[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hsct\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hsct":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,41,74,102,124,146,166,184,213,238,262,282,302,332,359,381],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100642410","hbv-reactivation-prediction-model-in-allo-hsct-100642410",false,"NCT07644026","HBV Reactivation Prediction Model in Allo-HSCT","Development and External Validation of a Nomogram for Predicting Hepatitis B Virus Reactivation in HBsAg-Negative\u002FAnti-HBc-Positive Patients Undergoing Allogeneic Haematopoietic Stem Cell Transplantation: A Multicentre Prospective Study","HBV-post HSCT","Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be enrolled in the study:\n\nPlanned allogeneic HSCT: Scheduled to undergo first allogeneic hematopoietic stem cell transplantation (allo-HSCT) for any hematologic malignancy or non-malignant hematologic disorder. Any donor type is permitted.\n\nResolved HBV infection: Documentation of both of the following serological markers on a blood sample collected within 30 days prior to the start of conditioning:\n\nHepatitis B surface antigen (HBsAg): negative Antibody to hepatitis B core antigen (anti-HBc): positive Note: Patients may be either positive or negative for anti-HBs at baseline. Willingness to follow protocol-defined monitoring: Patients (or legally authorized representatives) must agree to adhere to the study-specific HBV monitoring schedule as outlined in the protocol.\n\nInformed consent: Written informed consent obtained from the patient or a legally authorized representative prior to any study-related procedures.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded from the study:\n\nCo-infection with other hepatotropic viruses:\n\nPositive serology for hepatitis C virus (HCV) (anti-HCV antibody positive with detectable HCV RNA) Positive serology for hepatitis D virus (HDV) (anti-HDV antibody positive) Positive serology for human immunodeficiency virus (HIV)\n\nPre-existing advanced liver disease:\n\nClinical or histological evidence of liver cirrhosis (METAVIR stage F4, or imaging showing nodular liver surface\u002Fsplenomegaly\u002Fvarices) History of hepatic encephalopathy or variceal bleeding History of hepatocellular carcinoma (HCC) Prior solid organ transplantation (including kidney, liver, heart, or lung transplantation).\n\nPrevious allogeneic HSCT (patients receiving a second or subsequent allo-HSCT are excluded; prior autologous HSCT is allowed).\n\nActive uncontrolled infection at the time of enrollment that, in the opinion of the treating physician, would preclude safe participation.\n\nPregnancy or lactation at the time of enrollment. Female patients of childbearing potential must have a negative pregnancy test within 7 days before starting conditioning.\n\nLife expectancy \\\u003C6 months due to underlying disease or comorbid conditions, as judged by the treating physician.\n\nInability to comply with follow-up due to geographic, psychiatric, or social reasons.\n\nEnrollment in another interventional trial that prohibits co-enrollment in observational studies (at the discretion of the principal investigator).","ALL",{"count":19,"type":20},300,"ESTIMATED","3 Years","OBSERVATIONAL","Hepatitis B virus (HBV) reactivation is a serious complication after allogeneic haematopoietic stem cell transplantation (allo-HSCT), particularly in patients with resolved HBV infection (HBsAg-negative, anti-HBc-positive). The incidence ranges from 10% to 40%, and severe reactivation can lead to hepatitis flare, hepatic failure, and death.\n\nSeveral risk factors have been identified: low recipient anti-HBs titre, donor anti-HBs negativity, recipient age ≥50 years, chronic GVHD, and use of rituximab. However, no validated clinical prediction model exists for this specific population. The only available study (Zhang et al., BBMT 2020) performed risk factor analysis but did not develop a predictive nomogram, and the sample size was limited (only 16 reactivation events). Therefore, we aim to develop and externally validate a robust nomogram using a large multicentre retrospective cohort and then validate its performance in a prospective cohort",[25,26],"HBV Reactivation","HSCT",[25,26,28],"A Multicentre Prospective Observational Study","NOT_YET_RECRUITING","2026-06-08",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":20},"2026-06-20",{"date":37,"type":20},"2029-06-30",{"name":39,"class":40},"Xiao Hui Zhang","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100607812","phase-3-reduced-post-transplant-cyclophosphamide-dose-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplantation-for-hematological-malignancies-100607812","NCT07193420","Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies","Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies: a Phase III Randomized Study","REDUCy","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed hematological malignancy with an indication for allogeneic HSCT\n* Presence of a haploidentical donor willing to donate PBSC\n* Patient planned to receive a thiotepa-based conditioning regimen\n* Provision of written informed consent Affiliation to a social security system (excluding \"Aide Médicale d'État\")\n\nExclusion Criteria:\n\n* Karnofsky performance status \\\u003C 70%\n* Life expectancy \\\u003C 1 month, as determined by the attending physician\n* Acute or chronic heart failure, defined as left ventricular ejection fraction \\\u003C 40%\n* Pulmonary dysfunction with diffusion capacity \\\u003C 50% of predicted values\n* Renal impairment with estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin (calculated using the CKD-EPI formula)\n* Decompensated hemolytic anemia\n* Fanconi anemia and other DNA breakage repair disorders\n* Acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy\n* Obstruction of urinary outflow\n* Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines\n* Combination with products containing Hypericum perforatum\n* Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein (P-gp) or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and\u002For life-threatening events, e.g., bosentan, dabigatran etexilate and aliskiren\n* Active non-controlled infectious disease\n* Positive HIV status\n* Pregnancy, breast-feeding, or refusal to use effective contraception for the duration of the study and 6 months after the last treatment dose\n* Individuals under legal protection measures or unable to provide consent (e.g., severe neurological or psychiatric disorders, or deprivation of liberty by judicial or administrative decision)\n* Hypersensitivity to the active substance or any of the excipients\n* Concurrent participation in another investigational therapeutic study\n* Inability to comply with study procedures as assessed by the investigator based on objective criteria, including but not limited to:\n\n  * Significant language barrier in the absence of adequate translation support\n  * Social or geographic situation preventing follow-up and adherence to visit schedule\n  * Ongoing substance abuse likely to interfere with protocol compliance\n  * Documented cognitive or functional impairment not otherwise covered under legal protection","18 Years",{"count":51,"type":20},180,"INTERVENTIONAL",[54],"PHASE3","Phase