[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stem-cell-transplantation-hematopoietic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stem-cell-transplantation-hematopoietic":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100621612","phase-1-granulocyte-augmented-cord-blood-transplantation-for-poor-risk-leukaemia-100621612",false,"NCT07372885","GRanulocyte Augmented Cord Blood Transplantation for Poor Risk leukaEmia","A Multi-centre Phase I\u002FII Trial of Granulocyte-augmented Cord Blood Transplantation for Young Adults With Very Poor Risk Acute Myeloid Leukaemia.","GRACE","INCLUSION CRITERIA:\n\n1. Availability of a suitable cord blood unit\n2. Age between 16 and 55 years\n3. Primary diagnosis of Acute Myeloid Leukaemia (AML) or MDS\u002FAML (as defined by ICC 2022) fitting one or more of the following criteria:\n\n   * TP53 mutation (single- or multi-hit)\n   * Presence of inv(3) (q21.3q26.2) or t(3;3)(q21.3;q26.2)\n   * Adverse risk (as per ICC 2022) and \\>0.1% MRD by flow cytometry after 2 cycles of induction\n   * AML (any risk) with partial remission (\\\u003C10% blasts) after 2 cycles induction\n   * Early relapse (\\\u003C6 months) after chemotherapy alone (excluding t(16;16), inv(16) or t(8;21))\n4. Bone marrow performed within 28 days of starting conditioning chemotherapy demonstrates either:\n\n   * \\\u003C10% blasts\n   * \\>10% blasts with a hypocellular background (must be discussed with the trial team)\n5. Suitable fitness and organ function as per the following criteria:\n\n   * Glomerular filtration rate \\>50 mL\u002Fmin\u002F1.73m2\n   * Ejection fraction \\>50%\n   * FEV1 \\>65% without dyspnoea on mild activity\n   * AST\u002FALT \\\u003C3 x ULN\n   * Bilirubin \\\u003C1.5 x ULN (excluding Gilbert's syndrome)\n   * Performance Status (ECOG) of 0 or 1\n6. Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must agree to use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after transplant\n\nEXCLUSION CRITERIA:\n\n1. AML Secondary to a myeloproliferative neoplasm\n2. Active CNS disease\n3. Prior allogeneic stem cell transplant\n4. Participation in another clinical trial that would alter any aspect of the transplant protocol or that aims to reduce the subsequent risk of relapse (discuss with trial team if unsure)\n5. History of cardiac arrhythmia\n6. Ischaemic heart disease, valvular heart disease or congestive cardiac failure\n7. Transient ischaemic attack or cerebrovascular accident\n8. Rheumatologic disease (SLE, RA, polymyositis, mixed CTD or polymyalgia rheumatica)\n9. Ulcerative colitis or Crohn's disease\n10. Liver cirrhosis\n11. Presence of an active second malignancy\n12. Uncontrolled infection, including viral reactivation (CMV, EBV)\n13. HIV positive\n14. Hepatitis B\u002FC active infection with measurable viral load (patients with chronic hepatitis B or C infection require clear documentation of absence of cirrhosis by either fibroscan or biopsy, regardless of viral load)\n15. Pregnancy, breastfeeding, unwilling to use contraception\n16. Contraindications to administration of pooled granulocytes\n17. Previous history of sensitivity to granulocytes\n18. Inability of patient to give informed consent\n19. Any other organ dysfunction or co-morbidity that precludes transplant in the opinion of the investigator\n20. Any concern by PI","ALL","16 Years","55 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Allogeneic stem cell transplantation is the only potentially curative therapy for patients with high-risk Acute Myeloid Leukaemia, but relapse is common and remains the leading cause of death. Patients with certain mutations and those transplanted without first clearing their disease have very poor outcomes with most relapsing soon after transplant, and then surviving only a few months. A recent trial at the Royal Manchester Children's Hospital used cord blood stem cells alongside a type of white blood cell called 'granulocytes' and produced surprisingly good outcomes for children with very resistant leukaemia.