[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hematopoietic-stem-cell-transplant-hsct\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hematopoietic-stem-cell-transplant-hsct":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,70,98,125,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100625680","phase-2-venetoclax-combined-with-azacitidine-for-consolidation-therapy-in-aml-100625680",false,"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.","ALL","18 Years",{"count":19,"type":20},216,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30],"Acute Myeloid Leukemia","Consolidation Therapy","Venentoclax","High Risk","Hematopoietic Stem Cell Transplant (HSCT)",[26,27,28,32,33],"Allogenice Hematopoietic Stem Cell Transplantation","High risk","RECRUITING","2026-08-04",{"date":37,"type":38},"2026-08-06","ACTUAL",{"date":40,"type":38},"2026-02-01",{"date":42,"type":20},"2028-11-26",{"name":44,"class":45},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100567201","phase-2-pul-042-treatment-in-patients-with-parainfluenza-virus-piv-human-metapneumovirus-hmpv-or-respiratory-syncytial-virus-rsv-100567201","NCT06665100","PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)","Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients With Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) With Documented Viral Infections With PIV, hMPV or RSV","Inclusion Criteria:\n\n* Subjects will be eligible for entry into the study if a nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) by molecular assay by a local laboratory AND subjects must fulfill the following inclusion criteria to be eligible for participation in the study:\n\n  1. Subjects with hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipients of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder.\n  2. Subjects who have undergone active cytotoxic chemotherapy within 6 months or subjects who are on an immunosuppressive therapy (e.g., alemtuzumab, ibrutinib, mycophenolate mofetil, corticosteroids ≥1mg\u002Fkg prednisone equivalent).\n  3. Subjects who are recipients of an allogeneic hematopoietic stem cell transplant (HSCT) must be deemed high risk with an Immunodeficiency Scoring Index (ISI) , of greater or equal to 4.\n  4. Subjects who are recipients of an autologous HSCT must be within 3 months of the transplant procedure.\n  5. Subjects must be symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough and must be dosed within 6 days from the onset of symptoms.\n  6. Chest X-ray with a Radiologic Severity Index (RSI) score of 6 or lower.\n  7. Subjects must have pulse oximetry of hemoglobin saturation ≥ 93% on room air.\n  8. Spirometry (forced expiratory volume in one second \\[FEV1\\] and forced vital capacity \\[FVC\\]) ≥70% of predicted value.\n  9. Adult (≥ 18 years of age).\n  10. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\n  11. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.\n  12. If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\n  13. Ability to understand and give informed consent.\n\nExclusion Criteria:\n\n* Subjects will be excluded if they fulfill any of the following exclusion criteria:\n\n  1. Patients with a pulse oximetry of hemoglobin saturation less than 93% on room air.\n  2. Known history of chronic pulmonary disease (e.g., asthma \\[including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection\\], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.\n  3. Subjects treated for fungal, viral, or bacterial pneumonia in the previous 30 days.\n  4. Exposure to any investigational agent (defined as any non-FDA-approved agent) within 30 days, or 5 half-lives of the investigational agent, whichever is longer, prior to the Screening Visit.\n  5. Allogeneic HSCT recipients with an ISI of 3 or less.\n  6. Autologous HSCT recipients more than 3 months after the transplant procedure.\n  7. Patients with a relapsed and\u002For refractory underlying hematologic malignancy with a life expectancy of less than 2 months.\n  8. HSCT recipients in the pre-engraftment period.\n  9. Chest X-ray with an RSI of \\>6.\n  10. Patients documented to be positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days prior to the Screening Visit, as determined by local testing (additional screening testing is not required).\n  11. Clinically significant bacteremia or fungemia within 7 days prior to the Screening Visit that has not been adequately treated, as determined by the Principal Investigator.\n  12. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.