III comparative, open-label, randomized (1:1) trial designed to evaluate the efficacy of reducing the total dose of PTCy to 70 mg\u002Fkg on GREFS compared to the standard dose of 100 mg\u002Fkg, in patients undergoing haploidentical HSCT for the treatment of a hematological malignancy, two years after HSCT.",[57,26,58],"GVHD - Graft-Versus-Host Disease","Haploidentical Stem Cell Transplantation",[60,61,62,63],"Cyclophosphamide toxicities","Cyclophosphamide dose reduction","Graft-Versus-Host Disease: GVHD","Hematopoietic stem cell transplantation","2026-05-07",{"date":66,"type":33},"2026-05-12",{"date":68,"type":20},"2026-06",{"date":70,"type":20},"2030-06",{"name":72,"class":40},"Assistance Publique - Hôpitaux de Paris",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":52,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100629194","phase-2-gecacitinib-pre--during--and-post-hsct-for-patients-with-primary-or-secondary-myelofibrosis-100629194","NCT07471503","Gecacitinib Pre-, During- and Post-HSCT for Patients With Primary or Secondary Myelofibrosis","A Phase 2 Clinical Study of Gecacitinib in Peri-transplant Period of Hematopoietic Stem Cell Transplantation in Patients With Myelofibrosis (MF)","CONTINUUM-MF","Inclusion Criteria:\n\n1. Aged 18-75 years, regardless of gender;\n2. Diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV-MF), or post-essential thrombocythemia myelofibrosis (post-ET-MF) according to the 2022 WHO diagnostic criteria;\n3. Meeting the criteria for intermediate-risk or high-risk groups per the DIPSS-plus classification;\n4. Scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), including transplants from HLA-matched or mismatched related or unrelated donors;\n5. ECOG performance status ≤2 and Karnofsky performance status ≥60%;\n6. Capable of understanding and signing the informed consent form, and able to comply with study and follow-up procedures.\n\nExclusion Criteria:\n\n1. Patients using other JAK inhibitors (except for Gecacitinib) at the time of screening may be enrolled if they switch to Gecacitinib treatment prior to screening.\n2. Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.\n3. Disease progression to accelerated or blast phase (peripheral blood or bone marrow blast percentage ≥10% at any time prior to transplantation).\n4. Presence of significant medical conditions or marked organ dysfunction that cannot be adequately controlled and may affect the completion of this study:\n\n   1. Congestive heart failure classified as New York Heart Association (NYHA) Class III-IV, or documented history of diastolic or systolic dysfunction (e.g., LVEF \\\u003C40% measured by echocardiography), or uncontrolled or unstable angina or myocardial infarction.\n   2. Uncontrolled diabetes (\\>250 mg\u002FdL or \\>13.9 mmol\u002FL).\n   3. Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure \\\u003C160 mmHg, diastolic blood pressure \\\u003C100 mmHg).\n   4. Peripheral neuropathy (≥ Grade 2 per NCI-CTC AE v5.0 criteria).\n   5. Serum creatinine \\>1.5 × ULN.\n   6. ALT or AST \\>2.5 × ULN, or DBIL or TBIL \\>2.0 × ULN.\n5. Patients with any bacterial, viral, or fungal infection not adequately controlled.\n6. HIV-positive at screening, or active hepatitis B virus infection (HBsAg-positive with HBV-DNA positivity or above the normal reference range), or HCV antibody-positive with HCV-RNA positivity.\n7. History of tuberculosis or positive interferon-gamma release assay at screening.\n8. Suspected hypersensitivity to Gecacitinib Hydrochloride, drugs of the same class, or any of their excipients.\n9. Pregnant or breastfeeding women, or patients unwilling to use effective contraception during Gecacitinib treatment and for one week after the last dose.\n10. Patients with any other comorbidities that may interfere with the study or a history of prior malignancies.\n11. Patients unable to take oral tablets.","75 Years",{"count":84,"type":20},39,[86],"PHASE2","The investigators evaluate the efficacy and safety of Gecacitinib in patients with myelofibrosis (MF) before, during, and after allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[89,26],"Myelofibrosis (MF)",[91,26,92],"myelofibrosis","Gecacitinib","2026-03-12",{"date":95,"type":33},"2026-03-13",{"date":97,"type":20},"2026-03-16",{"date":99,"type":20},"2030-04-01",{"name":101,"class":40},"Institute of Hematology & Blood Diseases Hospital, China",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":52,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100629607","phase-1-gecacitinib-in-the-treatment-of-steroid-refractorydependent-chronic-graf-versus-host-disease-cgvhd-100629607","NCT07476872","Gecacitinib in the Treatment of Steroid-Refractory\u002FDependent Chronic Graf Versus Host Disease (cGVHD).","A Single-Arm, Open-Label, Single-Center Phase Ib\u002FIIa Clinical Study of Gecacitinib in the Treatment of Steroid-Refractory\u002FDependent Active Chronic Graf Versus Host Disease (cGVHD).","CONTINUUM-GVHD","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of gender.\n2. Underlying hematologic malignancies or non-malignant disorders having received allogeneic hematopoietic stem cell transplantation.\n3. Diagnosis of active cGVHD according to the 2014 NIH consensus criteria, meeting the definition of steroid-refractory or steroid-dependent cGVHD. Prior lines of cGVHD therapy are not restricted. Definitions are as follows:\n\n   1. Steroid-refractory cGVHD is defined as meeting any of the following criteria: disease progression despite the use of prednisone ≥1 mg\u002Fkg\u002Fday (or equivalent dose of corticosteroids) for at least 1 week; OR, persistent disease symptoms with no improvement despite the use of prednisone ≥0.5 mg\u002Fkg\u002Fday or ≥1 mg\u002Fkg every other day (or equivalent dose of corticosteroids) for at least 4 weeks.\n   2. Steroid-dependent cGVHD is defined as the requirement for a maintenance dose of prednisone \\>0.25 mg\u002Fkg\u002Fday or \\>0.5 mg\u002Fkg every other day (or equivalent dose of corticosteroids) to prevent disease flare or progression, and failure to successfully taper the dose to a lower level in at least 2 separate attempts spaced ≥8 weeks apart.\n4. Platelet count ≥50 × 10⁹\u002FL and absolute neutrophil count (ANC) ≥0.5 × 10⁹\u002FL, without the use of colony-stimulating factors, androgens, erythropoietin, thrombopoietin, or platelet transfusion within 7 days prior to screening.\n5. Adequate major organ function, defined as meeting the following criteria: ALT and AST ≤ 2.5 × upper limit of normal (ULN); direct and total bilirubin ≤ 2.0 × ULN; serum creatinine ≤ 1.5 × ULN.\n6. Stable underlying disease without evidence of progression or relapse.\n7. Karnofsky Performance Status (KPS) ≥ 60%.\n8. Voluntarily participate in this study, provide signed informed consent, demonstrate good compliance, and be able to adhere to the study and follow-up procedures\n\nExclusion Criteria:\n\n1. Post-transplant lymphoproliferative disorder, or loss of full donor chimerism due to other reasons.\n2. Previous use of, or current treatment with, other JAK inhibitors at the time of screening.