[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The First Affiliated Hospital of Soochow University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":607},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,118,0,25,[9,54,89,112,135,155,179,204,225,250,272,296,317,338,359,382,408,433,453,478,499,518,538,561,585],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100652349","phase-2-sonrotoclax-glofitamab-gemcitabine-and-oxaliplatin-for-relapsed-or-refractory-large-b-cell-lymphoma-100652349",false,"NCT07774234","Sonrotoclax, Glofitamab, Gemcitabine, and Oxaliplatin for Relapsed or Refractory Large B-Cell Lymphoma","A Single-Center, Single-Arm, Open-Label, Phase II Clinical Trial of Sonrotoclax, Glofitamab, Gemcitabine and Oxaliplatin in Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. Histologically confirmed CD20-positive relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS); large B-cell lymphoma transformed from an indolent B-cell lymphoma; EBV-positive large B-cell lymphoma; high-grade B-cell lymphoma; and double-hit or triple-hit lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements.\n2. At least one prior line of systemic anti-lymphoma therapy. Prior treatment should generally have included an anti-CD20 monoclonal antibody and an anthracycline, unless there was a clear contraindication or the treatment was unavailable.\n3. Age 18 years or older.\n4. At least one evaluable or measurable target lesion, defined as a lymph node lesion with a longest diameter greater than 1.5 cm or an extranodal lesion with a longest diameter greater than 1.0 cm.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n6. Adequate organ function, including left ventricular ejection fraction (LVEF) of at least 50%; creatinine clearance of at least 50 mL\u002Fmin, although a minimum of 40 mL\u002Fmin may be acceptable if the investigator determines that treatment can be administered safely; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 3 × the upper limit of normal (ULN), or no greater than 5 × ULN in the presence of hepatic involvement; total bilirubin no greater than 1.5 × ULN, or no greater than 3 × ULN in participants with Gilbert syndrome or hepatobiliary involvement; and corrected electrolytes and tumor lysis syndrome-related laboratory parameters considered suitable for treatment.\n7. Adequate hematologic function, including absolute neutrophil count (ANC) of at least 1.0 × 10\\^9\u002FL, platelet count of at least 50 × 10\\^9\u002FL, and hemoglobin of at least 60 g\u002FL. Transfusion support to meet these criteria is permitted. Participants with cytopenias attributable to bone marrow involvement by lymphoma are exempt from these hematologic requirements.\n8. A negative pregnancy test for women of childbearing potential. Male and female participants must agree to use effective contraception during study treatment and for the protocol-specified period after the last dose of study treatment.\n9. Estimated life expectancy greater than 3 months.\n10. Ability and willingness to provide written informed consent and comply with the study protocol.\n\nExclusion Criteria:\n\n1. Previous central nervous system involvement by lymphoma, including involvement of the brain parenchyma, meninges, cerebrospinal fluid, spinal cord, or intraocular structures.\n2. Major surgery or serious trauma within 2 weeks before enrollment, or clinically significant treatment-related adverse effects that have not adequately recovered.\n3. History of cerebral infarction or intracranial hemorrhage within 3 months before enrollment.\n4. Prior treatment with glofitamab.\n5. Documented disease progression during or after prior treatment with a BCL-2 inhibitor when, in the investigator's judgment, the participant is unlikely to derive benefit from sonrotoclax.\n6. Severe hypersensitivity to glofitamab, obinutuzumab, gemcitabine, oxaliplatin, sonrotoclax, or any of their excipients.\n7. Active infection that, in the investigator's judgment, cannot be adequately controlled.\n8. Human immunodeficiency virus (HIV) infection or inadequately controlled active hepatitis B virus or hepatitis C virus infection.\n9. Failure to meet the required washout period from prior antitumor therapy, including chemotherapy, radiotherapy, or antibody-drug conjugate therapy within 2 weeks or within 5 half-lives; monoclonal antibody or bispecific antibody therapy within 4 weeks; CAR T-cell therapy within 30 days; or autologous stem cell transplantation within 3 months. Prior allogeneic stem cell transplantation or active graft-versus-host disease is also exclusionary.\n10. High and inadequately controlled risk of tumor lysis syndrome before enrollment.\n11. Severe cardiovascular or pulmonary disease, including New York Heart Association Class III-IV heart failure, myocardial infarction within 6 months, unstable arrhythmia or angina, severe chronic obstructive pulmonary disease, active pneumonia, requirement for long-term supplemental oxygen, or resting oxygen saturation of 90% or lower.\n12. Current malignancy or another malignancy diagnosed within 3 years before enrollment, except for cured low-risk malignancies.\n13. Use of systemic corticosteroids equivalent to prednisone greater than 20 mg\u002Fday within 2 weeks before enrollment when the dose cannot be reduced to an acceptable level.\n14. Active bleeding, coagulation disorder, or an unacceptable bleeding risk as determined by the investigator.\n15. Pregnancy or breastfeeding, or plans to become pregnant or father a child during the study period.\n16. Psychiatric illness, cognitive impairment, drug or alcohol dependence, or any other factor that may interfere with understanding the study, providing informed consent, or complying with study procedures and follow-up.\n17. Any other condition that, in the investigator's judgment, may compromise participant safety, interfere with study conduct, or confound interpretation of study data.","ALL","18 Years",{"count":20,"type":21},39,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This investigator-initiated, single-center, single-arm, open-label Phase II study will evaluate the efficacy and safety of sonrotoclax in combination with glofitamab, gemcitabine, and oxaliplatin in adults with relapsed or refractory large B-cell lymphoma. Participants will receive six 21-day cycles of glofitamab, gemcitabine, oxaliplatin, and sonrotoclax, followed by six 21-day cycles of glofitamab and sonrotoclax. The primary objective is to evaluate the complete response rate at the end of Cycle 6 according to the Lugano 2014 criteria. The study plans to enroll 39 participants.",[27,28],"Large B-Cell Lymphoma (LBCL)","High-grade B-cell Lymphoma",[30,31,32,33,34,35,36,37,38,39,40],"Relapsed Large B-Cell Lymphoma","Refractory Large B-Cell Lymphoma","Diffuse Large B-Cell Lymphoma","Transformed Large B-Cell Lymphoma","EBV-Positive Large B-Cell Lymphoma","High-Grade B-Cell Lymphoma","Double-Hit Lymphoma","Triple-Hit Lymphoma","BCL-2","Sonrotoclax","Glofitamab","NOT_YET_RECRUITING","2026-08-16",{"date":44,"type":45},"2026-08-19","ACTUAL",{"date":47,"type":21},"2026-08-20",{"date":49,"type":21},"2030-08-20",{"name":51,"class":52},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":55,"slug":56,"hasResults":12,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":53},"100651580","a-prospective-single-arm-study-of-vabu-conditioning-regimen-in-allo-hsct-for-low-performance-or-high-comorbidity-aml-patients-in-cr1-100651580","NCT07762508","A Study of VABu Conditioning Regimen in Allo-HSCT for AML Patients","A Single-Arm, Prospective Clinical Study of the Efficacy and Safety of VABu Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Non-High-Risk AML Patients in CR1 With Low Performance Status (ECOG ≥ 2) or High Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI ≥ 2)","VABu","Inclusion Criteria:\n\n1. Age 18 to 70 years.\n2. Diagnosis of acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL), with first complete remission (CR1) achieved after induction chemotherapy.\n3. Classified as non-high-risk per ELN 2022 risk stratification guidelines.\n4. ECOG performance status ≥ 2 (not due to leukemia) OR Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) ≥ 2.\n5. Willing to undergo allogeneic hematopoietic stem cell transplantation and has a suitable donor.\n6. Voluntarily signs informed consent form after full understanding of the study.\n\nExclusion Criteria:\n\n1. Allergy to any component of the study drugs.\n2. Psychiatric or psychological disorders that prevent cooperation with treatment.\n3. Uncontrolled systemic or local severe infection.\n4. Severe dysfunction of major organs (heart, lung, liver, kidney) that, in the investigator's opinion, makes the patient unsuitable for enrollment.\n5. Currently participating in or planning to participate in any other clinical study.\n6. Any other conditions that, in the investigator's opinion, make the patient unsuitable for enrollment.","70 Years",{"count":64,"type":21},42,[66],"NA","This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.",[69,70],"Leukemia, Myeloid, Acute(AML)","Hematopoietic Stem Cell Transplantation (HSCT)",[72,73,74,75,76,60,77,78,79,80,81,82],"Acute Myeloid Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation","Conditioning Regimen","Venetoclax","Azacitidine","Low Performance Status","High Comorbidity Index","Single-Arm Study","Prospective Study","AML","Allo-HSCT",{"date":44,"type":45},{"date":85,"type":21},"2026-08",{"date":87,"type":21},"2029-07",{"name":51,"class":52},{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":53},"100650978","safety-and-feasibility-of-fmt-for-immune-recovery-after-hsct-100650978","NCT07755319","Safety and Feasibility of FMT for Immune Recovery After HSCT","Safety and Feasibility of Selective Fecal Microbiota Transplantation (FMT) for Immune Reconstitution in Immunodeficient Patients After Hematopoietic Stem Cell Transplantation (HSCT)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Receiving first allogeneic hematopoietic stem cell transplantation (allo-HSCT) with myeloablative or reduced-intensity conditioning\n* Able to complete scheduled follow-up visits and sample collections\n* Willing and able to provide written informed consent\n\nFor Phase 2 (FMT intervention): participants must additionally meet all of the following criteria at 6 months post-transplant:\n\n* Serum IgA \\\u003C 0.07 g\u002FL with IgG and IgM not yet recovered to normal range\n* No active grade III-IV acute graft-versus-host disease (GVHD)\n* Off systemic antibiotics for at least 2 weeks\n* Willing to receive fecal microbiota transplantation (FMT) and sign dedicated informed consent for the intervention\n\nExclusion Criteria:\n\n* Early post-transplant death or loss to follow-up\n* Active grade III-IV acute GVHD (at time of screening)\n* Continuous use of high-dose immunosuppressants (prednisone-equivalent dose \\> 1 mg\u002Fkg\u002Fday)\n* Refusal to participate or inability to comply with study procedures\n\nFor Phase 2 (FMT intervention): participants meeting any of the following criteria will be excluded from the FMT phase:\n\n* Gastrointestinal obstruction, perforation, or severe intestinal dysfunction\n* Severe cardiac, hepatic, or renal insufficiency that would preclude safe FMT administration\n* Known allergy or hypersensitivity to any component of the FMT preparation",{"count":97,"type":21},86,[99,24],"PHASE1","Patients who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) often experience slow and incomplete recovery of their immune system, particularly the part responsible for producing antibodies (humoral immunity). This can lead to increased risk of infections and other complications. Previous studies suggest that the gut microbiome and its metabolites, such as short-chain fatty acids (propionate and butyrate), play a critical role in immune recovery.\n\nThis study has two phases. In the first phase, we will observe changes in immune function, lymphocyte subsets, and gut metabolites (propionate and butyrate) before and at 1, 3, and 6 months after transplantation in 50-80 patients. We will compare patients with severe immune deficiency to those with normal recovery to identify differences in gut bacteria and metabolites.