[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hematopoietic-stem-cell-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hematopoietic-stem-cell-transplantation":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,43,76,100,131,156,181,202,228,261,285,307,341,366,389,410,435,461,489,509,539,559,579,603,627],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100285792","long-term-follow-up-of-patients-undergoing-hematopoietic-stem-cell-transplantation-cellular-therapy-or-gene-therapy-100285792",false,"NCT03000244","Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell Transplantation, Cellular Therapy, or Gene Therapy","* INCLUSION CRITERIA FOR PATIENT SUBJECTS:\n* Individuals who underwent HCT or received cellular or gene therapy for any indication (malignant or non-malignant) and are surviving one year or more from the date of therapy\n* Age \\>= 4 years\n* Ability of individual or individual s Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document\n* Individuals will need to have a primary physician within the US (primary care, oncologist, hematologist, etc.) that will provide continued comprehensive care for the duration of participation in the study. PI may allow for established medical providers to be located outside of the US.\n\nEXCLUSION CRITERIA FOR PATIENT SUBJECTS:\n\n-Individuals with active disease relapse or new hematologic malignancy including post-transplant lymphoproliferative disorder (PTLD) are excluded from protocol enrollment.\n\nINCLUSION CRITERIA FOR DONOR SUBJECTS:\n\n* Related stem cell donors of patients meeting the above criteria as a donor of hematopoietic progenitor and stem cells or leukocytes\n* Age \\>= 4years\n* Ability of patient or patient s Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document\n\nINCLUSION CRITERIA FOR PARENTS COMPLETING SURVEYS:\n\n* Parents\u002Fguardians of minors enrolled on the study who have undergone HCT\n* Willingness to complete surveys about the minor that underwent HCT",true,"ALL","4 Years",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","Background:\n\nPeople who have had an allogeneic hematopoietic stem cell transplant (HCT) have bone marrow or an immune system that is damaged. They get stem cells from a donor who is a relative. Researchers want to study stem cell donors and recipients to learn about the long-term effects of HCT. They want to learn how the stem cells change and how to improve their ability to fight cancer.\n\nObjective:\n\nTo provide long-term follow-up care for people who underwent or will undergo HCT. To collect data, blood, and tissue samples to learn about late complications after HCT.\n\nEligibility:\n\nAdults age 18 and older who will undergo HCT or underwent HCT and are surviving one year or more from the date of HCT. The stem cell donors for these recipients are also needed.\n\nDesign:\n\nRecipients will have 1 visit each year. They will have a physical exam. They will answer questions about their medical history and health. They will receive screening and surveillance testing. They will complete brief questionnaires.\n\nRecipients will have blood tests. They may have tissue biopsies or specimens (such as tissue in their cheek or skin or bone marrow biopsy).\n\nRecipients will give their current address and phone number, and the same data for one or two other people, who can get in contact with them.\n\nAfter the first visit at the clinic, some recipients may see a doctor close to home to get the necessary information and send it to NIH.\n\nDonors will come to the clinic for 1 visit. They will answer questions about their medical history. Blood samples will be taken.",[25,26],"Hematopoietic Stem Cell Transplantation","Tissue Donors",[28,29],"Natural History","HCT","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2017-04-26",{"date":38,"type":21},"2050-08-12",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":42},"100645190","immersive-virtual-reality-applied-to-therapeutic-physical-exercise-in-cellular-therapy-100645190","NCT07679958","Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy","RVI-ET","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Signed informed consent.\n* Patients eligible for CT scan at the Alvaro Cunqueiro Hospital.\n* Patients capable of performing therapeutic exercise independently, based on an objective initial functional assessment.\n* The clinical investigator, in their professional judgment, determines that the patient can adhere to all study requirements.\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Any medical condition or mental illness that could interfere with understanding HIP and CI.\n* Patients participating in another clinical trial.\n* Balance disorders that increase the risk of falls.\n* Severe visual and\u002For auditory impairments that prevent participation in the session.\n* History of vertigo, seizures, or epileptic fits.","18 Years",{"count":52,"type":21},144,"INTERVENTIONAL",[55],"NA","Cell therapy (CT), including hematopoietic stem cell transplantation (HSCT) and advanced CAR T-cell therapies, is used for the treatment of oncohematological and other diseases. HSCT is associated with treatment-related toxicities, including fatigue, muscle weakness, and reduced functional capacity due to intensive conditioning chemotherapy, immunosuppressive treatments, corticosteroids, and complications such as infections or graft-versus-host disease. Emotional symptoms, including anxiety, depression, fear, and frustration, also affect patients' recovery and ability to regain functional independence. Evidence indicates that exercise interventions improve emotional well-being, fatigue, quality of life, physical function, cardiovascular fitness, and muscle mass in patients with hematological malignancies and HSCT recipients.\n\nVirtual reality (VR) has emerged as an innovative tool in rehabilitation, supporting patient motivation, exercise guidance, and monitoring. Immersive virtual reality (IVR), through head-mounted displays and multisensory environments, enhances the sense of presence and engagement. Studies suggest that IVR-based exercise programs are feasible, improving functional abilities, quality of life, satisfaction, and adherence.\n\nSince 2017, a Therapeutic Exercise program for patients admitted for HSCT has been implemented at Álvaro Cunqueiro Hospital (Vigo) through collaboration between the Physiotherapy Unit and the Hematology Department. Before admission, patients undergo a physical assessment, receive an individualized exercise plan, education, and a therapeutic exercise guide. Based on clinical experience, the team hypothesizes that integrating IVR into therapeutic exercise may improve motivation, adherence, and emotional well-being during hospitalization.",[58,25,59,60,61],"Hematologic Diseases","Cellular Therapy","Quality of Life","Oncologic Disorders",[63,64,65],"Therapeutic Exercise","Immersive virtual reality","Cellular therapy","NOT_YET_RECRUITING","2026-06-25",{"date":33,"type":34},{"date":70,"type":21},"2026-07-24",{"date":72,"type":21},"2029-06-01",{"name":74,"class":75},"Fundacin Biomedica Galicia Sur","OTHER",{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":53,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":42},"100642285","phase-4-individualized-application-of-anti-thymocyte-globulinatgin-unrelated-donor-hematopoietic-stem-cell-transplantation-100642285","NCT07648992","Individualized Application of Anti-Thymocyte Globulin(ATG)in Unrelated Donor Hematopoietic Stem Cell Transplantation","Application of Anti-Thymocyte Globulin(ATG) Individualized Dosing Model in Unrelated Donor Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Patients with indications for allogeneic hematopoietic stem cell transplantation, with malignant hematologic diseases in CR1 or CR2 before transplantation.\n2. Have an HLA-matched sibling, unrelated, or haploidentical donor.\n3. Age ≥ 14 years and ≤ 65 years.\n4. Liver function: ALT and AST ≤ 2.5 × upper limit of normal, bilirubin ≤ 2 × upper limit of normal.\n5. Renal function: creatinine ≤ upper limit of normal.\n6. No uncontrolled infection or severe mental or psychological disorders.\n7. ECOG performance status score of 0-2.\n8. Signed informed consent.\n\nExclusion Criteria:\n\n\\- 1.No HLA-matched donor. 2.Malignant hematologic disease in CR3 or higher disease stage, or refractory\u002Frelapsed status.\n\n3.Patient age \\\u003C 14 years or \\> 65 years. 4.Pregnancy of either the donor or the recipient. 5.Presence of mental illness or other conditions that preclude compliance with the protocol.","14 Years","65 Years",{"count":86,"type":21},324,[88],"PHASE4","This study aims to compare individualized anti-thymocyte globulin (ATG) dosing versus conventional fixed-dose regimens in unrelated donor peripheral blood stem cell transplantation (URD-PBSCT).\n\nThis study notes that URD-HSCT is a key treatment for malignant hematologic diseases and severe bone marrow failure, with rapid expansion in China. However, this study identifies post-transplant CMV infection as a major challenge, adversely affecting survival and quality of life. This study finds that CMV infection compromises immunity and causes multi-organ complications. Given the high costs, long treatment cycles, and limited efficacy of current interventions, this study considers optimizing CMV prevention to be of greater value than expanding treatment options. This study asserts that effective prevention can reduce infection rates and improve overall survival (OS) and long-term prognosis.