\n3. History or presence of major diseases or clinically significant organ dysfunction that cannot be adequately controlled by treatment and may interfere with study completion:\n\n   1. Congestive heart failure of New York Heart Association (NYHA) class III-IV, or documented history of diastolic or systolic dysfunction (e.g., left ventricular ejection fraction \\\u003C40% by echocardiography), or uncontrolled\u002Funstable angina or myocardial infarction.\n   2. Uncontrolled diabetes (blood glucose \\>250 mg\u002FdL or \\>13.9 mmol\u002FL).\n   3. Hypertension that cannot be adequately controlled to systolic blood pressure \\\u003C160 mmHg and diastolic blood pressure \\\u003C100 mmHg despite combination antihypertensive therapy.\n   4. Peripheral neuropathy (Grade 2 or higher per NCI-CTCAE v5.0 criteria).\n4. Patients with any uncontrolled bacterial, viral, or fungal infection.\n5. Positive for HIV at screening, or active hepatitis B virus infection (HBsAg positive and HBV-DNA positive or above the upper limit of normal), or positive for HCV antibody with detectable HCV-RNA.\n6. History of tuberculosis or positive interferon-γ release assay at screening.\n7. Concurrent use of strong CYP3A4 inhibitors.\n8. History of progressive multifocal leukoencephalopathy.\n9. Known or suspected hypersensitivity to Gecacitinib hydrochloride, drugs of the same class, or any of their excipients.\n10. Pregnant or lactating women, or patients unwilling to use effective contraception during Gecacitinib treatment and for 1 week after the last dose.\n11. Inability to swallow oral tablets.",{"count":111,"type":20},33,[113,86],"PHASE1","This study aims to evaluate the safety and efficacy of Gecacitinib in patients with steroid-refractory\u002Fdependent active chronic graft versus host disease (cGVHD).",[116,26],"cGVHD",[116,92,26],{"date":119,"type":33},"2026-03-17",{"date":97,"type":20},{"date":122,"type":20},"2028-11-01",{"name":101,"class":40},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":52,"phases":133,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100628019","the-efficacy-and-safety-of-stereotactic-radiotherapy-bridging-allogeneic-hematopoietic-stem-cell-transplantation-for-the-treatment-of-hematological-malignance-patients-with-extramedullary-infiltrating-100628019","NCT07456189","The Efficacy and Safety of Stereotactic Radiotherapy Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Hematological Malignance Patients With Extramedullary Infiltrating","Inclusion Criteria:\n\nSubjects who meet all of the following criteria are eligible for enrollment in this study:\n\n* Age between 18 and 60 years.\n* A confirmed diagnosis of a hematologic malignancy, including but not limited to Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myeloid Leukemia (CML), Myelodysplastic Syndromes (MDS), Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma (HL), and Multiple Myeloma (MM).\n* Diagnosis of extramedullary disease\u002Flesions confirmed by one of the following: pathological biopsy, cytology, or at least one imaging modality (including PET-CT, contrast-enhanced CT, or contrast-enhanced MRI).\n* Presence of a suitable donor and scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n* Karnofsky Performance Status (KPS) score \\> 60% or Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2.\n* Has not participated in any other clinical trial involving cell-based or immunotherapies for the treatment of the primary disease.\n* The subject voluntarily agrees to participate in the study, demonstrates good compliance, and is willing to cooperate with follow-up procedures.\n* A signed informed consent form must be obtained prior to the initiation of any study-related procedures. For subjects aged 18 years or older, consent is to be provided by the subject or their immediate family member. If, in the physician's judgment, obtaining consent directly from the subject is not in the patient's best interest regarding their medical condition, the informed consent form may be signed by the legal guardian or an immediate family member of the patient\n\nExclusion Criteria:\n\n* Previous history of one or more autologous or allogeneic stem cell transplants prior to enrollment.\n* Uncontrolled infection at the time of enrollment, or requirement for mechanical ventilatory assistance, or hemodynamic instability.\n* Severe organ dysfunction, including but not limited to hepatic or renal impairment, and heart failure.\n* Evidence of active HIV replication; positive HCV antibody and detectable HCV-RNA within 90 days prior to enrollment; or positive HBsAg. Known seropositivity for HIV or active hepatitis C virus.\n* Presence of psychiatric disorders or any other condition that, in the investigator's opinion, would compromise the subject's ability to cooperate with study treatment and monitoring requirements.\n* Inability or unwillingness to provide written informed consent.\n* Any other condition or circumstance that, in the judgment of the investigator, may pose a risk to the subject or prevent the subject from meeting or fulfilling the study requirements.","60 Years",{"count":132,"type":20},20,[134],"NA","Application of Stereotactic Body Radiotherapy (SBRT) Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Adult Hematological Malignance Patients with Extramedullary Lesions. This study aims to improve transplantation outcomes with extramedullary lesions. The investigators aim to study the Post-Transplantation Evaluation of Disease-Free Survival, Overall Survival, Treatment-Related Mortality, Cumulative Recurrence Rate, Post-Transplantation Complications, and Safety Data.",[26,137],"Hematologic Cancer","2026-03-04",{"date":140,"type":33},"2026-03-06",{"date":142,"type":20},"2026-04-14",{"date":144,"type":20},"2028-03-01",{"name":101,"class":40},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":52,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":4},"100627042","phase-2-efficacy-and-safety-of-olverembatinib-plus-inotuzumab-ozogamicin-as-first-line-consolidation-therapy-followed-by-hsct-in-ph-all-100627042","NCT07443488","Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Therapy Followed by HSCT in Ph+ ALL","A Study on the Efficacy and Safety of Olverembatinib Combined With Inotuzumab Ozogamicin as First-Line Consolidation Therapy Bridging to Hematopoietic Stem Cell Transplantation in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* (1) Clearly diagnosed acute lymphoblastic leukemia, with Philadelphia chromosome positivity or BCR-ABL fusion gene positivity; with CD22 expression on the surface of leukemia cells; failure to achieve minimal residual disease (MRD) negativity after first induction chemotherapy (BCR-ABL fusion gene level ≥ 10-⁴), where the induction regimen is standard chemotherapy combined with any tyrosine kinase inhibitor targeting BCR-ABL1.\n* (2) Age greater than or equal to 18 years.\n* (3) Able to provide informed consent independently.\n* (4) Must have adequate organ function: renal and hepatic functions as follows: AST, ALT, and ALP less than 2 times the upper limit of normal (ULN), total bilirubin less than 1.5 times ULN; creatinine clearance greater than 50 mL\u002Fmin; pancreatic function: serum amylase not exceeding 1.5 times ULN, serum lipase not exceeding 1.5 times ULN; normal cardiac function: ejection fraction (EF) \\> 60%, pulmonary artery systolic pressure ≤ 50 mmHg.\n* (5) Negative for HIV, HBV, and HCV.