\n\nIn the second phase, we will perform selective fecal microbiota transplantation (FMT) in 6 patients who still have severe humoral immunodeficiency at 6 months post-transplant. The FMT capsules will be specially selected from donors whose gut bacteria are rich in both propionate-producing and butyrate-producing strains. Patients will receive 20 capsules daily for 3 consecutive days (60 capsules total). We will evaluate the safety and feasibility of this approach, and observe whether fecal secretory immunoglobulin A (sIgA) shows signs of recovery at 3 months after FMT.\n\nThe study is expected to take approximately 2 years to complete. Findings may provide a new precision microbiome-based strategy to promote immune recovery after transplantation.",[102,103],"Humoral Immunodeficiency","Hematopoietic Stem Cell Transplantation","2026-08-08",{"date":106,"type":45},"2026-08-12",{"date":108,"type":21},"2026-08-01",{"date":110,"type":21},"2028-10-31",{"name":51,"class":52},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":53},"100644626","phase-2-va-consolidation-in-intermediate-risk-aml-100644626","NCT07672262","VA Consolidation in Intermediate-Risk AML","A Prospective, Randomized, Open-Label Study of Venetoclax Combined With Azacitidine for Consolidation Therapy in Adult Intermediate-Risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO 2022 classification criteria;\n* Age ≥ 18 years;\n* Classified as intermediate-risk based on European LeukemiaNet (ELN) 2022 prognostic risk stratification;\n* Achieved first complete remission (CR) or CR with incomplete hematologic recovery (CRi) after ≤ 2 cycles of Venetoclax + Azacitidine (VA) induction therapy;\n* Has a suitable donor and is planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n* ECOG performance status score 0 to 2\n* Adequate organ function: creatinine clearance ≥ 50 mL\u002Fmin; AST and ALT ≤ 3 × ULN; total bilirubin ≤ 2 × ULN; LVEF ≥ 50%; life expectancy \\> 8 weeks\n* Voluntarily signed informed consent form and able to comply with study requirements\n\nExclusion Criteria:\n\n* Clinically active cardiovascular disease (uncontrolled arrhythmia\u002Fhypertension, NYHA Class 3\u002F4 heart failure, myocardial infarction within 3 months)\n* Active central nervous system (CNS) leukemia or extramedullary infiltration\n* Other serious diseases limiting participation (e.g., severe infection, renal failure)\n* Known HIV infection or uncontrolled severe viral hepatitis\n* Pregnant or breastfeeding women\n* Inability to understand, comply with protocol, or sign informed consent\n* Any other conditions deemed unsuitable by the investigator",{"count":120,"type":21},226,[24],"This clinical trial aims to compare the efficacy and safety of venetoclax-based consolidation therapy versus conventional consolidation chemotherapy (intermediate\u002Fhigh-dose cytarabine) in newly diagnosed adult patients with intermediate-risk acute myeloid leukemia (AML). Participants must have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[72,124,125],"Intermediate Risk Acute Myeloid Leukemia","Consolidation Therapy","RECRUITING","2026-08-04",{"date":129,"type":45},"2026-08-06",{"date":131,"type":45},"2026-06-01",{"date":133,"type":21},"2030-06-01",{"name":51,"class":52},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":143,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":146,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":152,"leadSponsor":154,"locationsCount":53},"100644594","venetoclax-tdm-in-newly-diagnosed-aml-exposure-response-and-prognosis-100644594","NCT07670130","Venetoclax TDM in Newly Diagnosed AML: Exposure-Response and Prognosis","Exposure-Response and Prognostic Analysis of Venetoclax Therapeutic Drug Monitoring in Newly Diagnosed AML","ND-AML","Inclusion Criteria:\n\n1. Diagnosis: Newly diagnosed acute myeloid leukemia (AML) confirmed according to the WHO 2022 or International Consensus Classification (ICC) criteria, based on bone marrow morphology, flow cytometry, and molecular genetics. Acute promyelocytic leukemia (APL) is excluded.\n2. Treatment regimen: Planned or already initiated first-line therapy with venetoclax plus azacitidine (VEN-AZA), with dosing determined by the treating physician according to routine clinical practice (no protocol-mandated dose restrictions).\n3. Age: ≥ 16 years.\n4. Informed consent: Willingness and ability to provide written informed consent for participation in this observational study.\n5. Follow-up: Agreement to attend scheduled follow-up visits and to permit clinical data collection at the time points specified in the study protocol.\n\nExclusion Criteria:\n\n1. Prior AML therapy: Prior treatment for AML, with the exception of leukapheresis, hydroxyurea, low-dose cytarabine, or corticosteroids.\n2. Concurrent interventional trials: Current participation in any interventional clinical trial, including those involving investigational agents.\n3. Extremely short life expectancy: Judged by the investigator to be unable to complete at least one full cycle of therapy and the associated follow-up.","16 Years",{"count":145,"type":21},50,"OBSERVATIONAL","Venetoclax combined with azacitidine (VEN-AZA) is the current first-line standard of care for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy. Although this regimen substantially improves remission rates, marked inter-individual variability is observed in clinical practice-ranging from severe myelosuppression or tumor lysis syndrome in some patients to poor response or early relapse in others. Venetoclax is primarily metabolized by CYP3A4, and its systemic exposure is modulated by multiple factors, including hepatic and renal function, concomitant medications (particularly azole antifungals), and UGT1A1 polymorphisms, leading to a 50%-70% inter-individual variability in blood drug concentrations.\n\nDespite this variability, the current VEN-AZA regimen employs a fixed-dose strategy (400 mg\u002Fday) without incorporating therapeutic drug monitoring (TDM) to guide individual dosing. Critical knowledge gaps remain: (1) whether a clear exposure-response relationship exists between venetoclax exposure and composite remission rate (CR+CRi); (2) what blood concentration range optimizes efficacy while minimizing toxicity; (3) which covariates significantly influence venetoclax clearance; and (4) whether early concentration sampling can reliably predict subsequent exposure and clinical outcomes.\\*\n\nTo address these questions, investigators designed a prospective study enrolling newly diagnosed AML patients receiving VEN-AZA therapy. Investigators aim to systematically characterize the exposure-response relationship, establish an optimal therapeutic concentration window, identify key covariates contributing to inter-individual pharmacokinetic variability, and evaluate early-sampling prediction strategies. The findings are expected to provide direct evidence for TDM-guided individualized dosing and to support a paradigm shift from a \"fixed-dose\" to a \"concentration-guided\" approach in precision AML therapy.",[149],"Acute Myeloid Leukemia (AML)",{"date":129,"type":45},{"date":131,"type":45},{"date":153,"type":21},"2027-06-01",{"name":51,"class":52},{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":170,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":53},"100625680","phase-2-venetoclax-combined-with-azacitidine-for-consolidation-therapy-in-aml-100625680","NCT07425782","Venetoclax Combined With Azacitidine for Consolidation Therapy in AML","A Prospective, Randomized, Open-Label Study of Venetoclax Combined With Azacitidine for Consolidation Therapy in Adult Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Diagnosis of AML confirmed by bone marrow morphology, flow cytometry, and molecular genetics, meeting WHO 2022 classification criteria;\n* Age ≥ 18 years;\n* Classified as high-risk according to the European LeukemiaNet (ELN) prognostic risk stratification for AML, including AML with myelodysplasia-related changes (AML-MRC) and therapy-related acute myeloid leukemia (t-AML);\n* Achieved CR or CRi after ≤ 2 cycles of VA induction chemotherapy;\n* Availability of a suitable donor, with plans to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n* Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 2 times ULN; left ventricular ejection fraction (LVEF) ≥ 50% as shown by echocardiography (ECHO); expected survival \\> 8 weeks;\n* Voluntarily signed the informed consent form and can understand and comply with study requirements.\n\nExclusion Criteria:\n\n* Presence of clinically active cardiovascular disease, such as uncontrolled ventricular arrhythmia, uncontrolled hypertension, congestive heart failure, cardiac disease classified as Class 3 or 4 according to the New York Heart Association (NYHA) Functional Classification, or a history of myocardial infarction within 3 months prior to screening;\n* Active central nervous system leukemia (CNSL) or extramedullary infiltration of leukemia;\n* Other serious diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);\n* Known human immunodeficiency virus (HIV) infection or uncontrolled severe viral hepatitis;\n* Pregnant or breastfeeding women;\n* Inability to understand, comply with the study protocol, or sign the informed consent form;\n* Any other conditions deemed by the investigator as unsuitable for participation in this study.",{"count":163,"type":21},216,[24],"The goal of this clinical trial is to compare the efficacy and safety of a venetoclax-based consolidation therapy versus conventional consolidation chemotherapy in newly diagnosed adult patients with high-risk acute myeloid leukemia (AML) who have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned for transplantation.\n\nThe main questions it aims to answer are:\n\nDoes consolidation therapy with a venetoclax-containing regimen lead to superior clinical outcomes compared to conventional chemotherapy in this specific patient population? What is the comparative safety profile of the venetoclax-containing consolidation regimen versus conventional chemotherapy in these patients? Participants will be randomly assigned to receive either the venetoclax-based consolidation therapy or the conventional consolidation chemotherapy before undergoing transplantation.",[72,125,167,168,169],"Venentoclax","High Risk","Hematopoietic Stem Cell Transplant (HSCT)",[72,125,167,171,172],"Allogenice Hematopoietic Stem Cell Transplantation","High risk",{"date":129,"type":45},{"date":175,"type":45},"2026-02-01",{"date":177,"type":21},"2028-11-26",{"name":51,"class":52},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":53},"100647672","phase-4-a-single-center-prospective-single-arm-clinical-study-exploring-the-treatment-of-newly-diagnosed-multiple-myeloma-patients-with-t1114-suitable-for-transplantation-using-the-sonkrd-regimen-100647672","NCT07709884","A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnosed Multiple Myeloma Patients With t(11;14) Suitable for Transplantation Using the SonKRd Regimen","A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnosed Multiple Myeloma Patients With t(11;14) Suitable for Transplantation Using the SonKRd Regimen, Consisting of Sodium Oxychloride, Caffizyme, Lenalidomide and Dexamethasone","Inclusion Criteria:\n\n1. Diagnosed as active multiple myeloma according to the diagnostic criteria outlined in the \"Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2024 Revision)\";\n2. Aged 18 or above, male or female;\n3. Initial diagnosis of multiple myeloma;\n4. The FISH test confirmed by a third-party laboratory is positive for t(11;14) or the previous FISH test report is positive for t(11;14);\n5. ECOG score of 0-2;\n6. Possessing the following organ function conditions, defined as:\n\n   HGB\\> 80g\u002Fdl Platelets \\> 50×10\\^9\u002FL Neutrophil count \\> 1×10\\^9\u002FL Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 times ULN; Creatinine clearance rate ≥ 30 mL\u002Fmin Blood oxygen saturation is ≥90%;\n7. Expected survival period is greater than 6 months; The patient understands the purpose and procedures of this trial, voluntarily participates in it, and signs a written informed consent form.