTcF formula) on ECG at screening\n     * unstable angina\n     * ventricular arrhythmias except for benign premature ventricular contraction\n     * medically uncontrolled supraventricular and nodal arrhythmias\n     * conduction abnormality requiring a pacemaker\n     * valve disease with documented cardiac dysfunction\n8. Other concomitant severe and\u002For uncontrolled medical conditions(e.g., uncontrolled diabetes mellitus, chronic pancreatitis, active chronic hepatitis, etc.) that the investigator considers would preclude the subjects's participation in the clinical trial. Other severe acute or chronic medical conditions include colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, or psychiatric conditions, including recent(in the last 1 year) or active suicidal thoughts or behaviors: or laboratory abnormalities the, in the investigator's opinion, may increase the risk associated with participation in the clinical trial or study treatment, or that may interfere with the interpretation of clinical trial results.\n9. Active infection requiring ststemic therapy\n10. Active autoimmune disease that may be exacerbated upon administration of immunostimulants. However, subjects with type I diabetes mellitus, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism not requiring immunosuppressive treatment are eligible\n11. Incapable of understanding or complying with clinical trial instructions and requirements, or have a history of noncompliance with medical therapy\n12. Pregnant or nursing(breastfeeding) women. Pregnancy is defined as the condition of a woman form pregnancy as confirmed by positive serum hCG laboratory test(\\>5mIU\u002FmL) to termination of pregnancy.\n13. Live vaccination is prohibited, except for influenza and COVID vaccines are allowed, within 2 weeks prior to the first dose of tislelizumab and during clinical trial participation, and inactivated vaccines are allowed.\n14. Hepatitis B virus(HBV) related liver disease, such as the following:\n\n    * Chronic hepatitis with cirrhosis\n    * HBV reactivation(However, hepatitis B surface antigen positive subjects who are asymptomatic and do not require treatment can be enrolled at the discretion of the investigator)\n    * Hepatitis B virus(HBV) infection at screening(HBV surface antigen-positive and HBV DNA positive)\n    * Hepatitis C virus(HCV) infection at screening(HCV RNA positive if positive for anti-HCV antibody at screening)","ALL","19 Years",{"count":19,"type":20},38,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This clinical trial intends to analyze the efficacy of PD-1 inhibitor combined with radiotherapy for newly diagnosed NK\u002FT-cell lymphoma. The investigational product in this clinical trial is tislelizumab, a PD-1 inhibitor.\n\nAs a rationale for using PD-1 inhibitors in patients with NK\u002FT-cell lymphoma, their efficacy has been proved several times mostly in patients with relapsed NK\u002FT-cell lymphoma.\n\nPatients with low-stage NK\u002FT-cell lymphoma usually receive high-concentration cytotoxic chemotherapy combined with radiotherapy, with treatment response rates of approximately 60 to 80%, but 80-90% of them experience hematological and non-hematologic toxicities during treatment.\n\nTherefore, this study intends to determine the efficacy and safety of PD-1 inhibitor(Tislelizumab) combined with radiotherapy as a first-line therapy compared with pre-existing cytotoxic chemotherapy combined with radiotherapy in patients with NK\u002FT-cell lymphoma with low stage and International Prognostic Index.",[26],"Lymphoma","RECRUITING","2024-04-02",{"date":30,"type":31},"2024-04-03","ACTUAL",{"date":33,"type":31},"2023-03-02",{"date":35,"type":20},"2026-12-31",{"name":37,"class":38},"Won Seog Kim","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":39},"100456983","phase-1-azacitidine-chop-for-patients-with-nodal-t-cell-lymphoma-with-t-follicular-helper-phenotype-acantus-100456983","NCT05230680","Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)","Multicenter, Open Label, Phase I\u002FII of Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype","Inclusion Criteria:\n\n1. Treatment-naïve patients with newly diagnosed nodal T-cell lymphoma with T-follicular helper (TFH) phenotype as determined by the following 2016 WHO diagnostic criteria:\n\n   * Angioimmunoblastic T-cell lymphoma\n   * Follicular helper T-cell lymphoma\n   * Peripheral T-cell lymphoma with follicular helper T-cell type\n2. 