\n\nThis study recognizes that ATG is widely used in URD-HSCT to prevent graft-versus-host disease (GVHD), but its dosage is significantly linked to CMV risk. This study indicates that inadequate ATG exposure increases GVHD risk, while excessive exposure raises viral reactivation (e.g., CMV, EBV) and may cause relapse. This study thus identifies balancing GVHD prevention and infection control as a key clinical goal. This study cites Remberger et al. (2004), who compared ATG doses (4-10 mg\u002Fkg) in 162 URD-HSCT patients, finding lower doses increased acute GVHD (aGVHD) and 10 mg\u002Fkg raised infection-related mortality, suggesting 6-8 mg\u002Fkg as a balanced range. This study also references Bacigalupo et al. (2001), who found no survival differences across doses but noted higher doses reduced severe aGVHD at the cost of increased infection. Therefore, this study concludes that optimal ATG dosing requires balancing GVHD, infection, and relapse.\n\nThis study acknowledges that ATG pharmacokinetics (PK) are complex, influenced by dose, body weight, and absolute lymphocyte count (ALC). This study points out that even with fixed dosing, internal exposure (active ATG-AUC) varies greatly among individuals, indicating that fixed dosing is suboptimal and individualized strategies are needed. This study notes that Admiraal et al. developed an ALC-based individualized ATG model, improving immune reconstitution, reducing viral infections, and enhancing OS. However, this study observes that this model was designed for non-myeloablative conditioning and is not applicable to myeloablative conditioning (MAC), which is standard in China.\n\nTo address this, this study states that our team initiated ATG PK studies in 2019. This study explains that under MAC, ALC is nearly eliminated, making traditional models unsuitable. By monitoring active ATG-AUC in 106 haploidentical HSCT (haplo-HSCT) patients and using machine learning, this study identified an optimal exposure window of 100-148.5 UE·day\u002FmL. This study found that patients within this window had lower CMV\u002FEBV reactivation without increased GVHD. This study developed a protocol adjusting doses on days -3 and -2 based on ATG concentrations measured on days -5 and -4. This study confirmed through a prospective single-arm study in haplo-HSCT that this regimen reduces CMV\u002FEBV infection and improves disease-free survival (DFS) and OS while maintaining GVHD control.\n\nGiven the consistency between URD-PBSCT and haplo-PBSCT in conditioning, GVHD prophylaxis, and CMV prevention-and that CMV infection rates in Chinese URD-PBSCT patients reach 65%-70%-this study extends the individualized ATG protocol to URD-PBSCT to validate its universality across donor sources.\n\nIn summary, building on prior haploidentical transplant research, this study applies individualized ATG dosing to URD-PBSCT. This study aims to precisely regulate ATG exposure to reduce CMV infection while maintaining GVHD prophylaxis. This study seeks to improve patient survival and outcomes, laying the foundation for a population PK model and advancing HSCT toward precision medicine.",[25],"2026-06-11",{"date":93,"type":34},"2026-06-15",{"date":95,"type":34},"2025-12-01",{"date":97,"type":21},"2029-12-30",{"name":99,"class":75},"Daihong Liu",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":16,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":53,"phases":111,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100472787","phase-1-the-lowest-effective-dose-of-post-transplantation-cyclophosphamide-in-combination-with-sirolimus-and-mycophenolate-mofetil-as-graft-versus-host-disease-prophylaxis-after-reduced-intensity-conditioning-and-peripheral-blood-stem-cell-transplantation-100472787","NCT05436418","The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation","Phase I\u002FII Trial to Determine the Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation","* INCLUSION CRITERIA:\n\nRecipient\n\n* Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation limited to one of the following:\n\n  * Acute myeloid leukemia (AML) of intermediate or adverse risk disease by the 2017 European LeukemiaNet criteria in first morphologic complete remission (\\\u003C5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)\n  * AML of any risk in second or subsequent morphologic complete remission\n  * Acute lymphoblastic leukemia in first or subsequent complete remission\n  * Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)\n  * Primary myelofibrosis of intermediate-2 or higher risk by the DIPSS\n  * Chronic myelomonocytic leukemia\n  * Chronic myelogenous leukemia resistant to or intolerant of \\>= 3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis\n  * B-cell lymphoma including Hodgkin lymphoma that has relapsed within 1 year of completion of primary treatment, relapsed after autologous transplantation, or has progressed through at least 2 lines of therapy\n  * Chronic lymphocytic leukemia with 17p deletion and\u002For unmutated IgHV or refractory to or intolerant of both BTK and PI3K inhibitors\n  * Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on the Prognostic Index for T-cell lymphoma (PIT) score of low-intermediate risk or higher or on recently published clinical practice guidelines\n  * Hematologic malignancy of dendritic cell or histiocytic cell type\n  * Multiple myeloma, stage III, relapsing after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD)\n* Age \\>= 50 years or age 18-49 years and also meeting one of the following criteria:\n\n  * Prior myeloablative HCT\n  * Prior exposure to inotuzumab, gemtuzumab, or other agent that increases the risk for sinusoidal obstruction syndrome.\n  * Hematopoietic Cell Transplantation- Comorbidity Index (HCT-CI) \\>= 3\n  * Karnofsky performance score \\\u003C80\n  * Co-morbidity considered by the treating physician to be exclusionary of myeloablative conditioning\n* At least one potentially suitable HLA-haploidentical or 10\u002F10 (HLA-A, B, C, DR, DQ) related or unrelated donor for HCT\n* Karnofsky performance score \\>= 70\n* Adequate organ function defined as possessing all of the following:\n\n  * Cardiac ejection fraction \\>= 45% by 2D ECHO;\n  * Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of \\>= 50% predicted;\n  * Estimated serum creatinine clearance of \\>= 60 ml\u002Fminute\u002F1.73m\\^2 calculated using eGFR in the clinical lab;\n  * Total bilirubin \\\u003C= 2X the upper limit of normal;\n  * Alanine aminotransferase and aspartate aminotransferase \\\u003C= 3X the upper limit of normal.\n* Individuals of child-bearing potential (IOCBP) and participants who can father children must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one year post-transplant.\n* IOCBP must have a negative serum or urine pregnancy test within 7 days prior to initiation of conditioning regimen.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nRecipient\n\n* Participants who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning.\n* Active nursing.\n* Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is: metastatic, or relapsed\u002Frefractory to treatment, or locally advanced and not amenable to curative treatment, or limited disease treated with curative intent treatment within the last 2 years. This excludes non-melanoma skin cancers.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents.\n* Uncontrolled intercurrent illness (e.g., severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active infectious hepatitis, uncontrolled dental infection) that in the opinion of the Site PI would make it unsafe to proceed with transplantation.\n\nINCLUSION CRITERIA:\n\nDonor\n\n* Related (age \\>=12) and unrelated (age \\>=18) donors deemed eligible (i.e., evaluated at NIH, COH, and FHCC in accordance with existing institutional Standard Policies and Procedures or evaluated per the standards required by the IRB of the National Marrow Donor Program or applicable registry), and willing to donate research samples will be included.\n* Ability of participant or parent\u002Flegal guardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nDonor\n\nNone","12 Years","120 Years",{"count":110,"type":21},260,[112,113],"PHASE1","PHASE2","Background:\n\nBlood cancers (such as leukemias or lymphomas) often do not respond to standard treatments. A transplant of blood stem cells from a healthy donor can help people with these cancers. Sometimes these transplants cause serious side effects, including a common immunologic problem called graft-versus-host disease. A drug called cyclophosphamide given early after the transplant (post-transplantation cyclophosphamide, PTCy) can reduce these complications. But sometimes this drug has its own negative effects. Furthermore, studies in mice suggest that an intermediate, rather than very high, dose of this drug may best protect against graft-versus-host disease.\n\nObjective:\n\nTo find out if a lower dose of PTCy is more helpful for people who undergo blood stem cell transplants.