\n\nExclusion Criteria:\n\n1. Have received any experimental drug treatment within 2 weeks;\n2. Secondary plasma cell leukemia;\n3. Transmyocardial amyloidosis with heart failure and arrhythmia;\n4. Creatinine clearance rate \\\u003C 30 ml\u002Fmin;\n5. Simultaneous presence of other tumors or a history of tumor, or having undergone anti-tumor treatment (including major surgery) within the last 3 weeks, except for the following tumor diseases or those who have been tumor-free for ≥3 years to date: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM clinical stage T1a or T1b), or previously treated prostate cancer;\n6. Accompanied by mental illnesses requiring inpatient treatment in psychiatric hospitals or controlled institutions, as well as continuous and frequent outpatient treatment, or exhibiting a dependent cognitive state that cannot be controlled by caregivers (confirmed by a specialist physician);\n7. Accompanied by severe pulmonary infection, skin and soft tissue infection, or urinary tract infection;\n8. Patients experiencing unstable angina pectoris or myocardial infarction, heart failure NYHA class III or IV, uncontrolled severe coronary artery disease, uncontrolled severe ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or third-degree conduction block within 4 months prior to enrollment, except for those with a cardiac pacemaker;\n9. Poorly controlled hypertension or hyperglycemia within 14 days prior to enrollment;\n10. Severe, uncontrolled medical disorders or active infections that may impair the subject's ability to receive the treatment specified in the protocol, including but not limited to HIV antibody-positive, syphilis antibody-positive, uncontrolled diabetes, and patients undergoing hemodialysis or peritoneal dialysis;\n11. Subjects with uncontrolled active or chronic liver diseases and medical histories (including but not limited to viral hepatitis, cirrhosis, non-alcoholic steatohepatitis) or subjects with significant abnormalities in liver function, or other liver-related diseases that, in the investigator's judgment, may affect drug metabolism or subject safety;\n12. Women who are pregnant or breastfeeding\n13. Situations where researchers determine that the participant is not suitable for enrollment.",{"count":187,"type":21},20,[189],"PHASE4","The goal of this study is to evaluate treatment of newly diagnosed multiple myeloma patients with t(11;14) suitable for transplantation using the SonKRd regimen, consisting of Sodium Thiotepa, Caffizotide, Lenalidomide, and Dexamethasone. Main objectives is to evaluate the MRD negative rate in newly diagnosed multiple myeloma patients with t(11;14) who are eligible for transplantation, treated with the SOTOKLA combined with KRd regimen.\n\nAnd the secondary objective is to evaluate the ORR, CR rate, 1-year sustained MRD negative rate, 2-year PFS rate, and safety of the SOTOLA combined with KRd treatment regimen in newly diagnosed multiple myeloma patients with t(11;14) who are suitable for transplantation.",[192,193,194,195],"Newly Diagnosed Multiple Myeloma","T(11;14)","Sotoclax","Carfilzomib","2026-07-16",{"date":198,"type":45},"2026-07-17",{"date":200,"type":21},"2026-07-01",{"date":202,"type":21},"2028-12-31",{"name":51,"class":52},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":53},"100638003","phase-2-a-study-of-glofitamab-plus-gemox-compared-with-standard-of-care-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100638003","NCT07599423","A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","An Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Standard of Care in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Signed Informed Consent Form.\n* Age 18 years or older at the time of signing the Informed Consent Form.\n* Histologically proven diffuse large B-cell lymphoma (DLBCL), including transformation from follicular lymphoma.\n* Relapsed or refractory disease after first-line chemoimmunotherapy, defined as refractory disease (no complete remission to first-line therapy, progressive disease as best response, stable disease after 3-4 cycles, or partial response after 6-8 cycles\u002Fprogression within 12 months of first-line therapy) or relapsed disease (complete remission followed by biopsy-proven relapse within 12 months of first-line therapy).\n* No known history or suspicion of central nervous system (CNS) involvement by lymphoma.\n* Life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* At least one bi-dimensionally measurable nodal lesion (1.5 cm or larger) or extranodal lesion (1 cm or larger) as measured on a CT scan.\n* Negative HIV test at screening.\n* Adequate hematologic function defined as hemoglobin 9.0 g\u002FdL or higher without transfusion in the past 7 days, absolute neutrophil count 1.0 x 10\\^9\u002FL or higher, and platelet count 75 x 10\\^9\u002FL or higher.\n* Adequate organ function defined as estimated creatinine clearance 60 mL\u002Fmin or higher, ALT\u002FAST 2.5 times the upper limit of normal (ULN) or lower, and total bilirubin 1.5 mg\u002FdL or lower (or 3 x ULN or lower in subjects with Gilbert's syndrome).\n* Cardiac ejection fraction greater than 50%, no evidence of pericardial effusion, and no clinically significant electrocardiogram findings.\n* No clinically significant pleural effusion.\n* Baseline oxygen saturation greater than 92% on room air.\n* Able to understand and complete study-related questionnaires.\n* Agreement to remain abstinent or use adequate contraceptive methods for both female and male participants during the treatment period and for the protocol-specified duration after the final dose.\n\nExclusion Criteria:\n\n* Contraindication to glofitamab components or a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.\n* Not eligible for autologous stem cell transplantation (ASCT).\n* Prior solid organ transplantation.\n* History of Richter's transformation or of indolent disease to diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL).\n* Peripheral neuropathy assessed to be greater than Grade 1 at enrollment.\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.\n* Use of any investigational therapy for treating cancer within 28 days prior to Cycle 1, any monoclonal antibody within 3 months, or systemic immunotherapeutic agents within 4 weeks or five half-lives (whichever is shorter).\n* Prior radiotherapy to the mediastinal or pericardial region.\n* History of autologous or allogeneic stem cell transplant.\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better, except for alopecia and anorexia.\n* Administration of a live, attenuated vaccine within 4 weeks before the first study treatment administration.\n* Received more than one line of therapy for DLBCL.\n* Corticosteroid use greater than 50 mg\u002Fday of prednisone or equivalent for purposes other than lymphoma symptom control.\n* Recent major surgery within 4 weeks before the first study treatment.\n* History of other malignancy that could affect compliance or interpretation of results, with exceptions for adequately treated low-grade or in situ carcinomas and malignancies in remission for at least 2 years.\n* Significant cardiovascular disease, such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina.\n* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS lymphoma.\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Current or past history of Waldenstrom macroglobulinemia.\n* History or presence of a clinically significant abnormal ECG.\n* Known or suspected active infection, reactivation of a latent infection, or any major episode of infection requiring hospitalization or IV antibiotics within 4 weeks of dosing.\n* History of severe treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents.\n* History of autoimmune disease, with specific protocol-defined exceptions for well-controlled conditions.\n* Clinically significant liver disease, including active viral\u002Fother hepatitis or cirrhosis.\n* Abnormal coagulation laboratory values defined as INR or PT greater than 1.5 x ULN, or PTT\u002FaPTT greater than 1.5 x ULN.\n* Suspected active or latent tuberculosis.\n* Positive test results for chronic hepatitis B infection (HBsAg positive) or positive test results for hepatitis C with positive HCV RNA.\n* Diagnosis with SARS-CoV-2 infection within 30 days prior to first study treatment, or documented infection within 6 months with persistent respiratory symptoms.\n* History of progressive multifocal leukoencephalopathy (PML).\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.",{"count":212,"type":21},96,[24],"The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed\u002Frefractory diffuse large B-cell lymphoma (R\u002FR DLBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).",[216],"Diffuse Large B Cell Lymphoma (DLBCL)","2026-07-10",{"date":219,"type":45},"2026-07-13",{"date":221,"type":21},"2026-07-22",{"date":223,"type":21},"2030-12-31",{"name":51,"class":52},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":234,"studyType":146,"phases":4,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":247,"leadSponsor":249,"locationsCount":53},"100646819","cmv-cmi-in-cscmvi-after-hsct-100646819","NCT07688759","CMV-CMI in csCMVi After HSCT","Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)","Inclusion Criteria:\n\n1. ≥18 years old and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n2. First CMV reactivation after transplantation;\n3. Life expectancy of ≥8 weeks;\n4. The participant (or legally acceptable representative, if applicable) has provided written informed consent for the trial.\n\nExclusion Criteria:\n\n1. Recurrence of CMV infection;\n2. primary CMV infection in CMV-seronegative recipients (R-);\n3. Resistance to known anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, maribavir, etc.);\n4. Currently receiving CMV-CTL treatment or lymphocyte infusion.",{"count":233,"type":21},40,"12 Weeks","Cytomegalovirus (CMV) reactivation is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), and the reconstitution of CMV-specific cell-mediated immunity (CMV-CMI) plays a key role in viral control.\n\nThis prospective, exploratory study will enroll 40 adult CMV-seropositive patients who experience their first CMV reactivation after allo-HSCT. CMV-specific T cell levels (IFN-γ-producing T cells stimulated by IE-1 and pp65 antigens) will be measured using ELISPOT at four time points: at diagnosis of CMV viremia, 3 weeks after initiating preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation. Patients will be followed for 12 weeks after stopping treatment.\n\nThe primary objective is to describe the changes in CMV-specific T cell levels over the therapy. Secondary objectives are to explore the relationship between these levels and the occurrence of refractory CMV infection, recurrent CMV infection, and CMV disease. Findings may help identify patients at high risk of progressing to severe or persistent CMV infection at an early stage of preemptive therapy, enabling personalized intervention strategies.",[237,70,238],"Cytomegalovirus Infections","Immune Reconstitution",[240,103,241,242],"Cytomegalovirus","Virus-specific T cells","cell-mediated immunity","2026-07-03",{"date":245,"type":45},"2026-07-07",{"date":131,"type":45},{"date":248,"type":21},"2028-08-31",{"name":51,"class":52},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":146,"phases":4,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":53},"100644120","younger-vs-older-donors-in-allo-hsct-tte-100644120","NCT07666568","Younger vs. Older Donors in Allo-HSCT: TTE","Prognostic Comparison of Allogeneic Hematopoietic Stem Cell Transplantation Using Younger Versus Older Donors: A Target Trial Emulation Study","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of hematologic malignancy.\n* Underwent first allogeneic hematopoietic stem cell transplantation.\n* HLA matching level of 0.5 or higher.\n* Available donor age information.\n* Available clinical follow-up and outcome data.\n\nExclusion Criteria:\n\n* Previous autologous or allogeneic hematopoietic stem cell transplantation.\n* HLA matching level below 0.5.\n* Missing donor age information.