\n* (6) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n* (7) Informed consent must be signed before the start of study procedures. For subjects aged 18 years and above, informed consent should be signed by the patient themselves or their immediate family members. Considering the patient's condition, if signing by the patient themselves is detrimental to treatment, the legal guardian or immediate family member may sign the informed consent.\n\nExclusion Criteria:\n\n* (1) Mixed lineage leukemia;\n* (2) Involvement of the central nervous system or extramedullary infiltration;\n* (3) Patients with concurrent other malignancies; or those assessed by the investigator as having concomitant diseases that severely endanger the patient's life or affect the completion of the study;\n* (4) Patients with severe allergy to the components or excipients of InO (≥ Grade 3);\n* (5) History of clinically significant liver diseases, such as hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS); or severe\u002Funcontrolled liver diseases, such as cirrhosis, decompensated liver disease, acute or chronic hepatitis;\n* (6) Active cardiac disease, defined as one or more of the following: history of any cardiac or vascular disease; history of uncontrolled or symptomatic angina; myocardial infarction within 6 months prior to study enrollment; history of arrhythmias requiring medication or with severe clinical symptoms; uncontrolled or symptomatic congestive heart failure (\\> New York Heart Association \\[NYHA\\] Class 2); ejection fraction below the lower limit of normal; pulmonary artery systolic pressure \\> 50 mmHg on echocardiography; or clinical symptoms related to pulmonary hypertension;\n* (7) History of severe cardiovascular events (including myocardial infarction, unstable angina, severe arrhythmias, congestive heart failure, etc.) during previous tyrosine kinase inhibitor (TKI) treatment for chronic myeloid leukemia (CML);\n* (8) Abnormal coagulation function;\n* (9) Known seropositivity for HIV or active hepatitis C virus;\n* (10) Patients with psychiatric disorders or other conditions that prevent compliance with study treatment and monitoring requirements;\n* (11) Inability or unwillingness to sign the consent form;\n* (12) Pregnant or lactating women;\n* (13) Patients assessed by the investigator as ineligible due to other special circumstances.",{"count":132,"type":20},[86],"To study the minimal residual disease (MRD) clearance rate of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation chemotherapy in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who have not achieved MRD remission after initial induction chemotherapy.",[26,157],"Ph+ ALL","2026-02-27",{"date":160,"type":33},"2026-03-02",{"date":162,"type":20},"2026-03-14",{"date":164,"type":20},"2027-10-31",{"name":101,"class":40},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":130,"enrollmentInfo":173,"targetDuration":4,"studyType":52,"phases":174,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":181,"leadSponsor":183,"locationsCount":4},"100627567","phase-2-the-efficacy-and-safety-of-luspatercept-in-improving-early-anemia-after-hsct-100627567","NCT07450313","The Efficacy and Safety of Luspatercept in Improving Early Anemia After HSCT","A Clinical Study on the Efficacy and Safety of Luspatercept in Improving Early Anemia After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* 1\\. Diagnosis of malignant hematological tumors and undergoing allogeneic hematopoietic stem cell transplantation.\n* 2\\. Expected survival after transplantation exceeds 1 month.\n* 3\\. Age 18-60 years.\n* 4\\. Hemoglobin ≤60 g\u002FL on day 0 after transplantation.\n* 5\\. Eastern Cooperative Oncology Group (ECOG) score 0-2.\n* 6\\. Able to independently sign the informed consent form.\n* 7\\. The informed consent form must be signed before the start of the study procedures. For individuals aged 18 years and above, the informed consent form should be signed by the patient themselves or their immediate family members. Considering the patient's condition, if signing by the patient themselves is not conducive to treatment, the legal guardian or immediate family member should sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Uncontrolled infection at the time of enrollment, or requiring mechanical ventilation or hemodynamic instability;\n* 2\\. Severe organic damage: hepatic or renal impairment;\n* 3\\. Occurrence of any of the following within 6 months prior to the study: myocardial infarction, severe\u002Funstable angina pectoris, congestive heart failure, or cerebrovascular accident, including transient ischemic attack;\n* 4\\. Presence of psychiatric disorders or other conditions that may compromise compliance with study treatment and monitoring requirements. Failure to sign the informed consent form;\n* 5\\. Inability or unwillingness to sign the consent form;\n* 6\\. Participation in other transplant-related clinical studies;\n* 7\\. Other circumstances deemed by the investigator as potentially affecting the study or ethics, including drug allergies, patient non-compliance with study procedures, or involvement of the research center staff and their immediate relatives.",{"count":132,"type":20},[86],"This study aims to evaluate whether luspatercept can improve the efficacy and safety of anemia treatment in patients with hematologic malignancies after allogeneic hematopoietic stem cell transplantation.",[26],[178],"anemia，HSCT",{"date":138,"type":33},{"date":162,"type":20},{"date":182,"type":20},"2027-06-14",{"name":101,"class":40},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":192,"maxAge":49,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":73},"100624367","neurocognitive-deficit-after-paediatric-transplantation-understanding-the-role-of-environment-and-physical-function-100624367","NCT07408713","Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function","The NATURE Study (Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function)","NATURE","Inclusion Criteria:\n\n1. Recipient of allogeneic HSCT in the study period\n2. HSCT at the pediatric ward\n3. Age \\\u003C18 years at referral to HSCT\n4. Signed informed consent\n\nExclusion Criteria:\n\n1\\) Inability of legal guardian to speak and understand Danish","0 Years",{"count":194,"type":20},100,"Hematopoietic stem cell transplantation (HSCT) is a potentially life-saving treatment for children with relapsed or resistant leukemia and other life-threatening hematological and hereditary disorders. In Denmark, around 25 children undergo allogeneic HSCT every year, of these approximately 85-90% survive into adulthood.\n\nThe goal of this observational study is to learn about neurocognitive outcomes in children undergoing (HSCT) and to understand which clinical, physical, and environmental factors may affect neurocognitive development during the first year after transplant. The main questions it aims to answer are:\n\nHow does neurocognitive function change from before HSCT to one year after transplantation in pediatric patients?\n\nWhich clinical, physical, and environmental factors are linked to better or worse neurocognitive outcomes?\n\nParticipants will:\n\nComplete neurocognitive tests before HSCT and at 1-year follow-up, covering intelligence, memory, attention, executive function, processing speed, and motor skills.