\n  13. Previous exposure to PUL-042 Inhalation Solution.",{"count":55,"type":20},100,[23],"The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with documented viral infections due to PIV, hMPV, or RSV. PUL-042 or a placebo will be administered 3 times over a 6-day period. The total duration of the study will be approximately 30 days.",[59,30],"Hematologic Malignancies","2026-08-03",{"date":35,"type":38},{"date":63,"type":38},"2025-06-27",{"date":65,"type":20},"2027-05",{"name":67,"class":68},"Pulmotect, Inc.","INDUSTRY",12,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100648730","phase-1-study-to-evaluate-the-safety-and-effectiveness-of-withaferin-a-as-a-treatment-to-prevent-gvhd-in-transplant-patients-100648730","NCT07724873","Study to Evaluate the Safety and Effectiveness of Withaferin A as a Treatment to Prevent GvHD in Transplant Patients","A Phase I\u002FII Trial to Assess Safety and Activity of Standardized Withaferin A as GvHD Prophylaxis in Patients Undergoing Matched Related Donor Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. ECOG performance score of 0 or 1\n2. Adequate liver function (Total serum bilirubin \\\u003C twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 3-fold higher than laboratory upper normal limits)\n3. Adequate renal function (creatinine clearance \\> 50 ml\u002Fmin)\n4. Adequate cardiac function (LVEF\\>40%)\n5. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.\n6. Signed, written informed consent\n\nExclusion Criteria: -\n\n1. Known hypersensitivity or contraindications against Withaferin-A.\n2. Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n3. Any medical or psychiatric illness which precludes the participant from giving informed consent\n4. Pregnancy, lactation, or inadequate contraception.",{"count":78,"type":20},54,[80,23],"PHASE1","What is acute Graft versus host disease (aGvHD)? GvHD is a complication that can occur after an allogeneic stem cell transplant resulting in damage to some organs. The death rate of GvHD patients is 15-40%. In GvHD, the donated peripheral blood stem cells or bone marrow view the recipient's body as foreign, and the donated cells\u002Fbone marrow harm the body. aGvHD usually develops in skin, liver or gastrointestinal tract, and symptoms might appear within few weeks after transplant. Symptoms of acute GvHD are observed as skin rash or reddened areas on the skin, yellow discoloration of the skin and\u002For eyes, and abnormal blood test results, nausea, vomiting, diarrhea, or abdominal cramping.\n\nWhat is the current prevention used for GvHD? To prevent development of GvHD many standard drugs like cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cyclophosphamide are given.\n\nWhat is standardized Withaferin-A (SWA)? Withaferin-A (WA) is the main active component of Withania somnifera (Ashwagandha). It has been shown in many studies to have properties of healing and immune-modulation (improving the immune system). Studies have been done in our Clinical Pharmacology Laboratory that have shown a significant beneficial effect of this drug, when added to the standard drugs used for prophylaxis of GvHD, on reducing the risk of acute GvHD. The drug has also been tested and proven to be very safe in humans.\n\nWhat is the rationale of this trial? As has been described earlier, GvHD is a difficult complication of allogeneic stem cell transplant which can lead to increased hospital stay and deaths post-transplant. The standard drugs for prevention of GvHD are cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cyclophosphamide. These drugs also have some side effects during the course of transplant. This points out the need for new preventive drugs that are safe and effective.\n\nSWA is an oral formulation of WA which seems to be beneficial in the early studies done in the Clinical Pharmacology Laboratory, ACTREC. SWA has also been found to be safe at very high doses.\n\nSWA will be given along with the standard drugs given to prevent GvHD. Despite of consuming these drugs, about 40 - 60% patients still develop GvHD. The investigators aim to add SWA to these standard drugs during transplant to reduce significant aGvHD.\n\nHow will SWA be given? Participants who agree to participate in this trial and are found to be eligible will be given SWA as a capsule at a dose of 500 mg\u002Fday (2 capsules of 250 mg) to 3000 mg\u002Fday (6 capsules of 250 mg) as per the dose level allotted to the Patient. The drug will be given for a total duration 90 days starting from Day +1 of transplant. All other standard treatments which are part of a transplant procedure will be carried out without any change.\n\nParticipants will be monitored clinically for any adverse events and followed up as per standard protocols post-transplant.