\n\nEligibility:\n\nPeople aged 18 and older who have a blood cancer and are eligible for a transplant of blood stem cells from another person. Healthy donors are also needed but must be related to the individual needing the transplant.\n\nDesign:\n\nParticipants will undergo screening. Transplant recipients will have imaging scans and tests of their heart and lung function. They will be assessed for the status of their cancer, including bone marrow taken from their pelvis and possibly also scans and\u002For fluid drawn from the spine depending on the disease type.\n\nDonors will be screened for general health. They will give several tubes of blood. They will give an oral swab and saliva and stool samples for research.\n\nRecipients will be in the hospital at least 4 to 6 weeks.\n\nThey will have a temporary catheter inserted into a vein in the chest or neck. Medications will be given and blood will be drawn through the catheter.\n\nThe transplanted stem cells will be given through the catheter. Participants will receive medications both before and after the transplant.\n\nParticipants will return to the clinic at least once a week for 3 months after leaving the hospital. Follow-up visits will continue periodically for 5 years.",[116,25],"Peripheral Blood Stem Cell Transplantation",[118,119,120,121,122],"Reduced Intensity Conditioning","Systemic Immunosuppressive Therapy","Hematologic Malignancy","Acute Myeloid Leukemia","Calcineurin Inhibitor","2026-06-10",{"date":91,"type":34},{"date":126,"type":34},"2022-11-18",{"date":128,"type":21},"2028-06-25",{"name":40,"class":41},2,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":16,"sex":17,"minAge":50,"maxAge":108,"enrollmentInfo":137,"targetDuration":4,"studyType":53,"phases":139,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":130},"100485784","longitudinal-early-advance-care-planning-discussions-and-documentation-leadd-program-an-exploratory-study-in-adolescents-and-young-adults-ayas-receiving-hematopoietic-stem-cell-transplant-100485784","NCT05605574","Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant","* INCLUSION CRITERIA:\n* AYA Participants:\n\n  * Age \\>= 18 to \\\u003C= 39 years.\n  * Planned allogeneic HSCT at a participating site.\n  * Participants must be English speaking.\n  * Ability to understand and the willingness to sign a written informed consent document.\n* Caregiver Participants:\n\n  * Age: \\>= 18 years.\n  * Identified as caregiver by participating AYA participant. Only a single caregiver will be allowed to participate.\n  * Physically present at the participating site.\n  * Participants must be English speaking.\n  * Ability to understand and the willingness to sign a written informed consent document.\n* Provider participants:\n\nHealthcare providers at the participating site who are part of the AYA participant's HSCT team and provided direct clinical care to AYA participants during period of study enrollment between completion of conversation #1 and conversation #3.\n\nEXCLUSION CRITERIA:\n\nNone.",{"count":138,"type":21},222,[55],"Background:\n\nFor adolescent and young adults (AYAs) with certain life-threatening illnesses, hematopoietic stem cell transplant (HSCT) provides the best chance for cure and survival. HSCT is a life-saving therapy, but this treatment also comes with significant risks. Given these risks, it is imperative that patients and their families have the opportunity to share their values, priorities, and goals through advance care planning (ACP) to ensure that the care they receive through the transplant process remains patient-centered. Despite the benefits of ACP discussions, many barriers, including provider discomfort, may prevent these conversations with AYAs.\n\nObjective:\n\nTo see if AYAs who undergo HSCT and their caregivers benefit from discussing ACP topics.\n\nEligibility:\n\nPeople aged 18 to 39 years enrolled in an NIH study with a planned HSCT. One caregiver aged 18 years or older will also be invited to participate.\n\nDesign:\n\nParticipants will complete a 20-minute questionnaire. They will be asked about the priorities they have related to their care and their prior experiences with ACP.\n\nParticipants will have 3 conversations with a study team member over 4 to 9 weeks. Each talk will last 45 to 60 minutes.\n\nFirst, participants will talk about their upcoming transplant and their expectations. They will also be asked about their fears and worries and will discuss what is most important to them in terms of support, comfort, their values, and their goals.\n\nNext, they will learn about Voicing My CHOiCES . This guide gives people a place to say what kind of care they want to receive during their treatment and includes a place to document how they would want to be cared for if they can no longer make decisions on their own. Participants will be guided as they fill in a few pages from this guide.\n\nThe third conversation will review the first talks. Participants may ask questions and review any topic. They will complete follow-up questionnaires and be provided with a summary of their care priorities revealed in the discussions. They will be asked about their experience participating in this study, and their comfort with ACP discussions. They will be asked what they think of the meaningfulness, timing, and cultural sensitivity of these talks....",[25],[143,144,145,146,147],"Communication","Goals Of Care","Voicing My Choices","Palliative Care","Psychosocial","2026-06-04",{"date":150,"type":34},"2026-06-05",{"date":152,"type":34},"2022-11-16",{"date":154,"type":21},"2026-12-31",{"name":40,"class":41},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":53,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100636743","phase-4-letermovir-prophylaxis-duration-guided-by-cmv-specific-t-cell-monitoring-after-allo-hsct-100636743","NCT07569653","Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.","A Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Letermovir Prophylaxis Duration Guided by Dynamic Monitoring of Specific T-cells for Preventing Cytomegalovirus Infection in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplantation in China.","Inclusion Criteria:\n\n1. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n2. CMV serostatus of the recipient is positive (R+).\n3. Aged 18 years or older.\n4. Expected survival \\> 6 months.\n5. Provision of signed informed consent.\n\nExclusion Criteria:\n\n* 1.Active CMV infection or CMV disease at the time of screening.\n\n  2.Known hypersensitivity to Letermovir or its excipients.\n\n  3.Severe hepatic or renal impairment.\n\n  4.Pregnant or breastfeeding women.",{"count":164,"type":21},120,[88],"The purpose of this study is to evaluate the efficacy and safety of a personalized strategy for discontinuing Letermovir (a drug used to prevent Cytomegalovirus \\[CMV\\] infection) based on the recovery of the patient's own immune system.\n\nCytomegalovirus (CMV) is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, Letermovir is typically given as a standard prevention for about 100 days post-transplant. However, some patients may recover their CMV-specific immunity earlier, while others may need longer protection.\n\nIn this study, researchers will use a dynamic monitoring technology (QuantiFERON-CMV) to detect the level of CMV-specific T-cells in patients. Participants will be randomly assigned to either the experimental group or the control group:\n\nExperimental Group: Letermovir discontinuation will be guided by T-cell recovery. If the test shows that the patient's CMV-specific T-cells have recovered, Letermovir may be stopped earlier than the standard 100 days.\n\nControl Group: Patients will receive the standard Letermovir prophylaxis for approximately 100 days, regardless of T-cell status.\n\nThe study aims to determine if this immune-guided strategy can effectively prevent CMV infection while potentially reducing the duration of medication and associated costs, without increasing the risk of CMV disease.",[168,169,25,170],"Cytomegalovirus Infections","Cytomegalovirus Disease","Graft vs Host Disease","2026-05-27",{"date":173,"type":34},"2026-06-01",{"date":175,"type":34},"2025-10-30",{"date":177,"type":21},"2027-12",{"name":179,"class":75},"WeiShi",12,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":53,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100638654","phase-2-xiaochaihu-granules-for-depression-after-allogeneic-hematopoietic-stem-cell-transplantation-100638654","NCT07608029","Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell Transplantation","A Single-Center, Prospective, Randomized, Parallel-Assignment, Phase II Study Evaluating Two Dose Levels of Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Able to understand the study procedures and voluntarily provide written informed consent (or consent from a legal guardian where applicable);\n  2. Age ≥14 years, male or female;\n  3. Patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n  4. Newly diagnosed depression after allo-HSCT, assessed by standardized scales (e.g., HADS and\u002For HAMD);\n  5. Evidence of successful neutrophil engraftment prior to enrollment;\n  6. Willing and able to comply with study procedures and follow-up assessments.