\n\nUndergo physical tests before HSCT, at hospital discharge, at 6-months follow-up, and at 1-year follow-up, including muscle strength, mobility, endurance, balance, and cardiopulmonary fitness (only at 1-year follow-up).\n\nWear activity trackers to measure physical activity and sedentary time during hospitalization at 6 months and 1-year post-HSCT.\n\nComplete questionnaires about sleep, pain, quality of life, fatigue, family background, and exposure to outdoor and green spaces.\n\nHave medical records reviewed for treatment-related side effects, immune recovery, inflammation, and pain management.\n\nThis study will help understand how neurocognitive function develops after HSCT in children and which factors (clinical, physical, or environmental) may support better recovery and well-being.",[26,197,198,199,200,201,202,203],"Pediatric Cancer","Pediatric Patients","Late Effect","Toxicity","Neurocognitive Dysfunction","Physical Function","Physical Capacity","2026-02-18",{"date":206,"type":33},"2026-02-20",{"date":208,"type":20},"2026-02-15",{"date":210,"type":20},"2031-12-31",{"name":212,"class":40},"Rigshospitalet, Denmark",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":52,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":73},"100617669","phase-1-romiplostim-n01-for-platelet-recovery-after-haploidentical-hsct-100617669","NCT07321626","Romiplostim N01 for Platelet Recovery After Haploidentical HSCT","Efficacy and Safety of Romiplostim N01 in Promoting Platelet Reconstruction After Haploidentical Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies","Inclusion Criteria:\n\nPatients with malignant hematologic diseases scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) Age ≥18 years, male or female. ECOG performance status 0-1. Estimated life expectancy \\>6 months. Adequate renal function, defined as:serum creatinine ≤1.5 × upper limit of normal (ULN);Blood urea nitrogen (BUN) ≤1.5 × ULN.\n\nAdequate hepatic function, defined as:Alanine aminotransferase (ALT) ≤2 × ULN.Aspartate aminotransferase (AST) ≤2 × ULN.Total bilirubin ≤1.5 × ULN.\n\nAbility to understand and sign informed consent, and willingness to comply with all study requirements.\n\nExclusion Criteria:\n\nUncontrolled active infection or other active malignancy that could interfere with study participation.\n\nSevere cardiovascular disease, including:New York Heart Association (NYHA) Class III-IV heart failure;Uncontrolled hypertension or hypotension;History of or high risk for thromboembolic events.\n\nReceiving anticoagulation therapy for thrombotic events. Known hypersensitivity to romiplostim or similar agents. Use of rh-TPO or any thrombopoietin receptor agonist (TPO-RA) within 30 days prior to enrollment.\n\nParticipation in another interventional clinical study within 30 days prior to enrollment.\n\nAny other condition that, in the investigator's judgment, makes the patient unsuitable for the study.",{"count":221,"type":20},130,[113],"This is a prospective, randomized, controlled clinical study designed to evaluate the efficacy and safety of Romiplostim N01 in promoting platelet engraftment after haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) in patients with hematologic malignancies.\n\nA total of 130 patients who undergo haplo-HSCT for acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or other hematologic malignancies will be enrolled and randomized 1:1 into a treatment group and a control group. The treatment group will receive Romiplostim N01 subcutaneously once weekly at a starting dose of 5 µg\u002Fkg, with dose adjustments based on platelet counts (maximum 10 µg\u002Fkg), for up to 4 weeks or until platelet counts reach ≥100 × 10⁹\u002FL. The control group will not receive rh-TPO or any thrombopoietin receptor agonist (TPO-RA) therapy. Supportive care including transfusions and growth factors (G-CSF, ESA) is allowed in both groups.\n\nThe primary endpoint is the cumulative platelet engraftment rate by day +21 post-transplant, defined as sustained platelet counts \\> 20 × 10⁹\u002FL for at least 7 consecutive days without transfusion. Secondary endpoints include median time to platelet engraftment, median time to achieve platelet counts ≥ 50 × 10⁹\u002FL and ≥ 100 × 10⁹\u002FL, total platelet transfusion volume, erythroid and neutrophil responses within 4 weeks, and overall hematopoietic recovery. Safety endpoints include the incidence of adverse events, thromboembolic events, and treatment-related serious adverse events.\n\nThe study aims to determine whether early administration of Romiplostim N01 can accelerate platelet recovery and reduce bleeding risk in patients undergoing haplo-HSCT, thereby improving post-transplant outcomes.",[225,226,227,26],"Acute Myeloid Leukemia","MDS (Myelodysplastic Syndrome)","Delayed Platelet Engraftment","RECRUITING","2026-01-26",{"date":231,"type":33},"2026-01-28",{"date":233,"type":33},"2025-06-01",{"date":235,"type":20},"2027-12",{"name":237,"class":40},"First Affiliated Hospital of Zhejiang University",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":52,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":4},"100617282","phase-2-study-of-treosulfan-based-conditioning-for-hsct-in-nijmegen-breakage-syndrome-100617282","NCT07316595","Study of Treosulfan-Based Conditioning for HSCT in Nijmegen Breakage Syndrome","A Clinical Study of the Efficacy and Safety of Conditioning With Low Doses of Treosulfan Before Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Nijmegen Breakage Syndrome","Inclusion Criteria:\n\n* genetically confirmed Nijmegen breakage syndrome\n* availability of informed consent for study participation, signed by the patient (ages 14 to 21) and\u002For their legal representative (ages 0 to 18).\n* absence of contraindications to HSCT based on the patient's somatic status.\n\nExclusion Criteria:\n\n* other DNA repair deficiency syndromes (both specified and unspecified)","21 Years",{"count":247,"type":20},24,[86],"Nijmegen breakage syndrome is one of the DNA repair defect disorders. A characteristic feature of these syndromes is a predisposition to the development of malignant neoplasms. The only curative option for the combined immunodeficiency in Nijmegen breakage syndrome is allogeneic hematopoietic stem cell transplantation (HSCT). In addition to correcting the immunodeficiency, HSCT can reduce the risk of developing hematopoietic tumors.\n\nDue to the increased sensitivity of cells in patients with Nijmegen breakage syndrome to alkylating drugs, the use of standard myeloablative conditioning regimens for this disease significantly increases the risks of toxic complications and transplant-related mortality.\n\nTreosulfan is an alkylating agent that has demonstrated efficacy with comparatively low risks of toxic complications when used as part of conditioning prior to allogeneic HSCT for various diseases in patients of all age groups. There is currently experience using treosulfan in patients with Nijmegen breakage syndrome at reduced doses (21 and 30 g\u002Fm²). However, a number of questions remain unresolved. Based on our previous experience, a dose of 21 g\u002Fm² is sufficient for patients with Nijmegen breakage syndrome without a malignant disease, as it ensures good graft function (a high probability of full donor chimerism and control of the immunodeficiency). At the same time, there is reason to believe that this dose is insufficient to provide an antitumor effect from the conditioning.