[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"St. Petersburg State Pavlov Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":266},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,73,106,137,163,192,210,237],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100578558","phase-2-pd-1-inhibitors-maintenance-for-chl-post-autohct-100578558",false,"NCT06812858","PD-1 Inhibitors Maintenance for cHL Post-autoHCT","A Multicenter Prospective Phase II Study Evaluating the Efficacy and Safety of PD-1 Inhibitors Maintenance in Patients With Refractory\u002FRelapsed Classical Hodgkin Lymphoma After Autologous Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* 18-70 years;\n* Diagnosis of r\u002Fr cHL with auto-HCT being performed as consolidation of 2 or later therapy lines;\n* High-risk cHL (Primary refractoriness after first-line therapy \u002F Relapse after first line therapy within 12 months \u002F PET\u002FCT-positive status at the time of auto-HCT \u002F Late relapse (\\> 12 months) with unfavourable prognosis factors (extranodal lesion and\u002For bulky and\u002For B-symptoms) \u002F More than one salvage regimen performed)\n* Complete or partial response by PET\u002FCT after auto-HSCT\n* No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study;\n* Achieved recovery of peripheral blood counts after auto-HSCT (white blood cell count\\> 1 109\u002FL, absolute neutrophil count\\> 0.5 109\u002FL, platelets \\> 25 109\u002FL);\n* ECOG 0-2; The decision to include patients that do not fulfil the criteria of hight-risk cHL is made in consultation with the PI\n\nExclusion Criteria:\n\n* Patients who have received PD1-inhibitor therapy in the previous lines of treatment and had to interrupt treatment early due to the development of adverse events of therapy;\n* Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN;\n* Respiratory failure of more than 1 degree at the time of inclusion in the study;\n* Unstable haemodynamics at the time of inclusion in the study;\n* Acute bacterial, viral or fungal infection at the time of inclusion;\n* Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and skin diseases such as vitiligo, allopecia, or psoriasis that do not require systemic therapy may be eligible);\n* Pregnancy or breastfeeding, or planning pregnancy or parenthood during the study period;\n* Somatic or psychiatric pathology that prevents the signing of informed consent;","ALL","18 Years","70 Years",{"count":20,"type":21},83,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R\u002FR) classical Hodgkin Lymphoma (cHL)",[27],"Hodgkin Lymphoma",[29,30,31,32],"Classic Hodgkin lymphoma","autologous hematopoietic stem cell transplantation","nivolumab","pembrolizumab","RECRUITING","2026-05-20",{"date":36,"type":37},"2026-05-22","ACTUAL",{"date":39,"type":37},"2024-01-09",{"date":41,"type":21},"2030-09",{"name":43,"class":44},"St. Petersburg State Pavlov Medical University","OTHER",4,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100610969","phase-2-comparison-of-avd--low-dose-nivolumab-vs-pet-adapted-beacopp-like-in-advanced-chl-100610969","NCT07234487","Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL","Randomized Study Comparing AVD Combined With Fixed-Dose Nivolumab Versus PET-Adapted BEACOPP-like Regimen as First-Line Treatment in Advanced Classical Hodgkin Lymphoma","Inclusion Criteria:\n\n* Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific therapy;\n* Patients with evidence of lesion extent assessed by whole-body PET\u002FCT;\n* Patients aged 18-60 years;\n* ECOG 0-2;\n* Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug;\n\nExclusion Criteria:\n\n* Severe organ failure: creatinine \\> 2 norms; alanine aminotransferase, aspartate aminotransferase \\> 5 norms; bilirubin\\> 1.5 norms;\n* Respiratory failure \\> grade 1 at the time of enrollment\n* Requirement for vasopressor support at the time of enrollment\n* Uncontrolled bacterial or fungal infection at the time of enrollment\n* Active or prior documented autoimmune disease requiring systemic treatment\n* Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period\n* Hypersensitivity or allergy to study drugs\n* Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent\n* Simultaneous use of drugs or medical devices studied in other clinical trials","60 Years",{"count":55,"type":21},178,[24],"Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens",[27],[27,60,61,62,63],"N-AVD","nuvolumab","BEACOPPesc","Low dose