\n* Missing key exposure-defining or outcome-defining data required for the analysis.",{"count":258,"type":21},5000,"Hematopoietic stem cell transplantation is an important therapeutic approach for hematologic malignancies, and the impact of donor age on transplant outcomes remains an active area of investigation. Older donors may be associated with impaired stem cell fitness, delayed immune reconstitution, and reduced T-cell function. However, randomized controlled trials directly comparing transplant outcomes by donor age are difficult to conduct because of ethical constraints, and previous retrospective studies have yielded inconsistent findings due to confounding bias and limited causal interpretability. Target trial emulation (TTE) is a methodological framework that uses observational data to emulate the design principles of a randomized trial, thereby reducing biases such as immortal time bias, time-varying confounding, and prevalent-user bias, and improving the validity of causal inference. Therefore, this study will use a large single-center retrospective clinical cohort to perform a TTE analysis, aiming to approximate the causal framework of an randomized trial and systematically evaluate the effect of donor age on clinical outcomes after allo-HSCT, thereby providing higher-quality evidence to optimize donor selection strategies.",[261,262,263],"A Target Trial Emulation Study","Donor Age","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","2026-06-22",{"date":266,"type":45},"2026-06-24",{"date":268,"type":21},"2026-07-15",{"date":270,"type":21},"2027-12-21",{"name":51,"class":52},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":295,"locationsCount":4},"100641474","endofaster-robot-for-gastroesophageal-submucosal-tumors-a-randomized-controlled-study-100641474","NCT07655674","Endofaster Robot for Gastroesophageal Submucosal Tumors: A Randomized Controlled Study","Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study","Inclusion Criteria:\n\n1. Aged 18 to 80 years old;\n2. Submucosal tumors originating from the muscularis propria of gastric fundus, highly suspected as gastrointestinal stromal tumor (GIST) confirmed by endoscopic ultrasonography (EUS) and contrast-enhanced computed tomography (CT);\n3. Tumor diameter ranging from 1.0 cm to 3.0 cm;\n4. No active ulcer or bleeding on the lesion surface before operation;\n5. American Society of Anesthesiologists (ASA) physical status class I-III;\n6. Voluntarily signed written informed consent.\n\nExclusion Criteria:\n\n1. Tumor adhesion to serosa with unclear interface shown on EUS;\n2. High-risk GIST or distant metastasis indicated by imaging or endoscopy;\n3. History of gastric surgery or radiotherapy;\n4. High bleeding risk including coagulation disorders and patients unable to discontinue anticoagulant medications;\n5. Pregnant or breastfeeding women;\n6. Failure to cooperate with follow-up.","80 Years",{"count":281,"type":21},110,[66],"In endoscopic treatment for gastric submucosal tumors arising from the muscularis propria, does robot-assisted surgery yield a higher serosa preservation rate, shorter operative time and lower complication rates than conventional endoscopic procedures?",[285],"Gastric Submucosal Tumors",[287,288],"gastric submucosal tumors","Robotic endoscope","2026-06-17",{"date":291,"type":45},"2026-06-18",{"date":200,"type":21},{"date":294,"type":21},"2028-06-30",{"name":51,"class":52},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":146,"phases":4,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":314,"leadSponsor":316,"locationsCount":53},"100644427","cousin-vs-sibling-donors-in-haplo-hsct-100644427","NCT07662382","Cousin vs. Sibling Donors in Haplo-HSCT","Comparison of Outcomes of Haploidentical Hematopoietic Stem Cell Transplantation From Cousin Donors Versus Sibling Donors in Patients With Hematological Malignancies: A Target Trial Emulation Study","Inclusion Criteria:\n\n* Adult patients diagnosed with hematological malignancies, including acute leukemia (AL), chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), and non-Hodgkin lymphoma (NHL)\n* Receipt of first haploidentical hematopoietic stem cell transplantation between 2017 and 2024\n* Documented exact date of transplantation available in medical charts\n* Verifiable donor kinship classified as either cousin or sibiling\n* Complete longitudinal follow-up data accessible for outcome assessment\n\nExclusion Criteria:\n\n* Prior receipt of any form of hematopoietic stem cell transplantation\n* An age difference of more than 18 years between the donor and recipient\n* Failure of successful infusion of donor-derived hematopoietic stem cells following conditioning regimen",{"count":304,"type":21},1000,"This observational study aims to emulate a hypothetical pragmatic, multicenter, non-blinded clinical trial enrolling adult patients undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT) with grafts derived from either cousin or sibiling donors.\n\nThe main research question is whether cousin donor-derived haplo-HSCT is associated with inferior clinical outcomes relative to sibling donor-derived haplo-HSCT.\n\nStudy participants consist of adult patients diagnosed with hematological malignancies who underwent cousin or sibiling haplo-HSCT between 2017 and 2024, and all eligible recipients will receive regular follow-up assessments.",[307,308,309],"Hematopoietic Malignancies","Haploidentical Hematopoietic Stem Cell Transplantation","Donor","2026-06-16",{"date":312,"type":45},"2026-06-23",{"date":108,"type":21},{"date":315,"type":21},"2027-10-31",{"name":51,"class":52},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":337},"100598669","early-phase-1-efficacy-safety-and-pharmacokinetics-of-thiscart19a-combined-with-olverembatinib-in-patients-with-newly-diagnosed-philadelphia-chromosome-positive-acute-lymphoblastic-leukemia-100598669","NCT07074496","Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.","An Open, Prospective, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic Anti CD19 CAR-T Combined With a Novel Third-generation TKI Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.","Inclusion Criteria:\n\n1. Male or non-pregnant, non-lactating female patients who are 18 years of age or older.\n2. Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy.\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.\n4. Organ function as indicated by the following laboratory indicators must be met:\n\n1\\. Alanine aminotransferase (ALT) ≤ 5×upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 5×ULN; 2. Total bilirubin\\\u003C2×ULN; 3. 24-hour calculated creatinine clearance\\>30 mL\u002Fmin; 4. SpO2≥92%; 5. Cardiac ejection fraction (EF)≥40%;\n\nExclusion Criteria:\n\n1. Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU\u002FmL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Subjects with HBV-DNA \\\u003C 2000 IU\u002FmL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) ;\n2. Uncontrolled active infection;\n3. Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS;\n4. Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \\> 140mmHg and\u002For diastolic blood pressure \\> 90mmHg);\n5. Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is \\>50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension;\n6. Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL;\n7. Patients who have any other malignant tumors that require treatment;\n8. Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol\u002FL);\n9. Patients who are pregnant, planning to become pregnant or breastfeeding;\n10. Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug;\n11. Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and\u002For fail to comply with all required study procedures;\n12. Patients who suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.",{"count":187,"type":21},[326],"EARLY_PHASE1","This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia.",[329],"Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","2026-06-15",{"date":289,"type":45},{"date":333,"type":45},"2024-01-01",{"date":335,"type":21},"2028-07-01",{"name":51,"class":52},2,{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":53},"100642308","phase-1-safety-and-efficacy-of-rn1201-injection-as-first-line-treatment-for-newly-diagnosed-multiple-myeloma-100642308","NCT07652138","Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma","An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Willingness to participate in the trial and provide written informed consent.\n\n   * 2\\. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria.\n   * 3\\. BCMA-positive multiple myeloma documented at screening or in prior medical records.\n   * 4\\. Aged 18 - 70 years, any gender.\n   * 5\\. Life expectancy of at least 12 weeks.\n   * 6\\. Serum total bilirubin \\\u003C twice the upper limit of normal (ULN); serum creatinine within normal range;\n   * 7\\. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C three times ULN.\n   * 8\\. ECOG performance status score of 0 - 2.\n   * 9\\. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion.\n   * 10\\. Ability to adhere to the study visit schedule and protocol requirements.\n\nExclusion Criteria:\n\n1. Patients with serious active infections.\n\n   * 2\\. Subjects with acquired or congenital immunodeficiency.\n   * 3\\. Subjects with Class III\u002FIV heart failure per NYHA criteria.\n   * 4\\. Subjects with epilepsy or other central nervous system diseases.\n   * 5\\. Subjects with a history of primary cancer, except:\n\n     1. Resected non-melanoma (e.g., basal cell carcinoma)\n     2. Cured carcinoma in situ (e.g., cervical, bladder, breast cancer)\n   * 6\\. Systemic high-dose steroid use within 2 weeks before treatment.\n   * 7\\. Pregnant, breastfeeding women, or those planning pregnancy in 6 months.\n   * 8\\. Participation in other clinical trials within one month.\n   * 9\\. Major surgery within 14 days before the first study drug dose.\n   * 10\\. Any condition the investigator deems may raise subject risks or affect trial results.",{"count":346,"type":21},18,[99],"This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA\u002FCD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed multiple myeloma. Patients will receive lymphodepletion followed by a single infusion of RN1201. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.",[350,351],"Multiple Myloma","Newly Diagnosed Multiple Myeloma (NDMM)","2026-06-11",{"date":310,"type":45},{"date":355,"type":45},"2025-07-30",{"date":357,"type":21},"2027-11-30",{"name":51,"class":52},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":143,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":53},"100598496","phase-1-rn1201-injection-in-the-treatment-of-antibody-mediated-diseases-100598496","NCT07072247","RN1201 Injection in the Treatment of Antibody-Mediated Diseases","An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection in the Treatment of Antibody-Mediated Diseases","Inclusion Criteria:\n\nInclusion: - specific for Refractory immune-mediated PTR:\n\n1. Aged 16-65 years\n2. Diagnosed with refractory immune-mediated PTR\n3. Resistant to at least 3 standard therapies\n4. Able to understand the study and consent\n5. Projected survival time exceeding three months\n6. Left Ventricular Ejection Fraction (LVEF) ≥0.5 (as measured by echocardiogram)\n7. Creatinine \\\u003C1.6 mg\u002FdL\n8. Aspartate Aminotransferase (AST) \\\u003C three times the upper limit of normal\n9. Total bilirubin \\\u003C2.0 mg\u002FdL\n10. Karnofsky Performance Status (KPS) score ≥60.\n\nInclusion: -specific for Relapsed or Refractory Immune Thrombocytopenia\n\n1. Written informed consent obtained;\n2. Male or female patients aged 18 years or older on the day of informed consent signing;\n3. Left Ventricular Ejection Fraction (LVEF) ≥50% with no pericardial effusion;\n4. As assessed by the investigator, systemic treatment drugs (excluding supportive and symptomatic treatment, and prednisone at a daily dose of ≤10 mg or equivalent) can be discontinued prior to lymphodepletion preconditioning.\n5. Historically diagnosed with primary immune thrombocytopenia (ITP) (based on the 2019 International Working Group for ITP and the American Society of Hematology (ASH));\n6. At least two consecutive blood routine examinations showing reduced platelet count, with no significant abnormalities in blood cell morphology on peripheral blood smear microscopy;\n7. At the screening visit, the subject has no splenomegaly;\n8. Bone marrow examination: the bone marrow cytology of ITP patients is characterized by increased or normal megakaryocytes with maturation disorders (investigators may assess whether to accept previous bone marrow examination reports, and if previous reports are used, they must be kept as copies in the study documents);\n9. The subject is a refractory ITP patient who has not responded to first-line treatment drugs, second-line thrombopoiesis-stimulating agents, and rituximab therapy, or who has undergone ineffective splenectomy or postoperative recurrence, and after re-evaluation of the diagnosis, is still confirmed to have ITP;\n10. Relapsed ITP is defined as a decrease in platelet count to below 30×10⁹\u002FL after an initial response to treatment, or to less than twice the baseline level, or the reappearance of bleeding symptoms.