\n\nExclusion Criteria:\n\n1. Refusal to participate in the study;\n2. Presence of severe psychiatric disorders or severe somatic symptom disorders;\n3. Known allergy to Xiaochaihu Granules or any of its components;\n4. Current use of other antidepressant medications;\n5. Severe organ dysfunction or unstable clinical condition, including but not limited to:\n\n   Uncontrolled bloodstream infection; Expected survival \\\u003C3 months;\n6. History of splenectomy;\n7. Renal insufficiency with serum creatinine ≥2.0 mg\u002FdL;\n8. Cholestatic liver disease or unresolved hepatic veno-occlusive disease (VOD);\n9. Significant cardiovascular conditions, including:\n\n   Unstable angina; Acute myocardial infarction within 6 months prior to enrollment; NYHA class III-IV heart failure; Circulatory failure requiring vasoactive or inotropic support; Clinically significant arrhythmia requiring treatment;\n10. Severe respiratory disease requiring mechanical ventilation or ≥50% oxygen support;\n11. Patients whose primary disease is in complete remission after transplantation (per protocol definition);\n12. Participation in another interventional clinical trial within 21 days prior to enrollment (or within 5 half-lives of the investigational product, whichever is longer);\n13. Any other condition deemed by the investigator to make the patient unsuitable for participation.",{"count":189,"type":21},46,[113],"This is a single-center, prospective, randomized, dose-escalation Phase II clinical study. A total of 46 patients with newly diagnosed depression following allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be enrolled.\n\nParticipants will be randomly assigned to receive different doses of Xiaochaihu Granules in addition to standard post-transplant care for 100 days. The primary objective is to evaluate the efficacy of Xiaochaihu Granules in improving depressive symptoms. Secondary objectives include assessment of safety and clinical outcomes such as event-free survival (EFS), graft-versus-host disease (GVHD), infections, and other transplantation-related complications.",[193,25],"Depressive Disorder, Secondary","2026-05-25",{"date":171,"type":34},{"date":197,"type":21},"2026-05-16",{"date":199,"type":21},"2029-09-30",{"name":201,"class":75},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":53,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":227,"locationsCount":42},"100441406","phase-2-a-phase-ii-study-of-allogeneic-hematopoietic-stem-cell-transplant-for-subjects-with-vexas-vacuoles-e1-enzyme-x-linked-autoinflammatory-somatic-syndrome-100441406","NCT05027945","A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Subjects With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) Syndrome","* INCLUSION CRITERIA:\n\nNon-disease related\n\n* Age \\>= 18-year-old and \\\u003C= 75-year-old\n* Availability of an 8\u002F8 or 7\u002F8 HLA-matched related or unrelated donor, or a haploidentical related donor\n* Karnofsky performance status of \\>= 40%\n* Adequate end-organ function, defined as follow:\n\n  1. Left ventricular ejection fraction \\> 35%, preferably by 2-D echocardiogram (ECHO) obtained within 60 days prior to treatment initiation.\n  2. Creatinine \\\u003C= 2.0 mg\u002Fdl and creatinine clearance \\>= 30 ml\u002Fmin;\n  3. Serum conjugated bilirubin \\\u003C 3.0 mg\u002Fdl; serum ALT and AST \\\u003C= 5 times upper limit of normal.\n* Pulmonary function tests: FEV1 and DLCO \\>30%\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* As therapeutic agents used in this trial may be harmful to a fetus, individuals of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) at the study entry and for at least one-year post-allo HCT. Should an individual become pregnant or suspect they are pregnant while she or her partner is participating in the study, she should inform her treating physician immediately.\n* Willingness to remain in the NIH hospital or, if discharged, live within 2 hours drive from the NIH, for a minimum of 100 days after transplant or longer, if there are complications. If outpatient in the first 100 days after transplant, participant must commit to having an adult caregiver with them at all times.\n\nDisease related\n\n* Somatic mutation in UBA1 performed by a CLIA or CAP certified laboratory. NOTE: Participants without a mutation or unknown mutation status may be eligible if they have a clinical history that is characteristic of an individual with VEXAS syndrome including two or more of a-e below.\n* Inflammatory clinical phenotype for VEXAS syndrome with at least one VEXAS disease manifestation below:\n\n  1. constitutional symptoms including fevers, fatigue, and weight loss\n  2. cutaneous symptoms of VEXAS including biopsy proven neutrophilic dermatosis, cutaneous vasculitis, periorbital inflammation\n  3. pulmonary symptoms of VEXAS with pulmonary infiltrates, pleural effusion\n  4. musculoskeletal or cartilaginous involvement including inflammatory arthritis, ear chondritis, and nasal chondritis\n  5. inflammatory disease in other major organ systems including cardiac, gastrointestinal, ocular, etc.\n* Presence of cytopenia defined as at least one of the following:\n\n  i. Absolute neutrophil count \\\u003C=1000\u002F microliter\n\nii. platelet count \\\u003C= 75,000\u002Fmicroliter or platelet transfusion dependence (at least 4 platelet transfusions in the 8 weeks prior to study entry\n\niii. hemoglobin \\\u003C= 10.0g\u002FdL or red cell transfusion-dependence (at least 4 units of PRBCs in the 8 weeks prior to treatment initiation) or meeting criteria for myeloid neoplasm (MN) by updated 2022 WHO criteria or 2022 International Consensus Classification (ICC) of myeloid neoplasms and acute leukemia\n\nOR:\n\n-Participants who have failed standard medical management (requiring \\>= 0.5mg\u002Fkg per day of prednisone for the above listed inflammatory condition or intolerance or refractory to use of corticosteroids and\u002For steroid sparing medications as well as biological response modifiers over the last 6 months), or when no standard medical treatment is available.\n\nEXCLUSION CRITERIA:\n\n* HCT Comorbidity Index \\>= 5. Note: Comorbidities that are specifically addressed in the inclusion criteria will not be included in the calculation of HCT-CI score.\n* Participants with multiple myeloma. Note: participants with low risk smoldering multiple myeloma or monoclonal gammopathy of unknown significance will not be excluded)\n* Participants who are receiving any other investigational agents within the last 30 days before treatment initiation.\n* HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents (steroids, cyclophosphamide, busulfan, tacrolimus, MMF, filgrastim or filgrastim biosimilar) used in the study.\n* Pregnant individuals are excluded from this study because the study agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued if the mother is treated with the study agents.\n* Uncontrolled intercurrent illness or social situations (as determined by a licensed master social worker) that would limit compliance with study requirements.\n* Presence of active uncontrolled infections that in the opinion of the PI would make it unsafe to proceed with transplantation.\n* Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol.","75 Years",{"count":210,"type":21},54,[113],"Background:\n\nAllogeneic hematopoietic stem cell transplant involves taking blood stem cells from a donor and giving them to a recipient. The transplants are used to treat certain diseases and cancers. Researchers want to see if the transplant can treat VEXAS Syndrome.\n\nObjective:\n\nTo see if stem cell transplants can be successfully performed in people with VEXAS and even improve the disease.\n\nEligibility:\n\nPeople ages 18-75 who have VEXAS Syndrome that has caused significant health problems and standard treatment either has not worked or is not available.\n\nDesign:\n\nParticipants will be screened with:\n\nPhysical exam\n\nMedical review\n\nBlood and urine tests\n\nHeart and lung function tests\n\nBone marrow biopsy\n\nParticipants will have a chest x-ray. They will have an imaging scan of the head, chest, abdomen, pelvis, and sinus. They will have a bone density scan. They will have a dental exam and eye exam. They will meet with specialists. They will repeat some screening tests.\n\nParticipants will be admitted to the NIH hospital. They have a central venous catheter put into a vein in the chest or neck. They will receive drugs to prepare their bone marrow for the transplant. They may have total body irradiation. They will receive the donor stem cells through the catheter. They will get other drugs to prevent complications and infections. After discharge, they must stay in the DC area for 3 months for weekly study visits.