\n\nWe are planning a multicenter study to investigate treosulfan-based conditioning in patients with Nijmegen breakage syndrome, which will stratify patients based on the presence or absence of malignant disease. Patients without a tumor will receive treosulfan at a dose of 21 g\u002Fm², and patients with a tumor will receive 30 g\u002Fm².",[26,251,252],"Nijmegen Breakage Syndrome","Treosulfan Based Conditioning","2025-12-18",{"date":255,"type":33},"2026-01-05",{"date":257,"type":20},"2025-12-30",{"date":259,"type":20},"2030-12-31",{"name":261,"class":40},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":52,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100613025","phase-2-zuberitamab-for-ebv-infection-post-allo-hsct-100613025","NCT07261215","Zuberitamab for EBV Infection Post-Allo-HSCT","A Study on the Efficacy and Safety of Zuberitamab as First-Line Preemptive Therapy for EBV Infection Following Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Underwent allogeneic hematopoietic stem cell transplantation (HSCT).\n2. Documented EBV infection, defined as either:\n\n   EBV DNAemia (EBV-DNA ≥400 copies\u002FmL in plasma), or Pathologically confirmed EBV-associated lymphoproliferative disease with positive EBER by in situ hybridization.\n3. Age ≥18 years, regardless of gender.\n4. Negative for HIV, HBV, and HCV.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n6. Provision of signed informed consent prior to any study-related procedures. For patients aged 18 or above, consent must be provided by the patient themselves or an immediate family member. If obtaining consent directly from the patient is deemed medically detrimental to their condition, consent may be provided by a legal guardian or an immediate family member.\n\nExclusion Criteria:\n\n* 1\\. Presence of uncontrolled infection requiring mechanical ventilation or hemodynamic instability at the time of enrollment.\n\n  2\\. Diagnosis of clinically significant severe hepatic insufficiency (defined as Child-Pugh Class C) within 5 days prior to enrollment.\n\n  3\\. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding 5 times the upper limit of normal (ULN), or serum total bilirubin exceeding 2 times ULN, within 5 days prior to enrollment.\n\n  4\\. Diagnosis of end-stage renal dysfunction with a creatinine clearance rate of \\\u003C10 mL\u002Fmin within 5 days prior to enrollment.\n\n  5\\. Concurrent diagnosis of moderate hepatic insufficiency (defined as Child-Pugh Class B) and moderate renal dysfunction (defined as creatinine clearance rate \\\u003C50 mL\u002Fmin).\n\n  6\\. Cardiac function or disease meeting any of the following criteria:\n  1. Long QT syndrome or QTc interval \\>480 ms.\n  2. Complete left bundle branch block, second-degree or third-degree atrioventricular block.\n  3. Severe, uncontrolled arrhythmia requiring pharmacological intervention.\n  4. New York Heart Association (NYHA) functional classification ≥ Class II.\n  5. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n  6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other clinically significant arrhythmia requiring treatment within 6 months prior to enrollment; history of clinically significant pericardial disease; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n\n     7\\. Presence of uncontrolled severe acute graft-versus-host disease (aGVHD). 8. Evidence of active HIV replication prior to enrollment; detectable HCV antibody and HCV-RNA positivity within 90 days prior to enrollment; or HBsAg positivity. Known seropositivity for HIV or active hepatitis C virus.\n\n     9\\. Presence of psychiatric disorders or other conditions that would compromise the patient's ability to comply with study treatment and monitoring requirements.\n\n     10\\. Inability or unwillingness to provide written informed consent. 11. Patients deemed ineligible by the investigator due to other specific circumstances.",{"count":132,"type":20},[86],"EBV DNAemia is defined as the presence of EBV-DNA load in peripheral blood exceeding the normal threshold, serving as a key diagnostic indicator for EBV-associated post-transplant lymphoproliferative disorder (EBV-PTLD). According to the European Conference on Infections in Leukemia (ECIL-6) guidelines, regular monitoring of peripheral blood EBV-DNA levels via quantitative real-time PCR (qPCR) is recommended starting from the first month after allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a weekly frequency sustained for at least 4 months post-transplant. For HSCT patients who develop EBV DNAemia, preemptive therapy should be initiated promptly. EBV-PTLD is a serious complication that may progress rapidly; if not diagnosed and treated in a timely manner, mortality rates can reach 60-80%. Current guidelines recommend CD20 monoclonal antibody (rituximab) as the first-line preemptive treatment. The response rate to rituximab is approximately 84%. The typical regimen consists of 375 mg\u002Fm² per dose, administered weekly, with 1-4 doses generally sufficient to achieve treatment goals. However, a subset of patients exhibits poor response to first-line therapy and requires second-line interventions, such as EBV-specific cytotoxic T lymphocytes (EBV-CTLs), donor lymphocyte infusion, or combination chemotherapy.\n\nZuberitamab is a novel anti-CD20 monoclonal antibody and the first Class 1 innovative biologics targeting CD20 developed in China. Preclinical studies have demonstrated that zuberitamab exhibits stronger antibody-dependent cellular cytotoxicity (ADCC) activity compared to rituximab. In a pivotal Phase III registrational clinical study, zuberitamab combined with CHOP (Hi-CHOP) was evaluated head-to-head against R-CHOP in patients with diffuse large B-cell lymphoma (DLBCL). The results showed an improvement in the complete response (CR) rate by more than 8% (85.7% vs. 77.3%, P = 0.038). These findings indicate that zuberitamab holds significant advantages over rituximab in terms of both biological activity and clinical efficacy. Based on this evidence, we have initiated a Phase II clinical trial to evaluate the efficacy and safety of zuberitamab as first-line preemptive therapy for EBV infection. This is a prospective Phase II clinical trial enrolling patients with EBV infection following transplantation. Zuberitamab will be administered as first-line preemptive therapy.",[26,273],"EBV Infection","2025-11-21",{"date":276,"type":33},"2025-12-03",{"date":278,"type":20},"2026-01-14",{"date":280,"type":20},"2026-10-31",{"name":101,"class":40},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":52,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":4},"100612867","phase-2-modified-conditioning-regimen-for-cml-bp-100612867","NCT07259161","Modified Conditioning Regimen for CML-BP","Prospective, Single-Arm Study on the Efficacy of a Reduced-Toxicity Conditioning Regimen Containing Thiotepa and Melphalan for Patients With Blast Phase Chronic Myeloid Leukemia","Inclusion Criteria:\n\n* (1) Confirmed diagnosis of blast-phase chronic myeloid leukemia, with diagnostic criteria referring to the 2020 Chinese Guidelines for Diagnosis and Treatment of Chronic Myeloid Leukemia.