\n\nGRACE is a clinical trial for adults (\\\u003C55 years) with Acute Myeloid Leukaemia that has not responded to chemotherapy or harbours mutations that predict a very poor response to conventional transplant. Participants will receive a transplant using umbilical cord blood and be given additional infusions of white blood cells, called granulocytes. The trial will be split into two parts:-The first will study the safety of this new approach. The experience of the investigators in children is that granulocyte infusions cause a fever, rash and expansion of another type of white blood cell called lymphocytes. Children that did not have this reaction did not respond to treatment. The investigators therefore believe that the reaction is necessary for the treatment to work, but the investigators must ensure that it is safe in adult patients. The trial design allows the investigators to determine the dose of granulocytes that is best tolerated and most likely to be effective.\n\nThe aim of the second part is to demonstrate that the new treatment is more effective than conventional transplantation.\n\nThe study will be conducted in three NHS transplant centres. Patients will be recruited over 36 months and followed up for a minimum of 1 year. The study is funded by Blood Cancer UK.",[29,30,31,32,33],"Acute Myeloid Leukemia","Stem Cell Transplantation","Stem Cell Transplantation, Hematopoietic","Cord Blood Stem Cell Transplantation","Cellular Therapy",[35,36,37,38,39,40,41],"Grace","granulocyte-augmented cord blood transplantation","poor risk acute myeloid leukaemia","Cord Blood Transplantation","Myelodysplastic Syndrome","TP53","MECOM","NOT_YET_RECRUITING","2026-03-10",{"date":45,"type":46},"2026-03-11","ACTUAL",{"date":48,"type":22},"2026-02-09",{"date":50,"type":22},"2029-12-31",{"name":52,"class":53},"University of Manchester","OTHER",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100619607","vdj-recombination-of-the-b-cell-receptor-following-hematopoietic-stem-cell-transplantation-100619607","NCT07346820","VDJ-recombination of the B-cell Receptor Following Hematopoietic Stem Cell Transplantation","VDJ-recombination of the B-cell Receptor Following Hematopoietic Stem Cell Transplantation, an Observational Study","VReST","Inclusion Criteria:\n\n* Age \\> 18 years.\n* Willing and able to participate in all parts of the study.\n* Signed written consent.\n* Patients with a plasma cell disease of lymphoma that qualify for autologous hematological stem cell transplantation determined by the attending physician OR Patients with a condition for which allogenic stem cell transplantation could be needed and qualify for haematological stem cell transplantation according to the attending physician OR Stem cell donor, donating to a study participant.\n\nExclusion Criteria:\n\n* Unable to give informed consent.\n* Not suitable for participation in the study according to the view of the attending physician.\n* Previous participation in this trial.","18 Years",{"count":64,"type":22},65,"OBSERVATIONAL","When a person undergoes a stem cell transplant-an important procedure used to treat serious blood diseases such as leukaemia, lymphoma, or myeloma-the entire immune system is affected. The transplant essentially \"resets\" the immune system, meaning that the patient loses much of the protection against infections that has been built up over a lifetime. After the transplant, the patient therefore needs to be revaccinated against several diseases, such as tetanus, diphtheria, polio, COVID-19, and pneumococcal disease.\n\nIn this study, we aim to investigate how B cells-the immune cells that produce antibodies-reconstitute after a stem cell transplant. We are particularly interested in a genetic process called VDJ recombination, through which each B cell develops a unique receptor that enables it to recognize and fight a specific virus or bacterium. This process is what makes our immune system so effective. But what happens to this diversity after the entire immune system has been restarted with new stem cells? Does the body regain the same ability to recognize pathogens? Are there differences between patients who receive their own stem cells (autologous transplantation) and those who receive stem cells from another person (allogeneic transplantation)?