\n\nParticipants will have study visits 30, 60, 100, 180, 210, 240, 300, and 360 days later. After that, they will have yearly visits for 2 years and then be contacted yearly by phone....",[214,25],"Immunodeficiency",[216,217,218,219,220],"Immune Dysregulation","Haploidentical","hematoinflammatory diseases","Myelodysplastic Syndromes","Autoimmune Disorders","2026-05-07",{"date":223,"type":34},"2026-05-08",{"date":225,"type":34},"2023-02-23",{"date":33,"type":21},{"name":40,"class":41},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":53,"phases":238,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":42},"100639616","hematocare-feasibility-of-a-survivorship-care-plan-for-hematologic-cancer-patients-undergoing-hsct-100639616","NCT07579065","HematoCare: Feasibility of a Survivorship Care Plan for Hematologic Cancer Patients Undergoing HSCT","Survivorship Care in Patients With Hematologic Cancer Undergoing HSCT: A Feasibility Study on Quality of Life, Unmet Needs, and Caregivers Burden","HematoCare","Inclusion Criteria:\n\n* Patients with hematologic cancer candidates for HSCT (autologous or allogeneic) and their informal caregivers\n* Able to provide informed consent\n* Able to communicate in Italian\n\nExclusion Criteria:\n\n* Patients or caregivers with comorbidities hindering participation (e.g., significant cognitive limitations)",{"count":237,"type":21},40,[55],"This is a feasibility study to implement a Survivorship Care (SC) Plan for patients with hematologic cancer undergoing hematopoietic stem cell transplantation (HSCT). The study evaluates if the intervention is feasible within the Italian national health system, focusing on retention rates, quality of life, unmet needs and caregiver burden",[241,25,242,243],"Hematologic Neoplasm","Survivorship","Cancer Survivorship",[245,246,60,247,248,249,250],"Hematologic Malignancies","Survivorship Care","Caregiver Burden","Unmet Needs","Feasibility Study","Patient Reported Outcome Measures (PROMs)","2026-05-06",{"date":253,"type":34},"2026-05-11",{"date":255,"type":21},"2026-06",{"date":257,"type":21},"2028-01",{"name":259,"class":260},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":53,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":4},"100639963","peer-support-intervention-for-caregivers-of-patients-undergoing-hsct-100639963","NCT07577674","Peer Support Intervention for Caregivers of Patients Undergoing HSCT","Peer Support Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation: Feasibility and Preliminary Efficacy Trial","STEPP-Care","Inclusion Criteria:\n\n* Adult caregivers (≥18 years of age) of patients with hematologic malignancies who are undergoing autologous or allogeneic HSCT at Dana-Farber Cancer Institute.\n* Is a relative or friend who is identified by the patient to be their caregiver.\n* Ability to speak, read, and respond in English\n* Has access to a phone.\n\nExclusion Criteria:\n\n* Caregivers with acute or unstable psychiatric conditions or other cognitive conditions that the treating oncologist believes would prohibit informed consent or ability to adhere to study procedures.",{"count":270,"type":21},90,[55],"The main purpose of this study is to determine if a tailored peer support intervention (STEPP-Care) is feasible among caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).",[25],[275,276],"Caregivers","Stem Cell Transplantation","2026-05-04",{"date":253,"type":34},{"date":280,"type":21},"2026-09-30",{"date":282,"type":21},"2031-09-30",{"name":284,"class":75},"Brigham and Women's Hospital",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":16,"sex":17,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":42},"100516372","oral-chemosensory-and-trigeminal-functions-in-allo-hsct-100516372","NCT06003660","Oral, Chemosensory and Trigeminal Functions in Allo-HSCT","Oral, Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study","Inclusion Criteria:\n\n• patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome\n\nExclusion Criteria:\n\n* disorders affecting the oral cavity including poor tooth-status\n* those using drugs affecting the gustatory\u002Folfactory functions\n* those with brain disorders\n* those who have a chronic disorder affecting the immune system, have cancer or who are pregnant.","30 Years","70 Years",{"count":295,"type":21},70,"The goal of this prospective, cohort study is to learn about smell, taste and trigeminal dysfunction in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). The research team hypothesizes that treatment with allo-HSCT will induce:\n\n* Distortion of taste and smell and trigeminal functions like cooling, tingling, and burning sensations.\n* Reduced saliva production leading to oral dryness and dental caries.\n* Changes in the connectivity of the taste-, smell- and pain-cortical brain regions.",[25],"2026-04-27",{"date":300,"type":34},"2026-05-01",{"date":302,"type":34},"2023-08-10",{"date":304,"type":21},"2028-03-01",{"name":306,"class":75},"University of Oslo",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":84,"enrollmentInfo":314,"targetDuration":4,"studyType":53,"phases":316,"briefSummary":317,"conditions":318,"keywords":322,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":42},"100623722","phase-2-amimestrocel-injection-for-preventing-severe-oral-mucositis-in-hsct-patients-100623722","NCT07400328","Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients","A Single-Arm, Single-Center Exploratory Study of Amimestrocel Injection for the Prevention of Gastrointestinal Mucositis Induced by Conditioning Regimens Containing TBI and\u002For Melphalan","Inclusion Criteria:\n\n1. Aged 18 to 65 years.\n2. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplantation.\n3. The conditioning regimen must contain total body irradiation (TBI) and\u002For melphalan.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function defined as:Left ventricular ejection fraction (LVEF) ≥ 50%.Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin.\n6. Voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n1. History of allergy to mesenchymal stem cells or any component of the Amimestrocel injection preparation.\n2. Presence of active, uncontrolled bacterial, fungal, or viral infection.\n3. History of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell skin cancer.\n4. Pregnant or lactating women, or those planning pregnancy during the study period.\n5. Previous receipt of any cell therapy product.\n6. Severe psychiatric disorder or cognitive impairment that would limit the ability to provide informed consent or comply with study procedures.\n7. Any condition that, in the investigator's judgment, makes the subject unsuitable for study participation.",{"count":315,"type":21},22,[113],"This study aims to see if a single intravenous infusion of a cell therapy called Amimestrocel injection can help prevent severe mouth sores (oral mucositis) in patients receiving a stem cell transplant.\n\nPatients getting a stem cell transplant often receive strong chemotherapy (with radiation and\u002For a drug called melphalan) that can cause painful mouth and gut sores, making eating difficult and increasing infection risk. Amimestrocel injection is made from human umbilical cord cells that may help reduce inflammation and promote healing.\n\nAbout 22 adult patients scheduled for this type of transplant at one hospital in China will receive the infusion 1-2 days before their stem cell transplant. Researchers will closely check for mouth sores, pain, and side effects for the first 28 days, and continue safety monitoring for 100 days.\n\nThe main goal is to see if the treatment lowers the rate of severe (Grade 3-4) mouth sores. The study will also track pain levels, need for pain medication, diarrhea, time for blood counts to recover, and overall safety.",[319,320,321,25],"Oral Mucositis","Stomatitis","Gastrointestinal Mucositis",[323,324,325,326,327,328,329,330,331],"Amimestrocel","Mesenchymal Stem Cells","Umbilical Cord","Mucositis Prevention","Total Body Irradiation","Melphalan","Conditioning Regimen","Allogeneic Transplantation","Single-Arm Trial","2026-04-12",{"date":334,"type":34},"2026-04-14",{"date":336,"type":34},"2026-02-15",{"date":338,"type":21},"2028-01-31",{"name":340,"class":75},"The First Affiliated Hospital of Soochow University",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":348,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":42},"100585568","metagenomics-next-generation-sequencing-approach-to-detect-microbial-dnarna-overtime-in-individuals-undergoing-hematopoietic-stem-cell-transplant-100585568","NCT06904053","Metagenomics Next-generation Sequencing Approach to Detect Microbial DNA\u002FRNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant","Metagenomics Next-Generation Sequencing Approach to Detect Microbial DNA\u002FRNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study; an individual must meet all the following criteria:\n\n1. Male or female, aged 3 years or older.\n2. Co-enrolled on another study at the NIH CC, under which they will undergo HSCT.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual with any condition that, in the opinion of the investigator, contraindicates participation in this study, will be excluded.","3 Years","100 Years",{"count":351,"type":21},30,"Infections are a major cause of morbidity and mortality in patients undergoing hematopoietic stem cell transplant (HSCT). The purpose of this study is to evaluate if metagenomic next-generation sequencing (mNGS) can detect microbial signatures in people undergoing HSCT, and if microbial identification can be correlated with clinical features of infection (e.g., fever). Participants undergoing HSCT as part of other studies at the NIH Clinical Center (CC) will provide blood before the transplant and through 6 months after. Total nucleic acid will be extracted from plasma and subjected to mNGS.