nivolumab","2026-03-31",{"date":66,"type":37},"2026-04-01",{"date":68,"type":37},"2024-10-14",{"date":70,"type":21},"2030-10",{"name":43,"class":44},3,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100611294","phase-2-optimization-of-post-transplantation-benadamustine-and-cyclophosphamide-in-patients-with-high-risk-myeloid-malignancies-and-a-partially-mismatched-donor-100611294","NCT07238712","Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor","Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor (APTBCy)","APTBCy","Inclusion Criteria:\n\n* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with \\\u003C10\u002F10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \\>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \\>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable\n\n\\- No severe concurrent illness\n\nExclusion Criteria:\n\n* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with \\\u003C10\u002F10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \\>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \\>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable\n\n\\- No severe concurrent illness",{"count":82,"type":21},60,[24],"Optimization of bendamustine-containg graft-versus-host disease (GVHD) prophylaxis to reduce the incidence of secondary haemophagocytic lymphohistiocytosis and GVHD",[86,87,88,89,90],"Acute Myeloid Leukemia (AML)","Chronic Myeloid Leukemia","Myelodysplastic Syndromes (MDS)","Myeloprolipherative Neoplsm","Atypical Chronic Myeloid Leukemia",[92,93,94,95,96],"Post-transplantation cyclophosphamide","Post-transplantation bendamustine","graft-versus-host disease","abatacept","ruxolitinib","2025-11-16",{"date":99,"type":37},"2025-11-20",{"date":101,"type":37},"2025-05-10",{"date":103,"type":21},"2026-12-10",{"name":43,"class":44},1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100598704","tonsillectomy-and-immunosuppression-in-caucasian-patients-with-high-risk-iga-nephropathy-100598704","NCT07074951","Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy","Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)","Inclusion Criteria:\n\nPrimary IgA-nephropathy (IgAN) patients with:\n\n1. DP \\>1 g with haematuria (\\>5 RBC\u002FHPF)\n2. DP \\\u003C1 g with haematuria AND probability of starting dialysis within 5 years \\>11% (estimated by the International risk-prediction tool in IgAN) AND at least one of the following histologic changes: at least one of the following histologic changes: mesangial proliferation, endocapillary hypercellularity, cellular crescents\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\>75 years;\n2. eGFR ≤20 ml\u002Fmin\u002F1.73m2\n3. Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP \\\u003C1.0 g\n4. Contraindications to IST or TE\n5. Patients with any co-existing kidney disease\n6. Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)\n7. Patients with diabetes mellitus\n8. Any clinically significant acute illness within 60 days prior to kidney biopsy (including infection, aseptic necrosis of any bone, patients with myocardial infarction or cerebrovascular stroke, other conditions that can be exacerbated by corticosteroids\n9. Incomplete empiric IST administered prior to kidney biopsy\n10. Pregnancy","75 Years",{"count":115,"type":21},240,[117],"NA","The open-label prospective non-randomised controlled aims to assess the efficacy of the combination of immunosupression (IST) and tonsillectomy (TE) in Caucasian patients at high risk of the IgA-nephropathy.",[120,121,122],"Primary IgA-nephropathy","High-risk","Caucasians",[120,124,125,121,122,126,127],"Corticosteroids","Tonsillectomy","Progression","Remission","2025-07-10",{"date":130,"type":37},"2025-07-20",{"date":132,"type":37},"2013-03-10",{"date":134,"type":21},"2027-12-10",{"name":43,"class":44},2,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":105},"100556974","phase-2-sorafenib-relapase-prophylaxis-after-hct-with-ptbcy-regimen-100556974","NCT06532084","Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen","Randomized Trial of Sorafenib Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplantation Bendamustine and Cyclophosphamide","SoraGVL","Inclusion Criteria:\n\n* Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.\n* Patients must have high-risk myeloid malignancy as an indication for transplantation defined as:\n\n  * acute myeloid leukemia not in hematological remission prior to transplantation,\n  * ≥ 3 remission of acute myeloid leukemia,\n  * any myeloid malignancy with bi-allelic tp53 mutation,\n  * any myeloid malignancy with complex karyotype,\n  * therapy-related myeloid malignancy not in MRD-negative response\n  * myelodysplastic syndrome with very high IPSS-R risk\n  * any myeloid malignancy with monosomal or t(3;3) karyotype,\n  * any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression\n  * MDS\u002FNPM unclassified not in hematologic remission.