\n11. The subject has received at least four weeks of the most recent treatment (non-biological background therapy, antimalarial monotherapy, antimalarial combined with oral glucocorticoids (OCS) and\u002For immunosuppressants, or combined therapy with OCS and\u002For immunosuppressants).\n\nExclusion Criteria:\n\nExclusion: - specific for Refractory immune-mediated PTR:\n\n1. Uncontrolled active infection\n2. Active hepatitis B or C infection\n3. Patient has HIV or syphilis infection\n4. Patient is pregnant or breastfeeding\n5. Patient has a history of allogeneic hematopoietic stem cell transplantation (allo-HSCT)\n6. Conventional treatment for antibody-mediated disease is effective\n7. According to the New York Heart Association (NYHA) classification, patients with Class III\u002FIV cardiovascular dysfunction\n8. Other contraindications that make participation in this study unsuitable.\n\nExclusion: - specific for Relapsed or Refractory Immune Thrombocytopenia\n\n1. Patients with the following conditions at the screening visit: Neutrophil count \\\u003C1×10⁹\u002FL; serum creatinine \\>1.5× upper limit of normal (ULN); immunoglobulin G (IgG) \\\u003C5 g\u002FL.\n2. Subjects with Class III or IV heart failure according to the NYHA classification (see Appendix I)\n3. Subjects with a history of epilepsy or other central nervous system diseases\n4. Patients with active viral, bacterial or other infections requiring systemic treatment at the screening visit (including active or latent tuberculosis (TB) or SARS-CoV-2), or with a history of clinically significant recurrent infections (e.g., Bacillus infection);\n5. Herpes or varicella-zoster virus infection within 12 weeks prior to the screening visit (particularly shingles);\n6. Patients positive for HCV or HBsAg are excluded. HBcAb-positive patients are eligible only if HBsAg (regardless of anti-HBs status) and HBV DNA are negative;\n7. Known history of primary or secondary immunodeficiency, or positive test results for HIV (ELISA and Western blot) at the screening visit;\n8. Live vaccine or attenuated live vaccine administration within 4 weeks prior to the baseline visit;\n9. Breastfeeding or pregnancy at the screening visit or prior to medication administration (positive serum or urine - β-hCG pregnancy test);\n10. Females of childbearing potential and males whose partners are of childbearing potential must use medically approved contraception or abstain from sexual intercourse during the study treatment period and for at least 6 months after its completion. Females of childbearing potential must have a negative serum HCG test within 7 days before study enrollment and must not be breastfeeding;\n11. History of malignancy, except for cured non-melanoma skin cancer, carcinoma in situ (e.g., cervical, breast, bladder, or prostate cancer), and tumors in complete remission for at least 3 years without evidence of recurrence;\n12. Any severe and\u002For unstable pre-existing medical, psychiatric condition, or other disease that the investigator considers may interfere with the patient's efficacy, safety, informed consent, or compliance with the trial protocol;\n13. Known hypersensitivity, intolerance, or contraindication to RN1201 or any excipients in the study drugs (including Fludarabine, Cyclophosphamide, and Tocilizumab), or a history of severe allergic reactions;\n14. Participation in other investigational studies within 30 days prior to enrollment or within five half-lives of the study drug, whichever is longer.","65 Years",{"count":368,"type":21},9,[99],"This single-arm, open-label exploratory trial aims to evaluate the safety, feasibility, and preliminary efficacy of RN1201 Injection in patients with antibody-mediated diseases, including refractory immune-mediated platelet transfusion refractoriness (PTR) and relapsed or refractory immune thrombocytopenia (ITP). Patients will receive RN1201 cells infusion following lymphodepletion. The study will assess safety, response rates, B-cell depletion, and immune reconstitution. Exploratory analyses will examine in vivo persistence and activity of RN1201.",[372,373],"Refractory Immune-mediated Platelet Transfusion Refractoriness","Relapsed or Refractory Immune Thrombocytopenia","2026-06-10",{"date":376,"type":45},"2026-06-12",{"date":378,"type":45},"2025-07-07",{"date":380,"type":21},"2027-07-30",{"name":51,"class":52},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":389,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":53},"100642519","phase-2-trastuzumab-rezetecan-neoadjuvant-therapy-in-thp-insensitive-her2-positive-early-breast-cancer-100642519","NCT07647263","Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer","An Interventional, Multicenter Study of Trastuzumab Rezetecan as Neoadjuvant Therapy in Patients With THP-Insensitive HER2-Positive Early Breast Cancer","Inclusion Criteria:\n\n* 1.Age ≥18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and the patient must agree to use effective contraception during treatment.\n* 2.Pathologically confirmed invasive breast cancer, stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2-positive disease defined as: immunohistochemistry (IHC) 3+; or IHC 2+ with confirmed HER2 gene amplification by fluorescence in situ hybridization (FISH).\n* 3.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.\n* 4.No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.\n* 5.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* 6.Ability to understand and provide written informed consent.\n* 7.Adequate organ function as evidenced by the following laboratory values:\n* Hemoglobin ≥90 g\u002FL\n* White blood cell count ≥3.5×10⁹\u002FL\n* Platelet count ≥100×10⁹\u002FL\n* Neutrophil count ≥1.5×10⁹\u002FL\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3× upper limit of normal (ULN)\n* Total bilirubin ≤1.5×ULN\n* Serum creatinine ≤1.5×ULN\n* 8.No evidence of myocardial ischemia on electrocardiogram (ECG); New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥55% on echocardiogram; cardiac biomarkers (cardiac troponin I \\[cTnI\\] and B-type natriuretic peptide \\[BNP\\]) within normal limits.\n* 9.All required baseline laboratory and radiologic examinations completed prior to neoadjuvant therapy.\n* 10.No dysphagia.\n* 11.Availability of complete clinical data.\n\nExclusion Criteria:\n\n* 1.Male breast cancer or inflammatory breast cancer.\n* 2.Metastatic breast cancer (Stage IV).\n* 3.Presence of other concurrent malignancies or history of malignancy other than breast cancer within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* 4.Receipt of any other concurrent anti-cancer therapy or participation in another clinical trial.\n* 5.Presence of severe non-malignant disease that would compromise patient compliance or place the patient at unacceptable risk.\n* 6.Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipated need for major surgery during the study period.\n* 7.Receipt of radiotherapy, chemotherapy, molecular targeted therapy, endocrine therapy, or major breast surgery for breast cancer within 4 weeks prior to study treatment; current or prior use of HER2-targeted monoclonal antibodies, HER2-targeted antibody-drug conjugates (ADCs), or tyrosine kinase inhibitors (TKIs).\n* 8.History of hypersensitivity or contraindication to any component of the study drugs.\n* 9.Poorly controlled cardiac symptoms or diseases, including: New York Heart Association (NYHA) Class II or higher heart failure; unstable angina; myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n\nDementia, intellectual disability, or any psychiatric disorder that impairs the ability to understand the informed consent form.","FEMALE",{"count":391,"type":21},124,[24],"This study is a response-adapted, multicenter, interventional trial enrolling patients with HER2-positive early or locally advanced breast cancer. All enrolled patients will first receive 2 cycles of standard neoadjuvant THP regimen, consisting of a taxane, trastuzumab, and pertuzumab. After the initial 2-cycle treatment, tumor response will be evaluated by radiologic imaging and patient-derived organoid (PDO) drug sensitivity testing.\n\nPatients with an inadequate response to THP are defined as those with \\\u003C50% tumor size reduction on imaging, or failure to reach the PDO sensitivity threshold (\\\u003C80% tumor cell killing for HER2+\u002FHR- tumors; \\\u003C60% for HER2+\u002FHR+ tumors). These non-responders will switch to receive 4 cycles of trastuzumab rezetecan (SHR-A1811), a novel HER2-targeted antibody-drug conjugate (ADC). Patients with a favorable response (≥50% tumor reduction or meeting the PDO threshold) will continue with an additional 4 cycles of THP.\n\nThe primary objective is to evaluate the pathologic complete response (pCR) rate in THP non-responders after switching to trastuzumab rezetecan. Secondary objectives include objective response rate (ORR), event-free survival (EFS), overall survival (OS), 3-year invasive disease-free survival (iDFS), and safety profiles of both treatment strategies. Outcomes in patients who continue THP will be described for exploratory purposes.\n\nA total of 124 patients will be enrolled. This response-adapted, individualized strategy aims to provide an effective option for HER2-positive breast cancer patients with an inadequate early response to conventional THP neoadjuvant therapy.",[395],"HER2-positive Breast Cancer",[397,398,399,400],"Breast Cancer","HER2-positive","Neoadjuvant therapy","Trastuzumab rezetecan","2026-06-09",{"date":330,"type":45},{"date":404,"type":45},"2026-03-24",{"date":406,"type":21},"2031-12",{"name":51,"class":52},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":366,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":53},"100642605","phase-2-shr2554aza--overlapped-modified-bucy-for-high-riskrelapsed-leukemiamds-100642605","NCT07575412","SHR2554\u002FAZA + Overlapped Modified BUCY for High-risk\u002FRelapsed Leukemia\u002FMDS","A Prospective, Multicenter, Open-label, Randomized Controlled Trial of SHR2554 Plus Azacitidine in Overlapped Sequential Combination With Modified BUCY Conditioning Regimen in Patients With High-risk or Relapsed\u002FRefractory Acute Leukemia and Myelodysplastic Neoplasms Secondary IDs","Inclusion Criteria:\n\n1. Age 15-60 years, of either sex.\n2. Diagnosis of AML or ALL according to the WHO 2022 criteria, with an indication for allogeneic hematopoietic stem cell transplantation:\n\n   AML with high-risk genetics at diagnosis (risk stratification per ELN 2022) or relapsed\u002Frefractory AML (meeting any of the following: refractory-failure to achieve complete remission (CR) after two cycles of induction chemotherapy; relapse-reappearance of blasts in peripheral blood or bone marrow (≥5%) after first CR, or extramedullary relapse (EMR)).\n\n   High-risk B-ALL at diagnosis (risk stratification per ELN 2022) or pre-transplant MRD-positive B-ALL.\n\n   Confirmed T-ALL. History of central nervous system leukemia (CNSL) or pathologically confirmed extramedullary disease (EMD) during AML or ALL.\n\n   Myelodysplastic neoplasms (MDS): IPSS score intermediate-2 or high; IPSS-R score high or very high; IPSS-M score high or very high.\n3. Availability of an appropriate HLA-matched donor.4: ECOG performance status 0-2.5: Adequate major organ function, defined as: Left ventricular ejection fraction ≥50%. Pulmonary function: DLCO ≥50% of predicted value. Liver function: ALT\u002FAST ≤3×ULN, total bilirubin ≤2×ULN. Renal function: estimated creatinine clearance (CrCl) ≥60 mL\u002Fmin.6: Ability to understand the study and voluntary signed informed consent.