\n\nThe primary objective of this study is to investigate if by using plasma and an mNGS approach, we can detect bacterial, fungal, protozoan, or viral DNA\u002FRNA over time, in immunocompromised patients undergoing transplantation.\n\nSecondary objectives are to: (1) To correlate microbial identification with episodes of fever or clinical suspicion of infection; and to (2) correlate change in microbial signatures in patients with suspected immune reconstitution inflammatory syndrome.\n\nThe study is conducted at the NIH Clinical Center. Participants, aged 3 years and older, on other research studies at the NIH CC who are undergoing HSCT are invited to take part of this study. Expected participation is up to six months.",[25],[355,356],"Microbial DNA\u002FRNA","Hematopoietic stem cell transplant (HSCT)","2026-04-03",{"date":359,"type":34},"2026-04-06",{"date":361,"type":34},"2025-04-09",{"date":363,"type":21},"2030-12-30",{"name":365,"class":41},"National Institutes of Health Clinical Center (CC)",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":374,"targetDuration":375,"studyType":22,"phases":4,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":4},"100565251","respiratory-microbioma-and-respiratory-complications-after-hematopoietic-stem-cell-transplantion-100565251","NCT06639750","Respiratory Microbioma and Respiratory Complications After Hematopoietic Stem Cell Transplantion","Dynamic Evaluation of Composition and Evolution of Respiratory Viroma\u002FMicrobioma of Patients Who Have Undergone Hematopoiteic Stem Cell Transplantation (HSCT), as a Possible Biomarker of Occurrence of Post-HSCT Pulmonary Complications.","VIREMIG","Inclusion Criteria:\n\n* Male or female, aged 18 or over\n* French-speaking\n* Followed in the centre's haematology department with a project for a haematopoietic stem cell allograft\n* Whatever the haemopathy, previous treatments, type of transplant (pheno, geno, haplo-identical), type of graft (bone marrow, peripheral stem cells, cord blood), any conditioning (myeloablative or non-myeloablative), any immunosuppressive protocol.\n* Be affiliated to the social security system\n* Person able to understand the information and sign the consent form.\n* Informed consent must be collected and signed\n\nExclusion Criteria:\n\n* Refusal to take part in the research\n* Failure to sign the consent form\n* Contraindication to nasopharyngeal swabbing",{"count":164,"type":21},"2 Years","Allogeneic haematopoietic stem cell transplantation (AHSCT) is a therapeutic resource for many haemopathies. The number of HSCTs has risen sharply in recent years due to the use of attenuated conditioning, which has increased the risk of non-haematological complications. Pulmonary pathologies are a frequent cause of complications following HSCA, both infectious and non-infectious(1,3,4).\n\nAmong these, late non-infectious pulmonary complications (LNIPC), all taken together, occur in 25% of post-HSCA cases(1). These NIPCs, the most common of which is bronchiolitis obliterans, significantly alter the prognosis(4,5). The pathophysiology of CPTNI is poorly understood, but it seems that the occurrence of a viral respiratory infection (pre- or post-ACSH) may be a potential trigger for the onset of CPTNI(1). These viral infections can become \"chronic\", given that viral clearance is impaired by the underlying immunodepression, and can thus cause chronic inflammation leading to the fibrosing and irreversible process of obliterative bronchiolitis(6). Given the prognostic importance of this type of CPTNI, it seems essential to gain a better understanding of its pathophysiology, which may involve a number of mechanisms: cellular expression of the graft and its evolution, disruption of the host response (innate immunity) following viral infection, influence of the microbiome and alteration of epithelial repair(1,3,5). Interest in the digestive and respiratory microbiome has been growing in recent years(7-9). The literature is gradually being enriched with data on the links between infection, the microbiome and chronic respiratory pathology and, in the post-HSCA context, a potential link between the enteric microbiome and Chronic Graft Versus Host Disease (cGVHD).\n\nA pilot study comparing respiratory microbiomes using sequencing and metatranscriptomic analysis on 20 respiratory samples (nasopharyngeal swab and bronchoalveolar lavage pairs) taken under the conditions of the proposed study showed that the technique was highly feasible and highly sensitive.\n\nThe aim of this study is therefore to use meta-genomics to investigate the respiratory virome\u002Fmicrobiome in a population of patients who have undergone HSCA: eukaryotic and prokaryotic viruses, bacterial expression and the expression (meta-transcriptomics) of graft-derived cell lines and their possible association with the occurrence of post-HSCA respiratory complications (infectious and non-infectious).\n\nNo study has assessed the link between the composition of the respiratory virome\u002Fmicrobiome and the occurrence of respiratory events (infectious and CPTNI post ACSH), but also more broadly the link with the composition of the microbiome in the broad sense (respiratory virome, respiratory and digestive microbiota).\n\nThe aim of this study is to establish a respiratory viral and bacterial map as a possible biomarker of the occurrence of respiratory events (infectious and CPTNI), thus enabling more personalised monitoring of patients at risk of CPTNI and management of immunosuppressive treatment of patients at risk of an infectious episode, with risk assessment based on the composition of the respiratory virome.\n\nThe interest of this study is that it is multidisciplinary and transdisciplinary, studying the respiratory pathologies and infections of haematology patients and combining clinical and fundamental research, with expected spin-offs for direct patient care (personalised monitoring and management of immunosuppressive treatments).",[25,378,379],"Microbioata","Respiratory Complications","2026-03-17",{"date":382,"type":34},"2026-03-18",{"date":384,"type":21},"2026-04-01",{"date":386,"type":21},"2030-04-01",{"name":388,"class":75},"University Hospital, Caen",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":396,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":42},"100373778","nutritional-status-of-patients-after-hematopoietic-stem-cell-transplantation-100373778","NCT04146870","Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation","A Survey of Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Patients who undergo hematopoietic stem cell transplantation in the First Affiliated Hospital of Soochow University.\n* Having a life expectancy of more than 3 months\n\nExclusion Criteria:\n\n* Not willing to participate in the investigation\n* Age less than 15 years old or more than 80 years old","15 Years","80 Years",{"count":399,"type":21},200,"The main objectives of this study were :(1) to comprehensively and systematically evaluate the nutritional status of patients after hematopoietic stem cell transplantation. (2) to explore the effect of nutritional factors on the prognosis of patients treated by hematopoietic stem cell transplantation.",[402,25],"Nutrition",{"date":404,"type":34},"2026-03-19",{"date":406,"type":34},"2018-10-01",{"date":408,"type":21},"2026-12-30",{"name":340,"class":75},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":83,"maxAge":417,"enrollmentInfo":418,"targetDuration":4,"studyType":53,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":432,"locationsCount":434},"100531339","moxibustion-for-the-prevention-of-hemorrhagic-cystitis-after-allo-hsct-100531339","NCT06198517","Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT","Clinical Study of Moxibustion for the Prevention of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);\n2. Age: 14-60 years;\n3. Patients with pernicious blood diseases undergoing allo-HSCT using the MAC protocol or patients with severe aplastic anemia (Severe aplastic anemia; severeaplasticanimin, SAA) undergoing allo-HSCT;\n\nExclusion Criteria:\n\n1. refuse to participate in this clinical study;\n2. The corresponding skin at the moxibustion site is broken or sensitive;\n3. allo-HSCT pretreated with the RIC program;","60 Years",{"count":419,"type":21},266,[55],"This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-HSCT), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. The control group was treated conventionally, and the experimental group increased moxibustion of Zhongji, Guanyuan and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation. Urine routine tests were performed at the time of admission, +1d, and +14d, and urine BK virus, JC virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of HC, respectively; routine urine tests were performed once every 7 days for all patients within 100days. For patients with Hemorrhagic cystitis (HC), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major TCM evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of HC in this patient population.",[423,25,424,425],"Moxibustion","Hemorrhagic Cystitis","Prevention","2026-03-09",{"date":428,"type":34},"2026-03-12",{"date":430,"type":34},"2024-03-21",{"date":280,"type":21},{"name":433,"class":75},"Yi Zhang",4,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":442,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":53,"phases":444,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":42},"100559446","supportive-care-intervention-for-outpatient-stem-cell-transplant-patients-100559446","NCT06564233","Supportive Care Intervention for Outpatient Stem Cell Transplant Patients","A Randomized Controlled Trial of an Avatar-based Supportive Care Intervention for Patients Undergoing Outpatient Stem Cell Transplantation","Inclusion Criteria:\n\n* Age 18+\n* Seen for outpatient RIC HCT (prior to D0, generally D-6).