\n\nTo answer these questions, we will follow patients undergoing stem cell transplantation at Umeå University Hospital. We will collect blood samples before and after the transplantation and will assess whether-and how well-patients generate antibodies in response to the vaccines given after transplantation. Using flow cytometry and genetic analyses, we will examine both which B-cell populations are generated and what their genetic architecture looks like. The goal is to understand how the new immune system is rebuilt after transplantation and, ultimately, to help improve vaccination strategies and infection prevention for this vulnerable patient group",[31,68,69],"V(D)J Recombination","Receptors, Antigen, B-Cel","2026-01-07",{"date":72,"type":46},"2026-01-16",{"date":74,"type":22},"2026-02-01",{"date":76,"type":22},"2036-12-31",{"name":78,"class":53},"Umeå University",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":88,"targetDuration":90,"studyType":65,"phases":4,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":79},"100578669","impact-of-cmv-specific-immune-reconstitution-at-the-end-of-letermovir-prophylaxis-on-the-development-of-late-cytomegalovirus-infection-in-hematopoietic-stem-cell-transplant-recipients-inmunoend-100578669","NCT06814301","Impact of CMV-Specific Immune Reconstitution at the End of Letermovir Prophylaxis on the Development of Late Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Recipients (INMUNOEND)","Impact of CMV-Specific Immune Reconstitution at the End of Letermovir Prophylaxis on the Development of Late Cytomegalovirus Infection in HSCT Recipients (INMUNOEND): a Protocol for a Prospective, Observational, Multicenter Study","INMUNOEND","Inclusion Criteria:\n\n* Age \\>18 years.\n* CMV seropositivity (positive IgG) in the recipient at the time of SCT.\n* First allogeneic hematopoietic stem cell transplant recipient (bone marrow, peripheral blood, or cord blood).\n* Within the first 28 days post-SCT at the time of inclusion.\n* Indication for LTV prophylaxis within the first 28 days post-transplant up to 100 days post-SCT, according to the criteria established in each center.\n\nExclusion Criteria:\n\n* CMV seronegativity (negative IgG) in the recipient at the time of transplant.\n* Previous allogeneic stem cell transplant (patients with a prior autologous transplant are allowed to be included).\n* History of CMV disease in the 6 months prior to inclusion.\n* Need for preemptive therapy in the month prior to inclusion in the study.\n* Received any of the following in the 14 days prior to inclusion: Ganciclovir, valganciclovir, foscarnet, acyclovir (at doses \\>3200 mg orally per day or \\>25 mg\u002Fkg IV per day), valacyclovir (at doses \\>3000 mg orally per day), famciclovir (at doses \\>1500 mg orally per day).\n* Received any of the following in the 30 days prior to screening: Cidofovir, CMV hyperimmune immunoglobulin, any CMV antiviral in the investigational phase.\n* Suspected or confirmed hypersensitivity reaction to the LTV formulation or any of its components.\n* Severe hepatic insufficiency (defined as Child-Pugh class C).\n* History of primary immunodeficiency prior to transplant.\n* Participation in a clinical trial involving the administration of CMV vaccines, other investigational CMV drugs, or monoclonal antibodies.",{"count":89,"type":22},123,"200 Days","Cytomegalovirus (CMV) infection is a common complication in patients undergoing hematopoietic stem cell transplantation (SCT). Fixed-duration letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, it is needed a study to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualization of CMV prophylaxis duration in these patients.\n\nMethods and analysis: INMUNOEND is a multicenter, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post-SCT. Immunological and virological monitorization will be conducted until day +200 post-SCT. The primary outcome variable is the percentage of patients who develop clinically significant CMV infection up to day +200 post-SCT after completing LTV prophylaxis. Data collected will include: baseline characteristics of the hematological diseases and comorbidities, variables related to SCT (i.e. engrafment, graft-versus-host disease, use of letermovir and CMV replication) and variables related to CMV-specific immune reconstitution.",[93,31],"Cytomegalovirus Cell Mediated Immunity",[95,96,97,98,99],"stem cell transplantation","cytomegalovirus","letermovir","prophylaxis","cytomegalovirus immunity","2025-11-21",{"date":102,"type":46},"2025-11-28",{"date":104,"type":22},"2025-12-01",{"date":106,"type":22},"2027-09",{"name":108,"class":53},"Maimónides Biomedical Research Institute of Córdoba"]