\n\nWhat additional tests will be carried out? Additional blood sampling to study the levels of the drug WA blood samples will be collected at 0, 1, 2, 4, 8 hours on the day of start of SWA (Day +1) and Day +7. Checking immune cell profile and cytokines (which are markers of - immunity levels) will be done at Day+30, Day +90, Day+180, Day+365 from the start of SWA which is also the part of routine care. Blood sample of 5 ml will also be taken at Day 0, Day +14, Day +30, Day +60 and Day +90 after start of drug to see level of some special protein called JAK2 STAT3 protein.\n\nWhat are the risks involved in participation? According to available literature and information, SWA is a safe and well tolerated drug. In a phase 1 study, Standardized Withaferin-A was administered to Patients with advanced stage osteosarcoma. The drug was well tolerated by Patient up to a dose of 4800 mg. No severe side effects were observed. Increase in liver enzymes and skin rash were the most common side effects. Other side effects included fatigue, fever, swelling, and diarrhea.\n\nWhat is the possible impact of this trial? If indeed SWA works and prevents GvHD effectively then this could be a breakthrough in treatment. It would help many Pateints to prevent GvHD post allogeneic stem cell transplant and would be a safe, easily available, inexpensive and oral drug for the same. This possibly could benefit and help future Patients who undergo bone marrow transplant (BMT) to have better chances of survival and reduce their financial burden.",[30,83,84],"GVHD - Graft-Versus-Host Disease","Hematological Malignancy",[86,87],"Standardized Withaferin A","Matched related donor Hematopoietic stem cell transplant","2026-07-20",{"date":90,"type":38},"2026-07-24",{"date":92,"type":38},"2025-01-28",{"date":94,"type":20},"2029-12-03",{"name":96,"class":45},"Tata Memorial Centre",2,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":5},"100570457","phase-2-ivosidenib-as-post-hsct-maintenance-for-aml-100570457","NCT06707493","Ivosidenib as Post-HSCT Maintenance for AML","A Randomized, Placebo-Controlled Phase 2 Study of IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Acute Myeloid Leukemia Following Allogeneic Stem Cell Transplantation","Inclusion Criteria:\n\n* Pathologically confirmed diagnosis of IDH1(R132)-mutant acute myeloid leukemia (AML). IDH1 mutations could have been detected by any mutational technique at any prior point including at diagnosis or remission.\n* Between the ages of 18 and 75 years\n* Will undergo allogeneic hematopoietic stem cell transplantation (HSCT) for their malignancy. Conditioning may be either conventional myeloablative (MAC) or reduced intensity conditioning (RIC). There will be no restrictions on type of graft source.\n* ECOG performance status ≤ 2\n* Participants must have normal organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1000\u002FµL without growth factor support (e.g. GCSF) in the previous 7 days.\n  * Platelet count ≥ 50,000\u002FµL without transfusional support in the previous 7 days.\n  * AST (SGOT), ALT (SGPT) and Alkaline phosphatase \\\u003C 3x institutional upper limit of normal (ULN)\n  * Direct bilirubin \\\u003C 2.0 mg\u002FdL\n  * Calculated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula)\n* LVEF must be equal to or greater than 40%, as measured by MUGA scan or echocardiogram\n* Female patients of childbearing potential must have a negative pregnancy test\n* The effects of ivosidenib on the developing human fetus are unknown. For this reason female participants of child-bearing potential and male participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 90 days after the last dose of treatment\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior allogeneic hematopoietic stem cell transplants.\n* Morphologically relapsed or refractory disease, as assessed by bone marrow aspirate and biopsy performed within 42 days prior to study entry\n* History of other malignancy(ies) unless\n\n  * the participant has been disease-free for at least 5 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or\n  * the only prior malignancy was cervical cancer in situ and\u002For basal cell or squamous cell carcinoma of the skin\n* Known diagnosis of active hepatitis B or hepatitis C\n* Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \\\u003C 40%, as measured by MUGA scan or echocardiogram)\n* Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome\n* QTc interval (i.e., Friderica's correction \\[QTcF\\]) ≥ 450 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.\n\nPost-transplantation Pre-Treatment Criteria Treatment may begin at any time between day 45 and day 90 following stem cell transplantation.\n\nHowever, at time of treatment start, it must be ensured that:\n\n* The patient has continued willingness and interest in participating in the study.