\n\nDiagnostic criteria for chronic myeloid leukemia: Typical clinical manifestations combined with the presence of Philadelphia chromosome and\u002For BCR-ABL fusion gene positivity confirm the diagnosis.\n\nDiagnostic criteria for blast phase:\n\n1. Peripheral blood or bone marrow blasts ≥20%\n2. Aggregates of blasts on bone marrow biopsy\n3. Extramedullary blast cell infiltration (2) Age ≥18 years (3) Ability to provide self-signed informed consent (4) Must meet adequate organ function requirements:\n\nRenal and hepatic function as follows:\n\nAST, ALT and ALP \\\u003C2× upper limit of normal (ULN) Total bilirubin \\\u003C1.5× ULN Creatinine clearance \\>50 mL\u002Fmin\n\nPancreatic function:\n\nSerum amylase ≤1.5× ULN Serum lipase ≤1.5× ULN\n\nNormal cardiac function:\n\nEjection fraction (EF) \\>60% Pulmonary artery systolic pressure ≤50 mmHg (5) HIV negative, HBV negative, HCV negative (6) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2 (7) Signed informed consent must be obtained before study procedures begin. For subjects aged 18 years or older, informed consent shall be signed by the patient themselves or direct family members. Considering the patient's medical condition, if the patient's own signature is medically inadvisable, the informed consent shall be signed by a legal guardian or the patient's direct family member.\n\nExclusion Criteria:\n\n* 1\\. (1) Patients with previous autologous or allogeneic stem cell transplantation; (2) Patients concurrently diagnosed with other malignant tumors; patients assessed by investigators as having concomitant diseases that severely endanger their life safety or affect their ability to complete this study; (3) Patients with psychiatric disorders or other medical conditions that cannot comply with the requirements of study treatment and monitoring; (4) Patients unable or unwilling to sign the consent form; (5) Pregnant or lactating women; (6) Patients assessed by investigators as ineligible due to other special circumstances.",{"count":290,"type":20},40,[86],"Study on the Efficacy and Safety of a Reduced-Toxicity Conditioning Regimen Containing Thiotepa and Melphalan in Patients with Blast Phase Chronic Myeloid Leukemia",[294,26],"CML,Blast Phase",{"date":296,"type":33},"2025-12-02",{"date":298,"type":20},"2025-12-15",{"date":300,"type":20},"2029-09-14",{"name":101,"class":40},{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":309,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":312,"conditions":313,"keywords":322,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100605065","cardiovascular-complications-in-patients-undergoing-allogeneic-hematopoietic-stem-cell-transplantation-100605065","NCT07157670","Cardiovascular Complications in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.","ALLOCARDIOTOX","Inclusion Criteria:\n\n* Age ≥ 15 years\n* Informed about the study and without objection to participation (or with consent from legal guardians)\n* Undergoing allogeneic HSCT\n\nExclusion Criteria:\n\n* Patient not followed up at the participating center\n* Pregnant or breastfeeding women\n* Patient not affiliated with social security\n* Patient under guardianship, curatorship, or legal protection","15 Years",{"count":311,"type":20},400,"Allogeneic hematopoietic stem cell transplantation (HSCT) represents a major therapeutic strategy for malignant hematologic diseases, with the number of procedures steadily increasing in France each year. Conditioning and maintenance regimens carry a risk of both short- and long-term cardiotoxicity, leading to serious cardiovascular events including acute coronary syndrome (ACS), cardiac dysfunction, arrhythmias, pulmonary hypertension, and pericardial effusion. The pathophysiology of cardiotoxicity in HSCT patients remains poorly understood.\n\nIt is therefore crucial to investigate underlying mechanisms and identify predictive factors of cardiotoxicity in order to provide appropriate cardiological follow-up and management. Current European Society of Cardiology guidelines recommend routine monitoring of HSCT patients with echocardiography and cardiac biomarkers (NT-proBNP, troponin), although these recommendations are based on small-scale studies. The cardiodepressor factor DPP3 has shown promising results in cardio-oncology, with a causal role in anthracycline-induced cardiac dysfunction. Its role in HSCT-related cardiotoxicity requires further evaluation.\n\nThis multicenter study of HSCT recipients will be a valuable resource, enabling a better understanding of the pathophysiology of cardiotoxicity and prognosis. It will highlight imaging (echocardiography, calcium score, supra-aortic Doppler), electrocardiographic, and biological markers (including DPP3) associated with prognosis.",[314,315,26,316,317,318,319,320,321],"Cardiotoxicity","DPP3","Allogeneic Hematopoietic Stem Cell Transplantation","ACS - Acute Coronary Syndrome","Cardiac Dysfunction","Arrythmia, Cardiac","Pulmonary Hypertension","Machine Learning",[315,26,314,323,321],"Allogeneic hematopoietic stem cell transplantation","2025-09-02",{"date":326,"type":33},"2025-09-05",{"date":328,"type":20},"2025-09-15",{"date":330,"type":20},"2028-09-15",{"name":72,"class":40},{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":339,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":52,"phases":341,"briefSummary":342,"conditions":343,"keywords":347,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":4},"100575229","phase-2-reduced-dose-conditioning-regimen-containing-tbi-in-hsct-treating-elderly-patients-with-aplastic-anemia-100575229","NCT06769568","Reduced-dose Conditioning Regimen Containing TBI in HSCT Treating Elderly Patients With Aplastic Anemia","The Safety and Efficacy of Reduced-dose Conditioning Regimen Containing TBI in Hematopoietic Stem Cell Transplantation Treating Elderly Patients With Aplastic Anemia","Inclusion Criteria:\n\n* ( 1 ) Diagnosis of aplastic anemia, including very severe aplastic anemia, severe aplastic anemia, chronic aplastic anemia and hepatitis-associated aplastic anemia.\n\n( 2 ) Age older than or equal to 50 years old. ( 3 ) Informed consent can be signed by themselves. ( 4 ) HIV negative, HBV, HCV negative. ( 5 ) Informed consent must be signed before the start of the study procedure. Informed consent must be signed by the patient or immediate family members who are 18 years old or older. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.\n\nExclusion Criteria:\n\n* ( 1 ) Patients who underwent more than one time of transplantation before enrollment ; ( 2 ) Uncontrolled infection, mechanical ventilation or hemodynamic instability at the time of enrollment ; ( 3 ) Diagnosis of clinically significant severe liver dysfunction ( defined as Child-Pugh C grade ) within 5 days before enrollment ; or within 5 days before enrollment, AST or ALT was 5 times higher than the upper limit of normal, or serum total bilirubin was 2 times higher than the upper limit of normal ; ( 4 ) End-stage renal insufficiency was diagnosed within 5 days before enrollment, and creatinine clearance rate was less than 10ML \u002F min.\n\n( 5 ) Simultaneous diagnosis of moderate hepatic insufficiency and moderate renal insufficiency ( moderate hepatic insufficiency was defined as Child-Pugh B grade ; moderate renal insufficiency was defined as creatinine clearance rate less than 50ML \u002F min ).