[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xianmin Song, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"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":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100587570","phase-2-impact-of-low-intensity-chemotherapy-combined-with-short-course-blinatumomab-on-allo-hsct-in-adults-with-ph--b-all-100587570",false,"NCT06930105","Impact of Low-intensity Chemotherapy Combined With Short-course Blinatumomab on Allo-HSCT in Adults With Ph- B-ALL","Impact of Low-Intensity Chemotherapy Combined With Short-Course Blinatumomab on Allo-HSCT in Adults With Newly Diagnosed Ph-B-ALL: A Single-Arm, Prospective, Multicenter, Phase II Study","Inclusion Criteria:\n\nPatients (Age 18-60 years ) with an ECOG performance status of 0-2 and HCT-CI score \\\u003C3.\n\n2\\. Diagnosis: Confirmed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) by:\n\n* Bone marrow morphology\n* Cytochemistry\n* Immunophenotyping (CD19-positive by flow cytometry, ≥20% positivity on leukemic cells)\n* Chromosomal analysis\n* Molecular\u002Fgenetic testing. 3. Planned allo-HSCT candidates must have an eligible hematopoietic stem cell donor, including:\n* HLA-matched sibling donors\n* Unrelated donors (9\u002F10 or 10\u002F10 HLA allele-matched by high-resolution typing)\n* Haploidentical related donors. 4. No significant organ dysfunction:\n* Liver: ALT\u002FAST ≤3× upper limit of normal (ULN); total bilirubin ≤2× ULN.\n* Kidney: BUN and serum creatinine ≤1.25× ULN.\n* Cardiac:\n* No acute myocardial infarction or severe arrhythmia on ECG.\n* Left ventricular ejection fraction (LVEF) ≥50% on echocardiography; no significant cardiomegaly, valvular disease, or congenital heart defects.\n* Pulmonary: FEV1, FVC, and DLCO ≥60% of predicted values. 5. Contraception:\n* Men, women of childbearing potential (postmenopausal women must be amenorrheic for ≥12 months), and their partners must use investigator-approved effective contraception during treatment and for ≥12 months after the last study intervention.\n\n  6\\. Informed consent: Patients and their legal guardians must provide written informed consent, demonstrate willingness to undergo allo-HSCT, and agree to comply with treatment protocols, follow-up schedules, and laboratory tests.\n\nExclusion Criteria:\n\n1. Non-de novo patients(i.e., relapsed\u002Frefractory disease).\n2. BCR-ABL1 fusion gene-positive (Ph+ ALL confirmed by molecular testing).\n3. Uncontrolled active infections or viral diseases:\n\n   * Active bacterial, viral, or fungal infections requiring treatment.\n   * Hepatitis B: HBsAg-positive or HBcAb-positive with detectable HBV DNA in peripheral blood.\n   * Hepatitis C: HCV antibody-positive with detectable HCV RNA.\n   * Syphilis: Positive TRUST test.\n   * HIV: HIV antibody-positive.\n4. Major organ dysfunction or comorbidities:\n\n   * Cardiovascular:\n   * Uncontrolled hypertension, hypertensive crisis, or encephalopathy.\n   * History of congestive heart failure (CHF), unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia).\n   * Arterial thrombosis within 3 months (e.g., stroke, transient ischemic attack).\n   * Symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months.\n   * Coronary angioplasty, defibrillation, or other high-risk cardiovascular procedures.\n   * Pulmonary: Severe respiratory insufficiency.\n   * Gastrointestinal: Active bleeding within 3 months.\n5. Uncontrolled concurrent illnesses that may compromise safety or study integrity.\n6. Active or untreated central nervous system (CNS) involvement (e.g., CNS leukemia, epilepsy requiring therapy).\n7. Pregnancy, lactation, or plans for pregnancy within 1 year post-infusion or during the study period.\n8. Uncontrolled active infections (excluding uncomplicated UTIs or upper respiratory infections).\n9. Hypersensitivity to blinatumomab or its components.\n10. Inability to provide informed consent or comply with study procedures.\n11. Investigator discretion: Any condition deemed to jeopardize patient safety or interfere with study objectives.","ALL","18 Years","60 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This single-arm, prospective, multicenter, phase II study will enroll newly diagnosed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) patients aged 18-60 years. Participants will receive sequential low-intensity chemotherapy followed by a two-week blinatumomab induction therapy.\n\nTreatment Protocol\n\n1. Low-intensity chemotherapy (VIP regimen)\n\n   * V (Vincristine): 1.4 mg\u002Fm² (max 2 mg) on days 1 and 8.\n   * I (Idarubicin): 8 mg\u002Fm²\u002Fday on days 1 and 8.\n   * P (Prednisone): 60 mg\u002Fm²\u002Fday (max 100 mg\u002Fday) or equivalent dexamethasone dose on days 1-14.\n2. Sequential induction therapy:\n\n   * Blinatumomab administered for 2 weeks following the VIP regimen.\n3. Consolidation therapy for morphological complete remission (CR)\n\n   * Patients achieving CR receive two cycles of consolidation chemotherapy:\n   * Cycle 1: VDCP regimen (Vincristine, Daunorubicin, Cyclophosphamide, Prednisone).\n   * Cycle 2: VP + HD-MTX regimen (Vincristine, Prednisone + High-Dose Methotrexate).\n4. Allogeneic hematopoietic stem cell transplantation (allo-HSCT):\n\n   * Patients with multiparameter flow cytometry-confirmed minimal residual disease (MRD)-negative status proceed to allo-HSCT.