20 to 85 years of age at diagnosis\n3. ECOG performance status 0-2\n4. Cardiac function suitable for chemotherapy: LVEF ≥45% on echocardiography or MUGA\n5. Appropriate renal function: Serum Cr ≤2.0mg\u002FdL or eGFR ≥ 30mL\u002Fmin according to the Cockroft-Gault formula\n6. Appropriate hepatic function: ALT ≤2.5x upper limit of normal (ULN) (or ≤5x ULN in the presence of liver involvement), total bilirubin ≤2x ULN (or ≤3x ULN in the presence of liver involvement)\n7. Appropriate hematologic findings: absolute neutrophil count (ANC) ≥1,500\u002FμL, platelets ≥100,000\u002FμL (or ANC ≥500\u002FμL and platelets ≥50,000\u002F μL in the presence of bone marrow involvement)\n8. Written informed consent to participate in the study\n9. Capable of following the study visit schedule and other requirements in the protocol\n10. For women of childbearing potential, a negative pregnancy test\n11. Women of childbearing potential must use an effective method of contraception (i.e., hormonal contraception, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study period and for 3 months afterward. Men are to use an effective method of contraception during the study period and for 3 months afterward.\n12. Life expectancy ≥90 days (3 months)\n13. Hepatitis B or C infection: Hepatitis B carriers and subjects with inactive hepatitis C infection (normal levels of aminotransferases) are eligible if they take prophylactic antiviral drugs\n\nExclusion Criteria:\n\n1. Other subtypes of non-Hodgkin's lymphoma\n2. History of chemotherapy for Hodgkin's or other non-Hodgkin's lymphoma in the last 5 years\n3. History of active cancer diagnosed within the last 3 years (with the exception of completely resected non-melanoma skin cancer, papillary thyroid cancer, carcinoma in situ of cervical cancer or breast cancer, and localized prostate cancer)\n4. Uncontrolled hepatitis B (with the exception of asymptomatic HBsAg-positive or anti-HBcAb-positive cases receiving antiviral prophylaxis such as entecavir or tenofovir)\n5. History of chronic hepatitis C (with the exception of HCV IgG positive with a negative HCV-RNA quantification)\n6. History of human immunodeficiency virus (HIV) infection\n7. Congestive heart failure (NYHA class ≥3)\n8. Acute coronary syndrome (new-onset unstable angina or myocardial infarction) or ventricular tachycardia within 6 months prior to study entry\n9. History of major neurological or psychiatric illness, including dementia or epilepsy\n10. Severe chronic obstructive pulmonary disease with hypoxemia\n11. Cerebrovascular disease within 3 months prior to study entry (including transient cerebral ischemia)\n12. Unresolved wounds, ulcers, or bone fractures\n13. Uncontrolled active infections (viral, bacterial, or fungal infections)\n14. Concurrent use of other experimental drugs under investigation\n15. Known hypersensitivity to the investigational drugs\n16. History of major surgery or serious trauma within 21 days prior to study treatment. Open biopsy within 7 days prior to study treatment\n17. Male subjects who had not undergone a vasectomy and have a partner who plans to become pregnant or are unable to use a medically acceptable method of contraception (partner's sterilization or intrauterine device placement, or barrier method combined with diaphragm or condom) during the subject's participation in the study\n18. Pregnant or breastfeeding women or women of childbearing potential and men who are not willing to use appropriate methods of contraception during the study\n19. Previously treated for T-cell lymphoma with immunotherapy or chemotherapy, except for short-term corticosteroids (for less than 8 days) prior to selection\n20. Prior radiotherapy, except for those localized to a single lymph node\n21. Central nervous system involvement\n22. Contraindication to any of the drugs included in the chemotherapy\n23. History of administration of doxorubicin at \\>200 mg\u002Fm²","20 Years","85 Years",{"count":50,"type":20},41,[52,23],"PHASE1","Induction treatment (every 3 weeks, total 6 cycles)\n\n* Azacitidine D-2, -1, 1 (level 1: 50mg\u002Fm2, level 2: 75mg\u002Fm2, level 3: 100mg\u002Fm2, level 4: 125mg\u002Fm2)\n* Cyclophosphamide 750mg\u002Fm2 d1\n* Doxorubicin 50 mg\u002Fm2 d1\n* Vincristine 1.4 mg\u002Fm2 (Max: 2 mg) d1\n* Prednisolone 100mg PO d1-5 Maintenance treatment (every 4 weeks, total 12 cycles)\n* Azacitidine 75mg\u002Fm2 d1-5",[55],"T Cell Lymphoma","2023-10-19",{"date":58,"type":31},"2023-10-23",{"date":60,"type":31},"2022-07-01",{"date":35,"type":20},{"name":37,"class":38},""]