\n\nExclusion Criteria:\n\n1: Acute promyelocytic leukemia (APL);2: Active central nervous system leukemia;3: Prior allogeneic hematopoietic stem cell transplantation;4: Prior treatment with any EZH2 inhibitor;5: Uncontrolled active infection as assessed by the investigator;6: Myocardial infarction or unstable angina within the previous 6 months;7: Known hypersensitivity to SHR2554, azacitidine, or any excipient of the mBuCy regimen;8: Pregnant or breastfeeding women;9: Any other medical condition that, in the investigator's judgment, would preclude study enrollment.",{"count":416,"type":21},180,[24],"This study was designed as a prospective, multicenter, open-label, randomized controlled trial. Eligible participants were patients aged 15-65 years with high risk or relapsed\u002Frefractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic neoplasms (MDS), diagnosed based on bone marrow morphology, immunophenotyping, genetic testing, and treatment response assessment. The experimental group received SHR2554 combined with azacitidine as an overlapped sequential combination with the mBuCy conditioning regimen, whereas the control group received the mBuCy conditioning regimen, both followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 1-year event-free survival (EFS). Secondary endpoints include 2-year overall survival, 2-year cumulative incidence of relapse, transplant-related mortality, incidence of acute\u002Fchronic GVHD, and safety profiles.",[72,420,421,422,423,424,425],"Acute Lymphoblastic Leukemia","MDS","Transplantation, Stem Cell","Conditioning Therapy","SHR2554","Azacytidine","2026-06-08",{"date":374,"type":45},{"date":429,"type":21},"2026-06",{"date":431,"type":21},"2030-06",{"name":51,"class":52},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":446,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":450,"leadSponsor":452,"locationsCount":53},"100643501","va-induction-and-bridging-transplantation-for-hypoplasticsecondary-aml-100643501","NCT07635485","VA Induction and Bridging Transplantation for Hypoplastic\u002FSecondary AML","A Multicenter, Single-arm Clinical Study of Venetoclax Combined With Azacitidine Induction and Bridging to Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Hypoplastic or Secondary Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Previously untreated acute myeloid leukemia (AML) diagnosed according to the 2022 ELN guidelines. Patients with isolated extramedullary disease (i.e., no evidence of AML in bone marrow or peripheral blood) are not eligible.\n3. Bone marrow biopsy demonstrating cellularity \\\u003C20% or concurrent myelofibrosis; Or a prior history of an antecedent hematologic disorder, radiotherapy\u002Fchemotherapy-related history, or presence of myelodysplasia-related changes (AML-MRC according to WHO-HEAM5).\n4. The patient is deemed suitable for allogeneic hematopoietic stem cell transplantation as assessed by the treating physician.\n5. Adequate organ function, defined as follows: a. Good liver function: serum total bilirubin ≤2.0 × upper limit of normal (ULN); if considered due to Gilbert's disease or leukemia, serum total bilirubin \\\u003C3.0 × ULN. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered due to leukemia. b. Good renal function: serum creatinine ≤2.0 × ULN or creatinine clearance \\>30 mL\u002Fmin calculated using the Cockcroft-Gault formula. c. No history of chronic lung disease and no dyspnea. Otherwise, documented diffusing capacity of the lung for carbon monoxide ≤40% (adjusted for hemoglobin if available) and forced expiratory volume in 1 second\u002Fforced vital capacity ≥50%.\n6. ECOG performance status score 0-2.\n7. Ability to understand and voluntarily sign informed consent.\n8. Women of childbearing potential must have a negative serum pregnancy test before initiation of study treatment.\n\nExclusion Criteria:\n\n1. Prior treatment for AML, except non-cytotoxic therapy given to stabilize disease.\n2. White blood cell count ≥10×10⁹\u002FL, or presence of proliferation-associated gene mutations such as FLT3.\n3. Favorable risk group according to the 2022 ELN prognostic stratification, e.g., t(8;21), inv(16)\u002Ft(16;16), NPM1 mutation, or CEBPA bZIP in-frame mutation.\n4. No suitable stem cell donor available.\n5. Acute promyelocytic leukemia (APL).\n6. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia.\n7. Life-threatening immediate complications of leukemia, such as uncontrolled bleeding, hypoxic pneumonia, sepsis, and\u002For disseminated intravascular coagulation (DIC). Expected survival \\\u003C12 weeks.\n8. Prior allogeneic hematopoietic stem cell transplantation for a hematologic disorder.\n9. Current use of strong CYP3A4 inducers or narrow-therapeutic-window CYP3A4 substrates; enrollment is allowed only if these drugs can be switched to alternatives ≥5 half-lives before the first dose of study treatment.\n10. Active, uncontrolled systemic fungal, bacterial, or viral infection despite appropriate antibiotic, antiviral, or other therapy.\n11. Known infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) that cannot be controlled by therapy.\n12. Another active malignancy, unless the patient has been disease-free for ≥5 years before initiation of study treatment. However, patients with the following history\u002Fconcurrent conditions or similar indolent cancers are eligible: Basal cell or squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Prostate cancer found incidentally on histology.\n13. Significant active cardiac disease within 6 months before initiation of study treatment, including New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction, unstable angina, and\u002For stroke.\n14. Uncontrolled hypertension (systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>100 mmHg).\n15. Dysphagia, short-bowel syndrome, gastroparesis, or other conditions that limit oral intake or gastrointestinal absorption.\n16. Known history of progressive multifocal leukoencephalopathy (PML).\n17. Known hypersensitivity to any component of venetoclax or azacitidine.\n18. Female patient who is pregnant or breastfeeding.\n19. Any other medical or psychological condition that, in the investigator's opinion, could interfere with the patient's ability to sign informed consent or participate in the study.",{"count":145,"type":21},[66],"The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine（VA) induction followed by bridging allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the treatment of hypoplastic and secondary acute myeloid leukemia (AML).",[444,445],"Hypoplastic Acute Myeloid Leukemia","Secondary AML (Adult)",[75,76,82],"2026-06-07",{"date":401,"type":45},{"date":131,"type":21},{"date":451,"type":21},"2029-08-31",{"name":51,"class":52},{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":366,"enrollmentInfo":461,"targetDuration":4,"studyType":22,"phases":462,"briefSummary":464,"conditions":465,"keywords":469,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":475,"leadSponsor":477,"locationsCount":4},"100643498","phase-3-acalabrutinib-maleate-and-bortezomib-for-patients-with-hla-antibodies-100643498","NCT07635511","Acalabrutinib Maleate and Bortezomib for Patients With HLA Antibodies","Acalabrutinib Maleate Monotherapy or in Combination With Bortezomib for Eliminating HLA Antibodies in Patients With Hematologic Malignancies and Platelet Transfusion Refractoriness: a Multicenter, Randomized Controlled Study","AB-HLA-2026","Inclusion Criteria:\n\n* Patients with hematological malignancies and platelet transfusion refractoriness (24-hour CCI \\\u003C 4.5×10⁹\u002FL or PPR \\\u003C 20%), and with the highest MFI of HLA antibodies \\> 8000 ;\n* Age 18-65 years, both male and female;\n* ECOG performance status 0-3;\n* Expected survival \\> 6 months;\n* Patients must be able to understand and be willing to participate in this study, and sign an informed consent form.\n\nExclusion Criteria:\n\n* Hypersensitivity to acalabrutinib, bortezomib, or excipients;\n* Major organ bleeding (central nervous system, lung, intestines) or grade ≥3 bleeding;\n* Hypersplenism;\n* Concurrent use of drugs that may cause excessive platelet consumption (amphotericin B, vancomycin, ATG, interferon, etc.);\n* Disseminated intravascular coagulation, microangiopathic hemolytic anemia;\n* Underlying diseases of vital organs: such as malignant arrhythmia, myocardial infarction, chronic cardiac insufficiency, decompensated liver insufficiency, renal insufficiency, severe coagulation abnormalities, etc.; persistent fever (\\>38.0°C) for more than 3 days; clinically uncontrolled active infection (including bacterial, fungal, or viral infections), but patients under effective drug therapy are not excluded;\n* Concurrent other progressive malignancies;\n* Patients with cardiac insufficiency: ejection fraction (EF) \\\u003C30%, NYHA class ≥III cardiac insufficiency;\n* Pregnant or lactating women;\n* Expected survival \\\u003C60 days;\n* Currently participating in other clinical drug trials.",{"count":64,"type":21},[463],"PHASE3","Platelet transfusion refractoriness (PTR) is a common complication in patients with hematological malignancies. It not only prolongs the duration of platelet transfusion dependence and significantly increases the risk of bleeding, but is also strongly associated with graft failure and reduced survival after transplantation. HLA class I antibody-mediated alloimmunization is recognized as the most important immunological cause of PTR. HLA antibodies are directly secreted by plasma cells, which are derived from B cells. Therefore, targeting B cells to reduce antibody production is a crucial step in eliminating HLA antibodies. Bruton's tyrosine kinase (BTK) is expressed throughout B cell development from the pre-B cell stage to maturity and supports B cell development, maturation, survival, proliferation, and antibody production by acting as a downstream kinase in the B cell receptor signaling pathway. Bortezomib, a proteasome inhibitor, can selectively induce apoptosis in long-lived plasma cells. The investigators' preliminary exploratory use of a BTK inhibitor in the treatment of PTR with HLA antibodies significantly reduced the mean fluorescence intensity (MFI) of HLA antibodies, improved platelet transfusion outcomes, and demonstrated a favorable safety profile. Based on these findings, the investigators are conducting a prospective, multicenter, randomized controlled two-arm study to investigate the efficacy and safety of acalabrutinib and bortezomib in eliminating HLA antibodies in hematological malignancies patients with PTR.",[466,467,468],"Hematological Malignancies","Platelet Transfusion Refractoriness (PTR)","HLA Antibodies",[470,471,472],"hematological malignancies","Platelet transfusion refractoriness","HLA antibodies",{"date":401,"type":45},{"date":131,"type":21},{"date":476,"type":21},"2029-05-31",{"name":51,"class":52},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":485,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":53},"100419707","efficacy-and-safety-of-auto-fmt-in-preventing-agvhd-100419707","NCT04745221","Efficacy and Safety of Auto-FMT in Preventing aGVHD","Efficacy and Safety of Autologous Fecal Bacteria Transplantation in Preventing Acute Graft Versus Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation: a Multicenter, Open, Randomized Controlled Clinical Study","Inclusion Criteria:\n\n* Haplo-HSCT patients; Bacteroidetes \\>0.1%; inverse Simpson diversity ≥2\n\nExclusion Criteria:\n\n* Gastrointestinal diseases；Age\\>60; or Age\\\u003C10；Probiotics or prebiotics were taken before enrollment","60 Years",{"count":487,"type":21},100,[66],"To evaluation the efficacy and safety of autologous fecal bacteria transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation. Bone marrow transplant patients were recruited.",[491],"Graft Versus Host Disease, Acute","2026-05-28",{"date":131,"type":45},{"date":495,"type":45},"2021-03-01",{"date":497,"type":21},"2027-03-01",{"name":51,"class":52},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":506,"sex":17,"minAge":507,"maxAge":485,"enrollmentInfo":508,"targetDuration":4,"studyType":146,"phases":4,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":53},"100297187","fmt-in-gut-agvhd-treated-100297187","NCT03148743","FMT in Gut aGVHD Treated","Department of Hematology of First Affiliated Hospital of Soochow University","Inclusion Criteria:\n\n* gut GVHD\n\nExclusion Criteria:\n\n* Age\\>60; or Age\\\u003C10",true,"10 Years",{"count":145,"type":21},"With the stem cell transplanting increasing, patients which effected with gut GVHD were also increased. To evaluation the safety and efficacy of FMT for gut GVHD,patients with gut GVHD were recruited.",[511],"Acute-graft-versus-host Disease",{"date":131,"type":45},{"date":514,"type":45},"2017-05-16",{"date":516,"type":21},"2029-12-01",{"name":51,"class":52},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":527,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":53},"100632264","phase-1-u96-car-t-cells-for-rr-b-all-100632264","NCT07511426","U96-CAR-T-Cells For R\u002FR B-ALL","A Single-arm, Open-label Clinical Study on the Safety and Preliminary Efficacy of in Vivo CAR-T (U96) in the Treatment of Relapsed\u002FRefractory B-cell Tumors","Inclusion Criteria:\n\n* (All the following items must be met simultaneously)\n\n  1. Patients must voluntarily sign the informed consent form and have good compliance;\n  2. For different indications, patients must meet the following requirements:\n\n     2-1) Patients in the acute B lymphoblastic leukemia group:\n     1. The age at signing the informed consent form is ≥ 18 years old, both male and female are acceptable;\n     2. According to the standards of the National Comprehensive Cancer Network (NCCN) Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2024, 2nd Edition), it is clearly diagnosed as acute B lymphoblastic leukemia;\n     3. According to the \"Chinese Adult Acute Lymphoblastic Leukemia Diagnosis and Treatment Guidelines\" (2021 Edition), one of the following conditions must be met: a. Refractory leukemia: standard induction therapy fails to achieve CR\u002FCRi after (generally referring to 4-week regimen or Hyper-CVAD regimen) completion; b. Leukemia recurrence: patients who have achieved CR have peripheral blood or bone marrow with blast cells (proportion \\> 5%) or MRD positive or extramedullary lesions; 2-2) Patients in the B-cell lymphoma group:\n\n     \u003C!