[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"total-body-irradiation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:total-body-irradiation":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100647386","phase-2-chlorophyllin-for-reducing-oral-mucositis-in-total-body-irradiation-prior-to-transplant-100647386",false,"NCT07709195","Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant","Chlorophyllin as an Adjunct for Reducing Oral Mucositis in Myeloablative Total Body Irradiation","ChROMME-TBI","Inclusion Criteria\n\n* Patients ≥12 and ≤65 years of age\n* First allogeneic stem cell transplant\n* Total body irradiation dose (fractionated) ≥8 Gy\n\nExclusion Criteria\n\n* Known hypersensitivity or contraindications to sodium chlorophyllin (CHL)","ALL","12 Years","65 Years",{"count":21,"type":22},17,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this phase II, single-arm interventional clinical trial is to evaluate whether oral sodium copper chlorophyllin (CHL) can reduce the frequency and severity of oral mucositis in patients aged 12-65 years undergoing myeloablative total body irradiation (TBI) as part of conditioning before their first allogeneic Hematopoietic Stem Cell Transplantation (HSCT).\n\nThe main questions it aims to answer are:\n\nDoes oral chlorophyllin reduce the incidence of Grade III and IV oral mucositis by day +28 after HSCT? Does oral chlorophyllin reduce the duration of severe oral mucositis and the need for total parenteral nutrition (TPN), opioid analgesics, and other treatment-related toxicities, while maintaining acceptable safety?\n\nParticipants will:\n\nReceive oral sodium copper chlorophyllin 750 mg once daily (tablet or oral suspension) starting 48 hours before TBI conditioning and continuing until day +28 after HSCT.\n\nUndergo standard myeloablative TBI-based conditioning and allogeneic Hematopoietic Stem Cell Transplantation (HSCT) as part of routine clinical care.\n\nHave regular clinical assessments for oral mucositis, treatment-related toxicities, engraftment, and graft-versus-host disease (GVHD).\n\nProvide blood and saliva samples at predefined time points for cytokine and pharmacokinetic analyses.",[28,29,30,31],"Oral Mucositis","Total Body Irradiation","Hematological Malignancies","Hematopoietic Stem Cell Transplantation (HSCT)",[33,28,34,35,36,37,29],"Chlorophyllin","Allogeneic HSCT","Phase II Trial","Supportive Care","Acute Leukemia","RECRUITING","2026-07-23",{"date":41,"type":42},"2026-07-27","ACTUAL",{"date":44,"type":42},"2024-10-30",{"date":46,"type":22},"2027-03-05",{"name":48,"class":49},"Tata Memorial Centre","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":50},"100567843","phase-3-bucy-vs-tbicy-for-allo-hsct-in-t-all-patients-100567843","NCT06673459","BuCy Vs. TBICy for Allo-HSCT in T-ALL Patients","Busulfan Plus Cyclophosphamide Vs. Total Body Irradiation Plus Cyclophosphamide for Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Acute T Lymphoblastic Leukemia: a Randomized Controlled, Open-label, Multi-center Clinical Trial","Inclusion Criteria:\n\n1. T-ALL patients aged \\> 2 years and ≤55 years;\n2. For the first time accept allo-HSCT;\n3. With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3; 4. Signing an informed consent form, having the ability to comply with study and follow-up procedures.\n\nExclusion Criteria:\n\n1. With other malignancies;\n2. With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy;\n3. With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation;\n4. With severe organ dysfunction;\n5. In pregnancy or lactation period;\n6. With any conditions not suitable for the trial (investigators' decision).","2 Years","55 Years",{"count":61,"type":22},430,[63],"PHASE3","T-cell acute lymphoblastic leukemia (T-ALL), a hematological malignant neoplasm of immature T cells, accounting for a morbidity of 10-15% among pediatric and 20-25% among adult patients of ALL. Despite the application of improved intensive therapies, the overall survival (OS) of T-ALL patients is still unsatisfactory, with a 5-year OS rate of less than 60% in adults and 85% in children. Over the past few decades, allogeneic hematopoietic stem-cell transplantation (allo-HSCT) has emerged as a potential and the most likely curative treatment for patients with high-risk hematological malignant neoplasms, and it has been proven that allo-HSCT could hold the potential to improve the prognosis of T-ALL patients and may even cure T-ALL.\n\nThe two most common myeloablative conditioning regimens for T-ALL patients with allo-HSCT were total body irradiation (TBI) plus cyclophosphamide (TBI-Cy) and busulfan (Bu) plus cyclophosphamide (BuCy). The most common use conditioning regimen for ALL patients is the TBI-Cy conditioning regimen over other hematological malignancy patients because TBI possess potent and distinct anti-leukemic effects, particularly in organs not easily affected by systemic chemotherapy and intense immunosuppressive effects. However, TBI-based conditioning regimens may cause a high risk of cataracts, interstitial pneumonitis (IP), engraftment failure and even subsequent malignant neoplasms (SMNs). To avoid these disadvantages, intravenous Bu replaced TBI as a part of conditioning.\n\nExtensive studies have shown that allo-HSCT with conditioning regimens based on TBI could benefit survival compared with conditioning regimens based on chemotheraphy in treating ALL. We retrospectively analyzed post-10-year data from T-ALL patients from two transplant centers, and all the databases were used to eliminate confounding factors via PSM. We demonstrated that the TBI-Cy conditioning regimen had inferior efficacy to the BuCy conditioning regimen, especially for T-ALL patients who were children, refractory, had extramedullary disease before transplantation, had active disease or an MRD-positive status at allo-HSCT, or who received haplo-HSCT.",[66,67,29,68],"T-Cell Lymphocytic Leukemia","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Chemotherapy","NOT_YET_RECRUITING","2024-11-02",{"date":72,"type":42},"2024-11-05",{"date":74,"type":22},"2024-12-01",{"date":76,"type":22},"2029-11-30",{"name":78,"class":49},"The First Affiliated Hospital of Soochow University","Total-body Irradiation"]