\n\nExclusion Criteria:\n\n* Deemed by clinical staff or research assistant (RA) to be unable to converse with an avatar, due to: severe, uncorrectable hearing or vision impairment; severe speech impairment that precludes understanding by staff (or by the avatar).\n* Not fluent in English.","19 Years",{"count":270,"type":21},[55],"The overall goal of this study is to assess the efficacy of the care.coach Avatar™ in improving anxiety and quality of life for patients undergoing outpatient transplant. After care.coach Avatar™ content and scheduling (\"digital intervention\" or \"program\") has been optimized for outpatient allogeneic hematopoietic stem cell transplantation (HCT), a randomized controlled trial (RCT) will be conducted of the digital versus usual supportive care program for outpatient HCT recipients. Potential improvements in anxiety and quality of life will be evaluated, with the intent of increasing comfortability with outpatient transplant and expanding the population of eligible patients willing to receive their transplants in an outpatient setting.",[25,447],"Cancer",[449,450],"health coaching","conversational relational agents","2026-03-04",{"date":453,"type":34},"2026-03-06",{"date":455,"type":34},"2024-10-21",{"date":457,"type":21},"2026-11-29",{"name":459,"class":460},"Victor Wang","INDUSTRY",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":293,"enrollmentInfo":468,"targetDuration":4,"studyType":53,"phases":470,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":42},"100626967","phase-3-comparison-of-etamsylate-versus-placebo-to-prevent-bleeding-in-hsct-100626967","NCT07442513","Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT","Comparison of Etamsylate Versus Placebo to Prevent Bleeding in Hematopoietic Stem Cell Transplantation Recipients：a Randomized, Double-blind, Phase 3, Clinical Study","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive), regardless of gender;\n2. Patients diagnosed with a hematological disease requiring hematopoietic stem cell transplantation;\n3. Expected platelet count ≤ 10 x 10⁹\u002FL persisting for 5 days or more;\n4. Normal coagulation function;\n5. Adequate organ function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 times the Upper Limit of Normal (ULN), Total Bilirubin ≤ 2 x ULN; Serum Creatinine ≤ 2 x ULN; Creatinine Clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Echocardiography (ECHO);\n6. Voluntary provision of signed informed consent, with the ability to understand and comply with all study requirements.\n\nExclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia confirmed according to WHO diagnostic criteria;\n2. Pregnant or breastfeeding women, and women of childbearing potential unwilling to use effective contraception;\n3. Presence of active bleeding or infection;\n4. History of diagnosed primary immune thrombocytopenia or hemolytic uremic syndrome;\n5. Patients with known hereditary or acquired hemorrhagic disorders;\n6. Patients receiving anticoagulant or antiplatelet therapy;\n7. Patients with severe cardiac insufficiency (left ventricular ejection fraction \\[EF\\] \\\u003C 60%); or severe arrhythmias: history of clinically significant QTc prolongation (male \\> 450 ms; female \\> 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block; myocardial infarction within 1 year prior to enrollment; or symptomatic coronary artery disease requiring medication; patients with severe liver impairment (liver function indices \\[ALT, TBIL\\] \\> 3 times the upper limit of normal \\[ULN\\]);\n8. Patients with severe pulmonary insufficiency (obstructive and\u002For restrictive ventilatory defects);\n9. Patients with severe renal insufficiency (renal function index \\[Cr\\] \\> 2 times ULN); or 24-hour urinary creatinine clearance rate (Ccr) \\\u003C 50 ml\u002Fmin;\n10. Patients with mental disorders or other conditions preventing provision of informed consent and compliance with study treatment and procedural requirements;\n11. Other reasons deemed by the investigator to make the patient ineligible for inclusion.",{"count":469,"type":21},404,[471],"PHASE3","This study employs a prospective, randomized, double-blind, placebo-controlled design. It aims to compare the efficacy of etamsylate versus placebo in preventing bleeding complications in patients with thrombocytopenia following hematopoietic stem cell transplantation.",[25,474],"Thrombocytopenia",[476,477,478,479],"etamsylate","Hematopoietic Stem Cell Transplantation recipients","thrombocytopenia","bleeding events","2026-02-25",{"date":482,"type":34},"2026-03-02",{"date":484,"type":34},"2025-12-16",{"date":486,"type":21},"2027-10-31",{"name":488,"class":75},"First Affiliated Hospital of Zhejiang University",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":53,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":506,"locationsCount":508},"100491584","cultural-tailoring-and-pilot-testing-of-an-inpatient-yoga-therapy-program-for-cancer-patients-undergoing-hematopoietic-stem-cell-transplantation-in-india-tanzania-and-the-united-states-100491584","NCT05681026","Cultural Tailoring and Pilot Testing of an Inpatient Yoga Therapy Program for Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation in India, Tanzania, and the United States","Inclusion Criteria:\n\n1. Cancer patients scheduled to undergo an autologous or allogeneic HSCT at MD Anderson, HCG, or MNH;\n2. Age 18 or older;\n3. English, Hindi, or Swahili speaking;\n4. Able to sign a written informed consent and be willing to follow protocol requirements.\n\nExclusion Criteria:\n\n* Extreme mobility issues that preclude participating in the YT;\n* Major thought disorders such as schizophrenia or uncontrolled bipolar disorder;\n* HCT comorbidity score of 3 or higher, excluding cancer diagnoses",{"count":496,"type":21},60,[55],"To develop and measure the effects of a culturally sensitive yoga program for inpatients",[25,447],"2026-02-24",{"date":502,"type":34},"2026-02-27",{"date":504,"type":34},"2023-08-28",{"date":338,"type":21},{"name":507,"class":75},"M.D. Anderson Cancer Center",3,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":4},"100623008","integrating-vaccination-into-hospital-care-pathways-for-vulnerable-patients-100623008","NCT07391046","Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients","Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients: A Scalable and Sustainable Model","AMBU-VAX","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Conditions not included among the predefined eligibility criteria",{"count":518,"type":21},1500,"AMBU-VAX is a prospective, single-center observational study designed to develop and implement an organizational model for delivering recommended vaccinations within a hospital setting.\n\nThe study targets adult and elderly patients with chronic diseases or immunocompromising conditions who are eligible for vaccination according to national immunization guidelines. Vaccination is actively proposed during outpatient visits, hospital admissions, or at discharge and, when accepted, administered within the hospital or coordinated with local public health vaccination services.\n\nThe study aims to evaluate the feasibility, uptake, and completion of hospital-based vaccination pathways and to support integration between hospital and territorial prevention services for vulnerable populations.",[521,522,523,524,525,25,447,526,527,528,529],"Chronic Disease","Immunocompromised","HIV Infection","Chronic Kidney Disease","Solid Organ Transplantation","Autoimmune Diseases","Inflammatory Bowel Disease","Asplenia","Frailty","2026-01-29",{"date":532,"type":34},"2026-02-05",{"date":534,"type":21},"2026-02",{"date":536,"type":21},"2027-02",{"name":538,"class":75},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":546,"maxAge":50,"enrollmentInfo":547,"targetDuration":4,"studyType":53,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":555,"leadSponsor":557,"locationsCount":42},"100621797","phase-1-zoledronate-to-prevent-bone-health-complications-in-pediatric-hematopoietic-stem-cell-transplant-survivors-100621797","NCT07375290","Zoledronate to Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors","Early Intervention With Zoledronate to Safely Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors","Inclusion Criteria:\n\n* Patients ≥5 and ≤18 years old who are preparing for HSCT with a height-for-age corrected DXA Z-score of \\\u003C-2.0 and admitted to a CCHMC inpatient unit.