-- -->\n\n     1. The age at signing the informed consent form is ≥ 18 years old, both male and female are acceptable;\n     2. According to the standards of the National Comprehensive Cancer Network (NCCN) B-cell lymphoma clinical practice guidelines (2024, 3rd Edition), it is clearly diagnosed as B-cell lymphoma;\n     3. Patients with B-cell lymphoma who have failed at least two-line treatment (one standardized chemotherapy regimen + one salvage chemotherapy) or have relapsed before screening. The previous treatment of B-cell lymphoma must include CD20 monoclonal antibody (excluding CD20-negative tumor patients) and anthracycline-based standardized treatment regimen. At least one of the following conditions must be met: a. Unable to undergo autologous hematopoietic stem cell transplantation; b. Refuse to undergo autologous hematopoietic stem cell transplantation; c. Relapse after autologous hematopoietic stem cell transplantation;\n     4. At screening, the patient is in a state of disease recurrence or refractory: a) Recurrence definition: after adequate treatment achieving remission (including partial remission (PR) or complete remission (CR)), PD again occurs; b) Refractoriness definition: i. No response to the last treatment: PD during\u002Fafter the last treatment or the best efficacy is SD, and the duration is less than 6 months; ii. Recurrence or progression after ASCT (requiring biopsy confirmation), including: recurrence or PD within 12 months after ASCT, if salvage treatment is received, no response (SD or PD) to the last treatment;\n  3. Bone marrow or peripheral blood or immunohistochemistry or pathology shows CD19 antigen positive;\n  4. According to the Lugano Lymphoma Response Evaluation Criteria (Cheson 2014), B-cell lymphoma patients have at least one evaluable lesion, or positive lesions confirmed by PET-CT;\n  5. Eastern Cooperative Oncology Group (ECOG) performance status score is 0-3;\n  6. At screening, there is a certain degree of bone marrow reserve, defined as: absolute lymphocyte value (ALC) ≥ 0.3×109\u002FL, platelet (PLT) ≥ 30×109\u002FL (allowing the result after administration);\n  7. Have appropriate organ function, and need to meet the following standards: aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≤ 3 times ULN (for liver function abnormalities caused by tumor infiltration, AST and ALT ≤ 5 times ULN are required); total serum bilirubin The serum bilirubin should be ≤ 2 times the ULN, except for those with Gilbert syndrome who have a combined condition; the total bilirubin should be ≤ 3 times the ULN and the direct bilirubin should be ≤ 1.5 times the ULN. Patients with Gilbert syndrome who meet these criteria can be included. The serum creatinine should be ≤ 1.5 times the ULN, or the creatinine clearance rate should be ≥ 60 mL\u002Fmin (Cockcroft and Gault formula); possess the lowest level of pulmonary reserve, defined as ≤ 1 grade of dyspnea and a blood oxygen saturation \\> 91% in non-oxygenated state; left ventricular ejection fraction of the left heart in echocardiography should be ≥ 50%; International Normalized Ratio (INR) should be ≤ 1.5 times the ULN, and activated partial thromboplastin time (APTT) should be ≤ 1.5 times the ULN;\n  8. The blood\u002Furine pregnancy test for women of childbearing age during the screening period should be negative. Any male or female patient with reproductive capacity must agree to use an effective contraceptive method throughout the study process and for at least 1 year after the administration of the study treatment;\n  9. The expected survival period should be greater than 3 months.\n\n     Exclusion Criteria:\n* (Any of the following conditions will disqualify one from participating)\n\n  1. Having another malignant tumor and the investigator considers that the presence of other malignant tumors may affect the current treatment;\n  2. Any of the following conditions: positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is greater than the minimum detection limit; positive for hepatitis C antibody (HCV-Ab), and the HCV-RNA copy number is greater than the minimum detection limit; positive for anti-mycoplasma antibody (TP-Ab); positive for human immunodeficiency virus (HIV) antibody;\n  3. Existing bacterial, fungal, viral, mycoplasma or other types of infections and the investigator determines that they are difficult to control;\n  4. Having a CNS disease other than this disease in the past or currently, such as epileptic seizures, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar disease or any CNS-related autoimmune disease, and the investigator determines that it is uncontrollable;\n  5. Before signing the informed consent form, having undergone cardiac angioplasty or stent placement within 12 months, or having NYHA classification III-IV grade congestive heart failure, or having myocardial infarction, unstable angina pectoris or the investigator determines that there is a clinically significant history of heart disease, or the patient's QTc interval is \\> 480 ms (QTc interval calculated using the Fridericia formula), and the left ventricular ejection fraction of the heart ultrasound is \\\u003C 50%;\n  6. Patients with primary immunodeficiency;\n  7. Having had a severe immediate-type hypersensitivity reaction to any drug used in this study;\n  8. Having received live vaccines within 6 weeks before screening;\n  9. Pregnant or lactating women;\n  10. Active autoimmune diseases;\n  11. Having active acute or chronic graft-versus-host disease (GVHD) at the time of signing the informed consent form, and the investigator determines that it is uncontrollable;\n  12. Participating in any other interventional clinical research within 30 days before signing the informed consent form;\n  13. Situations that the investigator deems unsuitable for participating in this study.",{"count":526,"type":21},30,[99],"This study is a single-arm, open-label clinical investigation to evaluate the tolerance, safety and preliminary efficacy of CAR-T (U96) in the treatment of relapsed\u002Frefractory B-cell tumors. The study will be conducted in two disease types, acute B-lymphoblastic leukemia and B-cell lymphoma, with a dose escalation plan using the \"3+3\" method. Each dose group is planned to enroll 3 to 6 patients, with a total of approximately 30 to 48 patients to be enrolled in the entire study. After signing the informed consent form, patients will undergo screening tests. If they meet the inclusion and exclusion criteria, they will be enrolled in the study. After receiving U96 treatment, patients will be followed up. It is recommended that they stay in the hospital for at least 14 days after administration. Safety and efficacy follow-ups will be conducted at 28 days and 3, 6, 12, 18, and 24 months after treatment. The follow-up period after treatment will last for 2 years, with a long-term follow-up of 15 years to assess the efficacy and safety until the end of the study or the patient withdraws from the study. For patients who have received U96 treatment, even if they withdraw from the study early, the investigators should still conduct long-term safety follow-ups according to the protocol to evaluate the long-term safety of the product.",[530],"Relapsed or Refractory B Cell Leukemia and Lymphoma","2026-05-26",{"date":492,"type":45},{"date":534,"type":21},"2026-07-30",{"date":536,"type":21},"2029-01-07",{"name":51,"class":52},{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":545,"targetDuration":546,"studyType":146,"phases":4,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":53},"100638914","pomalidomide-plus-anti-cd20-antibody-and-prednisone-in-frontline-indolent-b-cell-lymphoma-100638914","NCT07609446","Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma","Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma: A Prospective, Multicenter, Phase II Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of sex;\n2. Confirmed diagnosis of follicular lymphoma (FL), or histopathologically confirmed CD20-positive marginal zone lymphoma (MZL), including extranodal marginal zone lymphoma (MALT), splenic marginal zone lymphoma (SMZL), and nodal marginal zone lymphoma (NMZL),or confirmed diagnosis of indolent mantle cell lymphoma (MCL);\n3. Patients with a confirmed diagnosis of chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL);\n4. Confirmed diagnosis of lymphoplasmacytic lymphoma\u002FWaldenstrom macroglobulinemia;\n5. Presence of indications for treatment of indolent B-cell lymphoma;\n6. No prior systemic antitumor therapy for lymphoma;\n7. ECOG-PS score 0-2;\n8. Essentially normal bone marrow hematopoietic function, with routine blood tests as follows: white blood cell count \\>3000\u002FuL, absolute neutrophil count ≥1.5 × 10\\^9\u002FL (use of granulocyte colony-stimulating factor is allowed), platelet count ≥75 × 10\\^9\u002FL (transfusion to reach this minimum platelet count is allowed), and hemoglobin ≥9.0 g\u002FdL (prior red blood cell transfusion or use of recombinant human erythropoietin is allowed). If peripheral blood abnormalities are caused by lymphoma involvement of the bone marrow or spleen, neutrophils≥1.0 × 10\\^9\u002FL and platelets≥50 × 10\\^9\u002FL are acceptable (the investigator may determine at his\u002Fher discretion whether enrollment is appropriate);\n9. Normal function of major organs:\n\n   1. Hepatic function: serum bilirubin ≤2.0 × ULN; serum ALT and AST ≤2.5 × ULN;\n   2. Renal function: creatinine clearance \\>30 mL\u002Fmin;\n10. Expected survival≥3 months as judged by the investigator; Voluntary written informed consent signed before trial screening;\n\nExclusion Criteria:\n\n1. Current or prior other malignancy, unless curative treatment has been performed and there has been no evidence of recurrence or metastasis within the past 5 years;\n2. Lymphoma involvement of the central nervous system or transformation to a higher-grade lymphoma;\n3. Hepatic or renal dysfunction unrelated to lymphoma: alanine aminotransferase (ALT) \\>3 times the upper limit of normal, aspartate aminotransferase (AST) \\>3 times the upper limit of normal, total bilirubin (TBIL) \\>2 times the upper limit of normal, or serum creatinine \\>1.5 times the upper limit of normal;\n4. Other serious medical conditions that would affect this study (e.g., uncontrolled diabetes, gastric ulcer, or other serious cardiopulmonary diseases). The investigator has the authority to make this determination;\n5. Severe or uncontrolled infection;\n6. Clinically manifest central nervous system dysfunction;\n7. Major surgery within the past 30 days (excluding lymph node biopsy);\n8. Pregnant or lactating women, or women of childbearing potential who have not used contraceptive measures;\n9. Allergy to the study drug; Patients considered unsuitable for enrollment by the investigator.",{"count":526,"type":21},"12 Months","A Phase II Study of Pomalidomide Combined with Anti-CD20 Monoclonal Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma Objective: This prospective, single-arm, Phase II trial aims to evaluate the efficacy and safety of first-line pomalidomide plus anti-CD20 antibody and prednisone in patients with indolent B-cell lymphoma.