\n* Documented hematological remission in the bone marrow at the time of inclusion post-engraftment, measurable residual disease is allowed\n* First 100 days after allogeneic hematopoietic stem cell transplantation\n\nExclusion Criteria:\n\n* successfully treated relapse between transplantation and enrollment\n* use of any other planned method for prophylaxis of relapse besides sorafenib\n* donor lymphocyte infusion prior to randomization\n* Second malignancy not in complete remission within 6 months prior to randomization\n* Moderate or severe cardiac disease: ejection fraction \\\u003C50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3 months before inclusion\n* Stroke within 3 months of inclusion, unless related to the underlying malignancy\n* Severe decrease in pulmonary function: FEV1 \\\u003C50% or DLCO\\\u003C50% of predicted or respiratory distress or need for oxygen support;\n* Severe organ dysfunction: AST or ALT \\>10 upper normal limits, bilirubin \\>2 upper normal limits, creatinine \\>2 upper normal limits\n* Creatinine clearance \\\u003C 30 mL\u002Fmin\n* Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\\> 70 mg\u002FL\n* Requirement for vasopressor support at the time of enrollment\n* Requirement for positive-pressure oxygen at the time of enrollment\n* Karnofsky index \\\u003C30%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign informed consent",{"count":146,"type":21},88,[24],"This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.",[150,151,87,152],"Acute Myeloid Leukemia, in Relapse","Myelodysplastic Syndromes","Myeloproliferative Neoplasm",[154],"post-transplantation cyclophosphamide; post-transplantation bendamustine; acute myeloid leukemia; myelodysplastic syndrome; refractory; sorafenib","2024-07-29",{"date":157,"type":37},"2024-08-01",{"date":159,"type":37},"2024-05-22",{"date":161,"type":21},"2028-05",{"name":43,"class":44},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":181,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":105},"100555131","phase-2-vitamin-a-and-d-supplementation-in-allogeneic-hct-100555131","NCT06508099","Vitamin A and D Supplementation in Allogeneic HCT","Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation","VitaStem","Inclusion Criteria:\n\n* Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myeloproliferative disease, chronic myeloid leukemia, lymphoblastic lymphoma, myeloma\n* Standard disease risk: less than 5% clonal blasts in the bone marrow and the absence of blast forms in the peripheral blood at the time of inclusion in the study or at least partial response for lymphoproliferative neoplasms.\n* Related compatible donor 10\u002F10 HLA-matched or unrelated compatible donor 9-10\u002F10 HLA-matched\n* Age ≥18 years\n* Absence of severe concomitant somatic diseases\n\nExclusion Criteria:\n\n* \\- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 normal;\n* respiratory failure more than 1 degree. or oxygen dependence\n* Unstable hemodynamics;\n* Uncontrolled bacterial or fungal infection at the time of inclusion, despite adequate antibacterial or antifungal therapy (CRP\\>70 mg\u002Fl at the time of inclusion).\n* Karnofsky index less than 70%\n* Repeated allogeneic transplantation of hematopoietic cells;\n* Creatinine clearance below 60ml\u002Fmin\u002F1.73m2;\n* Severe cardiac pathology, including a decrease in ejection fraction less than \\\u003C50%, unstable angina, exertional angina of III-IV functional class, heart failure of III-IV functional class, arrhythmia grade V according to Lawn\n* Severe decrease in lung function, FEV1 \\\u003C50% or DLCO\\\u003C50% predicted\n* Pregnancy\n* Somatic or mental pathology that does not allow signing informed consent",{"count":172,"type":21},220,[24],"The therapy under investigation is the addition of 300 000 IU of vitamin A and 100 000 IU of vitamin D before conditioning. The study will include patients with malignant diseases in hematologic response with indications for allogeneic transplantation with matched related or matched unrelated donor.",[176,177,178,179,87,151,89,180],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Biphenotypic Acute Leukemia","Lymphoblastic Lymphoma","Non-hodgkin Lymphoma",[182,183,184],"allogeneic hematopoietic transplantation","vitamin A","vitamin D",{"date":186,"type":37},"2024-07-31",{"date":188,"type":37},"2024-05-15",{"date":190,"type":21},"2027-05",{"name":43,"class":44},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":209,"locationsCount":105},"100552781","phase-2-beflubu-vs-fluburux-conditioning-in-haploidentical-hct-100552781","NCT06477549","BeFluBu vs FluBuRux Conditioning in Haploidentical HCT","Randomized Trial of Benadamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation","Inclusion Criteria:\n\n* Patients must have an indication for allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease\n* Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, mixed lineage acute leukemia, lymphoblastic lymphoma, chronic myeloid leukemia, myelodysplastic syndromes, myeloprolipherative neoplasm\n* Age ≥18\n* Malignant disease in hematologic response: \\\u003C5% of clonal blasts in the bone marrow and no clonal blasts in peripheral blood.