\n\nPatients achieving morphological complete remission (CR) will undergo two cycles of consolidation chemotherapy. Those with minimal residual disease (MRD)-negative status confirmed by multiparameter flow cytometry (MFC) or next-generation sequencing (NGS) will proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 18-month relapse-free survival (RFS) rate, the secondary endpoints were composite response rate (CRc: CR + CR with incomplete hematologic recovery \\[CRi\\]), MRD-negative rate (assessed by MFC\u002FNGS),18-month overall survival (OS) post-transplant, non-relapse mortality (NRM), cumulative incidence of acute\u002Fchronic graft-versus-host disease (GVHD), cumulative relapse rate and 18-month GVHD-free\u002Frelapse-free survival (GRFS) post-transplant.",[27],"Acute Lymphoid Leukemia (ALL)","NOT_YET_RECRUITING","2025-08-05",{"date":31,"type":32},"2025-08-06","ACTUAL",{"date":34,"type":21},"2025-09-01",{"date":36,"type":21},"2028-05-01",{"name":38,"class":39},"Xianmin Song, MD","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100552067","phase-2-ric-with-thiotepa-combined-with-bufluara-c-in-allo-hsct-for-relapsed-or-refractory-ptcl-100552067","NCT06468267","RIC With Thiotepa Combined With Bu\u002FFlu\u002FAra-C in Allo-HSCT for Relapsed or Refractory PTCL.","Reduced Intensity Conditioning With Thiotepa Combined With Busulfan, Fludarabine and Cytarabine in Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma.","Inclusion Criteria:\n\n* Age between 18 and less than 70 years, regardless of gender\n* Peripheral T-cell lymphoma (PTCL) was diagnosed according to the 2016 WHO criteria and met any of the following criteria: Relapse: Except ALK+ anaplastic large cell lymphoma （ALCL), CR was achieved by standard chemotherapy but disease progressed，and relapse after hematopoietic stem cell transplantation;Refractory: Except ALK+ anaplastic large cell lymphoma （ALCL), the tumor shrank \\\u003C 50% or progressive disease after 4 courses of standard chemotherapy, or not achieve CR after 6 courses of standard chemotherapy;Not suitable for or refusing autologous hematopoietic stem cell transplantation.\n* Patients must have a suitable hematopoietic stem cell donor:Related donors must have at least 5\u002F10 matches for HLA-A, -B, -C, -DQB1, and - DRB1;Unrelated donors must have at least 8\u002F10 matches for HLA-A, -B, -C, -DQB1, and -DRB1\n* Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2\n* ECOG (Eastern Cooperative Oncology Group) performance status: 0-2\n* Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:Serum creatinine ≤ 1.5x ULN (the upper limit of normal);Cardiac function: Ejection fraction ≥ 50%;Baseline oxygen saturation \\> 92%;Total bilirubin ≤ 2.0 x ULN; ALT and AST ≤ 2.0 x ULN，AKP ≤ 2.0 x ULN;Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%\n* Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form\n\nExclusion Criteria:\n\n* PTCL patients did not meet the criteria of relapse \u002F refractory.\n* Refuse to adopt allegeneic hematopoietic stem cell transplantation.\n* History of malignancies other than lymphoid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer, basal cell carcinoma, squamous cell carcinoma of the skin, and curatively treated localized prostate cancer or ductal carcinoma in situ\n* ECOG ≥ 3.\n* HCT-CI score ≥ 3.\n* Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within the 3 months prior to screening, myocardial infarction within the 3 months prior to screening, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ III), severe arrhythmias requiring drug treatment after pacemaker implantation, significant liver, kidney, or metabolic diseases, and pulmonary arterial hypertension.\n* Active, uncontrolled infections, including those associated with hemodynamic instability, new or worsening infection symptoms or signs, new infectious lesions on imaging, or persistent unexplained fever without signs or symptoms of infection.\n* HIV-infected individuals.\n* Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy.\n* History of autoimmune diseases\n* Pregnant or breastfeeding women.\n* Fertile males and females unwilling to use contraception during the treatment period and for 12 months after treatment.","70 Years",{"count":49,"type":21},50,[24],"This study is a single-center, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an reduced-intensity conditioning (RIC) regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of relapse and refratory peripheral T-cells lymphoma. The conditioning regimen includes thiotepa at a dose of 5mg\u002Fkg\u002Fd at d -7 (1 day), fludarabine at 30mg\u002Fm2\u002Fd from d -6 to d -2 (5 days), cytarabine at 1g\u002Fm2\u002Fd from d -6 to d -2 (5 days), and busulfan at 3.2mg\u002Fkg\u002Fd from d -4 to d -3 (2 days). Conditioning begins on day -7, and donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. FDG-PET\u002FCT imaging will be adopted every 6 months after transplantation. If disease relapse is suspected during the follow-up period, bone marrow and relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.",[53],"Peripheral T Cell Lymphoma",[55,56,57],"peripheral T cell lymphoma","reduced intensity conditioning regimen","thiotepa","RECRUITING","2024-07-31",{"date":61,"type":32},"2024-08-01",{"date":63,"type":32},"2024-07-15",{"date":65,"type":21},"2026-07-15",{"name":38,"class":39},1,""]