\n* There is no systemic infection requiring IV antibiotic therapy within 7 days preceding the first dose of study drug, or other severe infection\n* Chimerism studies reveal that ≥ 70% of blood or bone marrow cells, or of the CD33 expressing fraction, are of donor origin,\n* There is no acute graft versus host disease (GVHD), requiring an equivalent dose of ≥ 0.5mg\u002Fkg\u002Fday of prednisone within one week of starting ivosidenib \u002F placebo, or have escalation of systemic immunosuppression in terms of increase of corticosteroids or addition of new agent\u002Fmodality within two weeks of starting ivosidenib \u002F placebo.\n* For prophylaxis for GVHD, agents that are permitted for administration on study:\n\n  * Tacrolimus\n  * Cyclosporine\n  * Sirolimus\n  * Cyclophosphamide\n  * Mycophenolate Mofetil\n  * Methotrexate\n  * ATG\n  * Ruxolitinib\n  * Vedolizumab\n  * As standards of care may change, any other prophylactic agents used should be discussed with the PI.\n* Investigational agents, defined as not approved for any indication, are forbidden unless the participant comes off study.\n\n  * Agents used to treat GVHD that are permitted for administration on study:\n  * Any agent used in prophylaxis may be continued (see list above)\n\n    * Ruxolitinib\n    * Etanarcept\n    * ATG\n    * Belumosidil\n    * Axatilimab\n    * Rituximab\n    * Fecal microbiota transplantation\n    * Alpha1-Antitrypsin\n    * Pregnyl\n    * Extracorporal photopheresis (ECP)\n  * As standards of care may change, any other treatment agents used should be discussed with the PI.\n  * Investigational agents, defined as not approved for any indication, are forbidden unless the participant comes off study.\n* There is no evidence of relapsed\u002Frecurrent\u002Fresidual disease.\n* Prior to the start of ivosidenib \u002F placebo administration, the participant must have adequate hematological function, defined as:\n\n  * ANC ≥ 1000\u002FµL\n  * Platelets ≥ 50,000\u002FµL\n\nand adequate organ function defined as\n\n* Direct bilirubin level \\\u003C 2.0 mg\u002FdL\n* AST (SGOT), ALT (SGPT) and Alkaline phosphatase \\\u003C 3x institutional upper limit of normal (ULN)\n* No presence of congestive heart failure, defined by New York Heart Association (NHYA) criteria as class 3 or 4\n* Calculated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula)","75 Years",{"count":107,"type":20},75,[23],"This is a Phase 2 study of the study drug, ivosidenib (a mutant IDH1 inhibitor), compared to placebo, given to patients with IDH1-mutant acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HCT).",[111,112,30],"IDH1 Mutation","Acute Myeloid Leukemia (AML)",[114,115],"hematopoietic stem cell transplantation (HCT)","IDH1-mutant acute myeloid leukemia (AML)","2026-06-17",{"date":118,"type":38},"2026-06-18",{"date":120,"type":38},"2026-01-16",{"date":122,"type":20},"2030-01-01",{"name":124,"class":45},"Massachusetts General Hospital",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100370061","transpire-lung-injury-in-a-longitudinal-cohort-of-pediatric-hsct-patients-100370061","NCT04098445","TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients","Inclusion Criteria:\n\n* Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.\n\nExclusion Criteria:\n\n* Subjects over 24 years of age.","24 Years",{"count":133,"type":20},2000,"OBSERVATIONAL","Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited.\n\nThis is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.",[30,137,138,139,140],"Diffuse Alveolar Hemorrhage","Thrombotic Microangiopathies","Interstitial Pneumonitis","Bronchiolitis Obliterans",{"date":142,"type":38},"2026-06-22",{"date":144,"type":38},"2021-09-08",{"date":146,"type":20},"2033-09",{"name":148,"class":45},"Children's Hospital Medical Center, Cincinnati",9,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":157,"targetDuration":159,"studyType":134,"phases":4,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":97},"100570043","outcome-of-allogeneic-hematopoietic-stem-cell-transplantation-100570043","NCT06702111","Outcome of Allogeneic Hematopoietic Stem Cell Transplantation","Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in Adults: Clinical Outcome and Complications","Inclusion Criteria:\n\n* Adult patients aged 18 years or older who received allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nExclusion Criteria:\n\n* participant who is unable to give informed consent in a prospective cohort.",{"count":158,"type":20},1000,"10 Years","To collect baseline and outcome data relating to all bone marrow, peripheral blood, cord blood hematopoietic stem cell transplants and therapies related to hematopoietic stem cell transplantation performed in Queen Mary Hospital.",[30],[163,164,165],"Hematopoietic stem cell transplantation","Prognostic factors","Outcome","2024-11-25",{"date":168,"type":38},"2024-11-27",{"date":170,"type":20},"2024-12",{"date":172,"type":20},"2030-12",{"name":174,"class":45},"The University of Hong Kong"]