\n* Patients with 5-9\u002F10 HLA-matched related donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n\nExclusion Criteria:\n\n* Titer of anti-donor anti-HLA antibodies ≥ 5000 at the time of inclusion\n* Moderate or severe cardiac disease: ejection fraction \\\u003C50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3 months before inclusion\n* Stroke within 3 months of inclusion, unless related to the underlying malignancy\n* Severe decrease in pulmonary function: FEV1 \\\u003C50% or DLCO\\\u003C50% of predicted or respiratory distress or need for oxygen support;\n* Severe organ dysfunction: AST or ALT \\>5 upper normal limits, bilirubin \\>1.5 upper normal limits, creatinine \\>2 upper normal limits\n* Creatinine clearance \\\u003C 40 mL\u002Fmin\n* Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\\> 70 mg\u002FL\n* Requirement for vasopressor support at the time of enrollment\n* Karnofsky index \\\u003C70%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign informed consent",{"count":172,"type":21},[24],"Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning intensity and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 7-20% of graft failures in different diseases. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of diseases. In two previously completed trials of addition of either bendamustine and ruxolitinib to conditioning we observed low rates of primary graft failure with both approaches. The study is the direct randomized comparisons of these two approaches with the primary aim of reducing composite events of primary graft failure, relapse and non-relapse mortality. The stratas for the study are Disease Risk Index (DRI) and the age of the haploidentical donor (\\\u003C35 vs ≥35).",[176,177,178,179,152,151],"2024-06-21",{"date":205,"type":37},"2024-06-27",{"date":203,"type":37},{"date":208,"type":21},"2029-06",{"name":43,"class":44},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":105},"100503227","phase-1-ahsct-with-fludarabine-and-cyclophosphamide-based-conditioning-regimes-in-patients-with-multiple-sclerosis-100503227","NCT05832515","AHSCT With Fludarabine and Cyclophosphamide Based Conditioning Regimes in Patients With Multiple Sclerosis","Trial of the Efficacy and Safety of High-dose Immunosuppressive Therapy Based on Fludarabine and Cyclophosphamide-containing Conditioning Regimen Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Sclerosis.","Inclusion Criteria:\n\n* Age 18-65;\n* 1.0-6.5 points on the EDSS scale (for MS);\n* Length of illness - any;\n* Disease progression during the last 6 months while taking drugs of 1st and 2nd lines;\n* An established and confirmed diagnosis of an autoimmune disease in the previous stages of treatment;\n* Ineffectiveness, inaccessibility or intolerance of Disease-Modifying Therapies;\n* Relapse after AHSCT.\n* Absence of severe concomitant somatic pathology;\n* Left ventricular injection fraction \\> 50%;\n* Karnofsky Performance Score (KPS) \\> 30%;\n* The ability to take oral medications;\n* Life expectancy is more than 1 month;\n* Signed informed consent of the patient or legal representatives.\n\nExclusion Criteria:\n\n* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \\\u003C50%\n* Moderate or severe decrease in pulmonary function, FEV1 \\\u003C70% or DLCO\\\u003C70% of predicted\n* Respiratory distress \\>grade I\n* Severe organ dysfunction: AST or ALT \\>5 upper normal limits, bilirubin \\>1.5 upper normal limits, creatinine \\>2 upper normal limits\n* Creatinine clearance \\\u003C 60 mL\u002Fmin\n* Uncontrolled bacterial or fungal infection at the time of enrollment\n* Requirement for vasopressor support at the time of enrollment\n* Karnofsky performans status \\\u003C30%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign informed consent","65 Years",{"count":219,"type":21},200,[221],"PHASE1","One of the possible options for the treatment of MS at present is a high-dose immunosuppressive therapy followed by autologous hematopoietic stem cell transplantation (HIST-AHSCT), which is a highly effective treatment for patients with relapsing-remitting MS.