\n* Patients ≥5 and ≤18 years old recovering from HSCT and who have developed de novo acute or chronic GVHD and are admitted to a CCHMC inpatient unit.\n\nExclusion Criteria:\n\n* Age \\\u003C5 years and \\>18 years\n* Patients with Fanconi anemia or other radiation-sensitive syndromes with increased malignancy risk\n* history of prior bisphosphonate use\n* low 25-OH vitamin D levels (\\\u003C20 ng\u002FmL)\n* active febrile illness\n* uncontrolled infection\n* Elevated creatinine at the time of enrollment, history or renal failure, or documented low glomerular filtration rate (GFR≤90)\n* Active bone disease including history of abnormal PTH level for any reason, active bone fracture\u002Fhealing, or primary disorder of bone development or metabolism.\n* Women who are pregnant or breast feeding.","5 Years",{"count":548,"type":21},20,[112],"The purpose of this pilot study is to investigate the safety and preliminarily assess efficacy of early intervention with zoledronate in high risk pediatric hematopoietic stem cell transplantation (HSCT) patients to prevent the development of bone disease and fractures and reduce potential pain and suffering.",[25],"2026-01-21",{"date":530,"type":34},{"date":534,"type":21},{"date":556,"type":21},"2028-11",{"name":558,"class":75},"Children's Hospital Medical Center, Cincinnati",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":53,"phases":567,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":42},"100611733","early-phase-1-prevention-of-graft-rejection-in-hematopoietic-stem-cell-transplant-hsct-recipients-100611733","NCT07244419","Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients","Emapalumab for the Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients","Inclusion Criteria:\n\n* All patients undergoing allogeneic HSCT at our institution will be evaluated for graft rejection risk factors. Patients deemed high risk for graft rejection will have 2 or more of the following: mismatched or haploidentical donor, ex vivo t-cell depleted graft, prior history of graft rejection.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any constituent of the study medication.",{"count":548,"type":21},[568],"EARLY_PHASE1","The investigators hypothesize that graft rejection after hematopoietic stem cell transplant (HSCT) is primarily driven by interferon gamma, and prophylactic interferon gamma inhibition in high-risk patients will prevent graft rejection. Additionally, knowledge of emapalumab PK\u002FPD and in vitro mechanistic effects of emapalumab in this novel setting will guide optimization of dosing regimens and treatment approaches in future studies.",[25,571],"Graft Failure",{"date":573,"type":34},"2026-01-22",{"date":575,"type":34},"2026-01-07",{"date":577,"type":21},"2029-08",{"name":558,"class":75},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":587,"targetDuration":546,"studyType":22,"phases":4,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":602},"100619813","cardiovascular-outcomes-and-risk-evaluation-among-recipients-of-hematopoietic-stem-cell-transplantation-100619813","NCT07349498","Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation","Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation (CORE-HCT): A Prospective Multicenter Observational Study","CORE-HCT","Inclusion Criteria:\n\n* Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.\n\nExclusion Criteria:\n\n* Any other conditions that, in the opinion of the investigator, can interfere with the interpretation of data.\n* Patient request to withdraw from the study.",{"count":588,"type":21},10000,"This is a prospective, multicenter observational study for recipients of hematopoietic stem cell transplantation. Patients who underwent hematopoietic stem cell transplantation at the participating centers will be entrolled in the study. The clinical characteristics, laboratory profiles, management measures, and clinical outcomes such as post-transplant cardiovascular events will be prospectively collected.",[25,591,592],"Transplant Complication","Cardiovascular Events","2026-01-09",{"date":595,"type":34},"2026-01-16",{"date":597,"type":34},"2026-01-01",{"date":599,"type":21},"2036-12-31",{"name":601,"class":75},"Peking University People's Hospital",16,{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":293,"enrollmentInfo":611,"targetDuration":4,"studyType":53,"phases":613,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":42},"100554079","employment-support-after-hematopoietic-stem-cell-transplantation-100554079","NCT06494423","Employment Support After Hematopoietic Stem Cell Transplantation","Supportive Care Intervention Development to Address Employment Concerns After Allogeneic Hematopoietic Stem Cell Transplantation","WorkS","Inclusion Criteria:\n\n* Received an allogeneic HSCT within the past six months to treat a hematological malignancy.\n* Screen positive for work-related concerns (i.e., responds \"yes\" to the question, \"Are you concerned about your ability to return to work in the coming six months?\")\n\nExclusion Criteria:\n\n* Patients with acute psychiatric or cognitive conditions which the treating clinician believes prohibits informed consent or compliance with the study procedures\n* We will not enroll the following special populations: adults unable to consent, individuals not yet adults, pregnant women, and prisoners.",{"count":612,"type":21},35,[55],"This is a feasibility study of a Work Support (WorkS) intervention designed to ameliorate employment challenges for people preparing to return to work after allogeneic stem cell transplantation. The aim of this study is to evaluate \"proof of concept\" by:\n\n1. examining the feasibility and acceptability of the WorkS intervention and the study procedures, and\n2. exploring the preliminary effects of WorkS for improving patient-reported return-to-work self-efficacy, work status, quality of life, and financial toxicity.",[25],[617],"Return to Work","2025-12-12",{"date":620,"type":34},"2025-12-19",{"date":622,"type":34},"2024-07-31",{"date":624,"type":21},"2027-12-31",{"name":626,"class":75},"MGH Institute of Health Professions",{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":396,"maxAge":84,"enrollmentInfo":634,"targetDuration":4,"studyType":53,"phases":635,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":42},"100511555","phase-2-inotuzumab-ozogamicin-in-the-treatment-of-mrd-after-hsct-of-all-100511555","NCT05940961","Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL","A Multicenter Prospective Clinical Study of Inotuzumab Ozogamicin (INO) in the Treatment of Minimal Residual Disease Recurrent After Hematopoietic Stem Cell Transplantation of Acute Lymphoblastic Leukemia (ALL)","Inclusion Criteria:\n\n1. Patients aged ≥ 15 and ≤ 65 years.\n2. Patients diagnosed with CD22+ B-ALL according to 2023 NCCN Acute Lymphoblasts Leukaemias diagnosis standard.\n3. CD22+ B-ALL patients with MRD recurrence after HSCT. Ph+ ALL patients were eligible if treatment with 1 or more second-generation BCR::ABL1 tyrosine kinase inhibitors (TKIs) had failed,\n4. ECOG performance status score less than 3.\n5. Expected survival time #3 months.\n6. Patients without serious heart, lung, liver, or kidney disease.\n7. Ability to understand and voluntarily provide informed consent.\n\nExclusion Criteria:\n\n1. Patients who are allergic to the study drug or drugs with similar chemical structures.\n2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.\n3. Active infection.\n4. Active bleeding.\n5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.\n6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.\n7. Liver function abnormalities (total bilirubin \\> 1.5 times the upper limit of the normal range, ALT\u002FAST \\> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT\u002FAST \\> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \\> 1.5 times the upper limit of the normal value).\n8. Patients with a history of clinically significant QTc interval prolongation (male \\> 450 ms; female \\> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.\n9. Surgery on the main organs within the past six weeks.\n10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.\n11. Patients who have received organ transplants (excepting bone marrow transplantation).\n12. Patients not suitable for the study according to the investigator's assessment.",{"count":5,"type":21},[113],"As part of postremission consolidative therapy, the decision to proceed with hematopoietic stem cell transplantation is a recommendable regimen in ALL therapy. However, The recurrence rate is high after transplantation. Minimal Residual Disease (MRD) is an important factor affecting the effect of HSCT. The hematologic recurrence rate of MRD-positive patients with adult ALL is high.\n\nMRD- is associated with better prognosis. Therefore, maintaining MRD- after transplantation is necessary for long-term survival. The purpose of this study is to explore the efficacy and safety of Inotuzumab Ozogamicin in the treatment of minimal residual disease recurrence after HSCT of ALL patients.",[17,638,25],"MRD-positive","2025-11-18",{"date":641,"type":34},"2025-11-21",{"date":643,"type":34},"2022-08-01",{"date":645,"type":21},"2026-08-01",{"name":647,"class":75},"Sheng-Li Xue, MD"]