\n\nStudy Population: Approximately 30 adult patients (age ≥18 years) will be enrolled. Eligible histologies include follicular lymphoma (FL), CD20-positive marginal zone lymphoma (MZL: extranodal MALT, splenic SMZL, nodal NMZL), indolent mantle cell lymphoma (MCL), chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL), and lymphoplasmacytic lymphoma\u002FWaldenström macroglobulinemia. Patients must be treatment-naïve, have an indication for systemic therapy, ECOG performance status 0-2, and adequate bone marrow reserve (ANC ≥1.5×10⁹\u002FL, platelets ≥75×10⁹\u002FL, hemoglobin ≥9.0 g\u002FdL; lower thresholds permitted if marrow\u002Fspleen involvement, per investigator discretion). Adequate organ function is required: bilirubin ≤2×ULN, ALT\u002FAST ≤2.5×ULN, and creatinine clearance \\>30 mL\u002Fmin. Life expectancy must be ≥3 months, and written informed consent is mandatory.\n\nExclusion Criteria: Patients are excluded if they have another malignancy within 5 years (unless curatively treated without recurrence), CNS lymphoma involvement, transformation to high-grade lymphoma, uncontrolled infection, severe comorbidities affecting study participation, significant non-lymphoma-related organ dysfunction (ALT\u002FAST \\>3×ULN, bilirubin \\>2×ULN, creatinine \\>1.5×ULN), active CNS dysfunction, major surgery within 30 days, pregnancy or lactation, lack of contraception in women of childbearing potential, known drug hypersensitivity, or any condition deemed unsuitable by the investigator.\n\nTreatment Regimen: Induction consists of six 28-day cycles. Anti-CD20 antibody is administered at 375 mg\u002Fm² weekly during Cycle 1 and on Day 1 of Cycles 2-6. Pomalidomide is given at 4 mg\u002Fday on Days 2-22 of Cycles 1-6. Prednisone is administered at 100 mg\u002Fday on Days 1-5 of Cycles 1-6. Maintenance therapy continues for 2 years with pomalidomide 4 mg\u002Fday on Days 1-14 and anti-CD20 antibody 375 mg\u002Fm² on Day 1 every 8 weeks.\n\nEndpoints: The primary endpoint is overall response rate (ORR). Secondary endpoints include complete response rate (CR), progression-free survival (PFS), overall survival (OS), and safety (hematologic and non-hematologic adverse events).\n\nStatistical Methods: Continuous variables will be summarized with descriptive statistics; categorical variables with frequencies and percentages. Time-to-event endpoints (PFS, OS, and duration of response) will be analyzed using the Kaplan-Meier method, reporting medians, quartiles, and 90% confidence intervals, along with event and censoring counts. ORR will be tested statistically and reported with a 90% confidence interval.\n\nTimeline: The study is expected to begin in January 2026, complete enrollment by December 2026, and conclude by December 2027. The total planned sample size is 30 patients.",[549,550,551,552],"Indolent Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Indolent Mantle Cell Lymphoma","2026-05-21",{"date":555,"type":45},"2026-05-27",{"date":557,"type":21},"2026-05-01",{"date":559,"type":21},"2027-12-31",{"name":51,"class":52},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":574,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":53},"100637785","romiplostim-for-oral-tpo-ra-resistant-itp-100637785","NCT07612319","Romiplostim for Oral TPO-RA Resistant ITP","A Prospective Cohort Study of Romiplostim in Immune Thrombocytopenia Patients Resistant to Oral Thrombopoietin Receptor Agonists","Inclusion Criteria:\n\nAge ≥18 years Diagnosed with primary immune thrombocytopenia (ITP) according to current guidelines\n\nFailed prior oral TPO-RA therapy (eltrombopag, hetrombopag, or avatrombopag), defined as:\n\nPlatelet count persistently \\\u003C30×10⁹\u002FL after ≥4 weeks of treatment at the maximum recommended or tolerated dose, OR Prior achieved response (platelet ≥50×10⁹\u002FL) then lost response with platelet count \\\u003C30×10⁹\u002FL on two consecutive visits (≥1 week apart), OR Intolerance to oral TPO-RA leading to discontinuation (with documented reason) Baseline platelet count \\\u003C30×10⁹\u002FL (at least two measurements, ≥5 days apart) ECOG performance status 0-2 Willing and able to receive weekly subcutaneous injections and comply with study procedures For women of childbearing potential: negative pregnancy test at screening and agreement to use effective contraception during the study and for 3 months after the last dose Able to provide written informed consent\n\nExclusion Criteria:\n\nSecondary ITP (e.g., associated with autoimmune diseases, lymphoproliferative disorders, drug-induced, or infections such as HIV\u002FHCV\u002FHBV) Known hypersensitivity to romiplostim or any of its excipients Prior treatment with romiplostim Received rituximab or other B-cell depleting therapy within 6 months prior to screening Received immunosuppressants (e.g., cyclosporine, mycophenolate mofetil, azathioprine, danazol) within 4 weeks prior to screening Splenectomy within 8 weeks prior to screening Use of corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or IVIG within 2 weeks prior to screening History of bone marrow fibrosis (MF grade ≥2) or known reticulin fibrosis History of arterial or venous thromboembolic event (e.g., myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening Known thrombophilic conditions (e.g., antiphospholipid syndrome, protein C\u002FS deficiency, ATIII deficiency) Severe hepatic impairment (ALT or AST \\>3×ULN, or total bilirubin \\>1.5×ULN) Severe renal impairment (creatinine clearance \\\u003C30 mL\u002Fmin) New York Heart Association (NYHA) functional class III or IV heart failure Malignancy within 5 years prior to screening (except non-melanoma skin cancer, cervical carcinoma in situ, or ductal carcinoma in situ of the breast) Pregnancy or breastfeeding Participation in another interventional clinical trial within 30 days prior to screening Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study",{"count":569,"type":21},60,[66],"This study is a prospective, multicenter, open-label, single-arm cohort study to evaluate the effectiveness and safety of romiplostim in patients with immune thrombocytopenia (ITP) who have not responded to oral thrombopoietin receptor agonists (TPO-RAs) such as eltrombopag, hetrombopag, or avatrombopag.\n\nITP is a blood disorder in which the immune system attacks and destroys the body's own platelets, leading to low platelet counts and an increased risk of bleeding. While oral TPO-RAs are effective for many patients, approximately 20-30% of patients do not respond adequately or lose response over time. For these patients, alternative treatments are urgently needed.\n\nParticipants in this study will discontinue their current oral TPO-RA and receive romiplostim as a weekly subcutaneous injection. The starting dose is 3 µg\u002Fkg, and the dose may be adjusted weekly based on platelet counts (maximum 10 µg\u002Fkg). The total treatment and follow-up period is 24 weeks.\n\nThe primary outcome measure is the durable platelet response rate at week 24, defined as maintaining platelet counts at ≥50×10⁹\u002FL for at least two scheduled visits during weeks 22-24 without rescue therapy. Secondary outcomes include the sustained response rate at week 12, complete response rate at week 24, time to first response, improvement in bleeding events, and quality of life assessment.\n\nSafety outcomes include monitoring for thromboembolic events, bone marrow fibrosis, hepatotoxicity, injection site reactions, and other adverse events according to CTCAE v5.0.\n\nApproximately 60 participants will be enrolled across multiple centers in China. This study aims to provide evidence for romiplostim as a treatment option for ITP patients who have failed oral TPO-RAs.",[573],"Immune (Idiopathic) Thrombocytopenic Purpura (ITP)",[575,576,577,578],"Immune Thrombocytopenia","Romiplostim","Thrombopoietin Receptor Agonists","Drug Resistance",{"date":492,"type":45},{"date":581,"type":45},"2026-03-15",{"date":583,"type":21},"2028-06",{"name":51,"class":52},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":485,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":594,"conditions":595,"keywords":597,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":53},"100640492","phase-2-vabu-conditioning-in-elderly-aml-hsct-100640492","NCT07583888","VABu Conditioning in Elderly AML HSCT","Efficacy and Safety of the VABu Conditioning Regimen in Elderly Patients With Acute Myeloid Leukemia Undergoing Hematopoietic Stem Cell Transplantation: An Open-Label, Multicenter, Single-Arm Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 60 years.\n2. Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis.\n3. Previous response to Venetoclax-based therapy.\n4. Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT).\n5. Donor availability: Related donor matched at least 5\u002F10 at HLA-A, -B, -C, -DQB1, and -DRB1; OR unrelated donor matched at least 8\u002F10 at the same loci.\n6. Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 4.\n7. ECOG performance status 0-2.\n8. Adequate organ function as defined by: Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 45 mL\u002Fmin (Cockcroft-Gault formula or 24-hour urine collection)； AST ≤ 3.0 × ULN and ALT ≤ 3.0 × ULN； Total bilirubin ≤ 1.5 × ULN； Left ventricular ejection fraction (LVEF) \\> 50%； Baseline oxygen saturation \\> 92%； DLCO ≥ 40% and FEV1 ≥ 50%；\n9. Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n1. Age \\\u003C 60 years.\n2. Poor response to prior Venetoclax-based therapy.\n3. Unstable systemic disease (unstable angina, myocardial infarction, cerebrovascular accident within 3 months; NYHA Class III-IV heart failure; severe arrhythmia; pulmonary hypertension).\n4. Active uncontrolled infection or active bleeding in vital organs.\n5. CNS symptoms grade ≥ 2 requiring treatment.\n6. Major organ surgery within 6 weeks.\n7. History of malignant disease other than AML within 5 years.\n8. History of thrombosis, embolism, or cerebral hemorrhage within 1 year.\n9. ECOG performance status \\> 2.\n10. HCT-CI score \\> 4.\n11. Organ failure meeting specified criteria.\n12. Known HIV, active HBV, or active HCV infection.\n13. History of autoimmune disease requiring systemic immunosuppressive therapy.\n14. Pregnancy, breastfeeding, or unwillingness to use effective contraception in patients of childbearing potential.\n15. Drug abuse or chronic alcoholism.\n16. Psychiatric disorder or other condition compromising informed consent or compliance.\n17. Any other condition making the patient unsuitable for study participation in the investigator's judgment.",{"count":187,"type":21},[24,463],"This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT).\n\nThe VABu regimen consists of Venetoclax, Azacitidine, Semustine, Cytarabine, and Busulfan. All enrolled participants will receive the VABu regimen as conditioning therapy prior to HSCT.\n\nThe study aims to enroll 20 participants from multiple centers in China. The primary objectives are to evaluate the overall response rate, cumulative relapse rate, overall survival, graft-versus-host disease (GVHD)-free relapse-free survival (GRFS), non-relapse mortality (NRM), incidence of acute and chronic GVHD, and reactivation rates of cytomegalovirus (CMV) and Epstein-Barr virus (EBV). Safety outcomes include treatment-related toxicities, such as bone marrow suppression, infection, and organ dysfunction.",[596,149],"Allogeneic Hematopoietic Stem Cell Transplantation Recipient",[598],"Acute Myeloid Leukemia; Elderly; Hematopoietic Stem Cell Transplantation; Venetoclax; Busulfan; Preconditioning","2026-05-12",{"date":601,"type":45},"2026-05-14",{"date":603,"type":21},"2026-05-07",{"date":605,"type":21},"2027-08-15",{"name":51,"class":52},""]