\n\n( 6 ) In addition to localized basal cell or squamous cell skin cancer or treatment conditions ( such as lymphoma ), there are active solid tumor malignant tumors.\n\n( 7 ) There was active HIV replication before enrollment. HCV antibody positive, HCV-RNA positive, or HBsAg positive could be detected within 90 days before enrollment. The serological response to HIV or active hepatitis C virus is known to be positive.\n\n( 8 ) Having a mental illness or other condition that does not cooperate with the requirements of research, treatment and monitoring.\n\n( 9 ) unable or unwilling to sign the consent form. ( 10 ) Patients with other special conditions who were assessed as unqualified by the researchers.","50 Years",{"count":132,"type":20},[86],"The TBI-containing reduced-dose conditioning regimen was used to treat elderly patients with aplastic anemia who received hematopoietic stem cell transplantation. The overall survival rate, GVHD-free survival rate, all-cause mortality,et al were studied. The modified conditioning regimen included TBI 2Gy, -7d, busulfan 3.2mg \u002F kg-6d ; fludarabine 30mg \u002F m2 \u002F d-5 \\~ -1d ; cyclophosphamide 25-30mg \u002F kg \u002F d-5 \\~ -2d ; ATG ( rabbit ) 2 mg \u002F kg \u002F d-5 \\~ -1d.",[344,26,345,346],"Aplastic Anaemia","TBI","Old Age",[348,26,349,350],"aplastic anemia","old age","conditioning regimen","2025-01-07",{"date":353,"type":33},"2025-01-10",{"date":355,"type":20},"2025-01-31",{"date":357,"type":20},"2028-09-30",{"name":101,"class":40},{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":52,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":4},"100566726","phase-2-olverembatinib-as-maintenance-therapy-or-preemptive-therapy-after-allo-hsct-in-phall-100566726","NCT06658925","Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Ph+ALL","The Safety and Efficacy of Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Adult Ph + Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* ( 1 ) Acute lymphoblastic leukemia with positive Ph chromosome or BCR \u002F ABL fusion gene ; after allogeneic hematopoietic stem cell transplantation, and survived for more than 30 days after transplantation.\n\n( 2 ) Age older than or equal to 18 years old ( 3 ) Informed consent can be signed by themselves. ( 4 ) Adequate organ function must be met : renal function and liver function are as follows : serum creatinine is 2 times lower than the normal upper limit, AST, ALT and ALP are lower than the normal upper limit of 3 times, and total bilirubin is lower than the normal upper limit of 3 times ( if the liver GVHD is clearly diagnosed, less than or equal to 5 × ULN ) ).\n\n( 5 ) HIV negative, HBV and HCV negative. ( 6 ) The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.\n\n( 7 ) Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.\n\nExclusion Criteria:\n\n* ( 1 ) Hematology remission was evaluated at 1 month after transplantation, and complete donor chimerism was achieved.\n\n( 2 ) Severe cardiovascular diseases ( including myocardial infarction, unstable angina pectoris, severe arrhythmia and congestive heart failure, etc. ) occurred during the previous use of the third generations of TKI treatment.\n\n( 3 ) Uncontrolled infection at the time of enrollment ; severe complications of mechanical ventilation or hemodynamic instability ; those who had undergone autologous or allogeneic stem cell transplantation; ( 4 ) The serological reaction of known HIV or active hepatitis C virus is positive ; ( 5 ) suffering from mental illness or other illness and can not cooperate with the research treatment and monitoring requirements ; ( 6 ) being unable or unwilling to sign the consent ; ( 7 ) pregnant or lactating women ; ( 8 ) Patients with other special conditions who were assessed as unqualified by the researchers.",{"count":367,"type":20},50,[86],"This study is a single-center, prospective, single-arm exploratory study. Ph + acute lymphoblastic leukemia patients treated with allogeneic hematopoietic stem cell transplantation were recruited from the Stem Cell Transplantation Center of the Hospital of Hematology, Chinese Academy of Medical Sciences. The number of patients is expected to be 50 cases. The enrolled patients plan to receive Olverembatinib as a post-transplant treatment regimen, including maintenance therapy to prevent recurrence and preemptive treatment. Hematopoietic reconstitution ( neutrophil \\> 0.5 × 10 \\^ 9 \u002F L, platelet \\> 50 × 10 \\^ 9 \u002F L ) was evaluated after enrollment. From 2 months to 3 months after transplantation, Olverembatinib 40 mg QOD was added for maintenance treatment until 2 years after transplantation. During maintenance treatment, Olverembatinib dose ( dose range 20 mg QOD to 40 mg QOD ) can be adjusted according to blood picture, biochemical index or other oral drugs ( triazole drugs, etc. ).",[371,26,372],"Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)","Tyrosine Kinase Inhibitor","2024-10-23",{"date":375,"type":33},"2024-10-26",{"date":377,"type":20},"2024-11-01",{"date":379,"type":20},"2027-08-31",{"name":101,"class":40},{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":17,"minAge":388,"maxAge":49,"enrollmentInfo":389,"targetDuration":4,"studyType":52,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":404,"leadSponsor":406,"locationsCount":73},"100564146","comparison-of-intralipid-with-smof-lipid-following-hsct-100564146","NCT06625372","Comparison of Intralipid With SMOF Lipid Following HSCT","Comparison of the Effect of Intralipid Parenteral Nutritional With SMOF Lipid Parenteral Nutritional on Biochemical Markers, Hematologic Markers, and Clinical Outcomes Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)","Inclusion Criteria:\n\n* Willingness to cooperate and complete the informed consent form by the legal guardian of the child;\n* Age ≤ 18 years;\n* Definitive diagnosis of acute leukemia and candidate for hematopoietic stem ● cell transplantation;\n* Eligible for parenteral nutrition support;\n* No contraindications for parenteral nutrition;\n* No history of allergy to egg or soy protein;\n* Absence of severe organ failure or impaired liver function test (bilirubin \\> 2.5 mg\u002FdL).\n\nExclusion Criteria:\n\n* Death of the child earlier than 5 days from the start of the intervention;\n* Unwillingness to continue cooperation during study;\n* Occurrence of side effects during the study;\n* In case of sepsis, hypotension, shock, thrombosis, myocardial infarction, liver dysfunction, the patient will be excluded from the study.","2 Years",{"count":367,"type":20},[134],"The goal of this clinical trial is to have a successful engraftment in after bone transplantation. Acute leukemia patient of both sexes aged 2 to 18 years, who are transplant candidates, participate in this study. Primary hypothesis is Patients receiving SMOF LIPID will have better grafts than patients receiving intralipid. Also, complications after surgery and malnutrition will be less in this group.",[393,26],"Leukemia",[395,396,397,398,399],"mortality","SMOF","Intralipid","Engrafment","Complications","2024-10-12",{"date":402,"type":33},"2024-10-16",{"date":400,"type":33},{"date":405,"type":20},"2025-12",{"name":407,"class":40},"Shahid Beheshti University"]