\n\nThis method of MS treatment was introduced in 1997. Significant complications and mortality associated with HIST-ATHSC is an obstacle to broad use of this method. The risk is even greater in patients with advanced disease, long duration of previous treatment and aggressive forms of MS.\n\nDespite toxicity certain progressive cases of MS are still an indication for HIST-autoHSCT.\n\nMost commonly used conditioning regimens for multiple sclerosis include high-dose cyclophosphamide. One of the options to reduce cyclophosphamide-related toxicity and dose is addition of fludarabine. Fludarabine is a cytostatic drug, an antimetabolite from the group of purine antagonists. It has a pronounced immunosuppressive activity and no overlapping toxicity with cyclophosphamide. The study will evaluate the safety and efficacy of this combination.",[224],"Multiple Sclerosis",[226,227,228],"Autoimmune Diseases","AHSCT","Fludarabine","2024-05-06",{"date":231,"type":37},"2024-05-07",{"date":233,"type":37},"2020-10-01",{"date":235,"type":21},"2026-12-01",{"name":43,"class":44},{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":217,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":252,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":105},"100408242","oncological-benefits-of-pressured-intraperitoneal-aerosol-chemotherapy-pipac-in-patients-with-t3-4-gastric-cancer-cyt--100408242","NCT04595929","Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-","Single-center Randomized Study Evaluating of Oncological Benifits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Locally Advanced Gastric Cancer in Patients With Cyt-.","GASPACCO","Inclusion Criteria:\n\n* Histologically confirmed, medically operable, resectable stomach adenocarcinoma (cT3-4, any N category, M0).\n* No preceding cytotoxic or targeted therapy.\n* No prior partial or complete tumor resection.\n* Female and male patient ≥ 18 and ≤ 75 years. Female patient with childbearing potential needs to have a negative pregnancy test within 7 days prior to study start. Males and females of reproductive potential must agree to practice highly effective contraceptive measures\\* during the study. Male patients must also agree to refrain from father a child during treatment and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure.\n\n  \\*highly effective (i.e. failure rate of \\\u003C1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).\n* ECOG = 0-2.\n* Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI.\n* Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start of FLOT chemotherapy\n* Adequate hematological, hepatic and renal function parameters:\n\nLeukocytes ≥ 3000\u002Fmm³, platelets ≥ 100,000\u002Fmm³, neutrophil count (ANC) ≥1000\u002FµL Serum creatinine ≤ 1.5 x upper limit of normal Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN; for patients receiving therapeutic anticoagulation: stable anticoagulant regimen.\n\n* Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures.\n\nExclusion Criteria:\n\n* Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT.\n* Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel.\n* Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel.\n* Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV.\n* Clinically significant valvular defect.\n* Criteria of primary unresectability, e.g.:\n\nRadiologically documented evidence of major blood vessel invasion or invasion of adjacent organs (T4b).\n\nPatients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastases!).\n\n* Other severe internal disease or acute infection.\n* Peripheral polyneuropathy ≥ NCI Grade II.\n* Patient has undergone major surgery within 28 days prior to enrollment except staging laparoscopy.\n* Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites.\n* On-treatment participation in another interventional clinical study in the period 30 days prior to inclusion and during the study.\n* Patient pregnant or breast feeding, or planning to become pregnant.\n* Any other concurrent antineoplastic treatment including irradiation.",{"count":246,"type":21},304,[117],"Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.",[250,251],"Peritoneal Carcinomatosis","Gastric Cancer",[253,254,255,250,256,257],"Gastric cancer","Aerosol Chemotherapy","Regional Chemotherapy","Peritoneal washings","Intraperitoneal chemotherapy","2020-11-23",{"date":260,"type":37},"2020-11-25",{"date":262,"type":37},"2020-02-10",{"date":264,"type":21},"2029-01-10",{"name":43,"class":44},""]