[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cord-blood-stem-cell-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cord-blood-stem-cell-transplantation":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"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":54},"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",3,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100188430","the-collection-and-storage-of-umbilical-cord-blood-for-transplantation-100188430","NCT01728545","The Collection and Storage of Umbilical Cord Blood for Transplantation","Inclusion Criteria\n\n1. Pregnant women age 18 or older. Cord blood will not be collected from a minor.\n2. Able to give verbal informed consent prior to collection of the cord blood.\n3. Able to give written informed consent prior to collection of the cord blood.\n4. Willing to provide a personal and family medical history (if available) of herself and the biologic father (if available), prior to or following collection of the cord blood.\n5. Willing to consent to testing of her blood and the cord blood for infectious diseases, including human immunodeficiency virus (HIV), human T cell lymphotrophic virus (HTLV), hepatitis B and C, cytomegalovirus (CMV), syphilis (RPR), Trypanosoma cruzi (Chagas) and West Nile Virus (WNV). Incomplete tests or positive infectious disease testing results may result in the cord blood unit being deemed unacceptable for clinical use.\n6. Willing to consent to testing the cord blood for HLA type, ABO\u002FRhD type, newborn screening and microbial cultures.\n\nExclusion Criteria:\n\nN\u002FA",true,"FEMALE","18 Years",{"count":65,"type":22},250000,"OBSERVATIONAL","The goal of this study is to collect blood samples from the umbilical cords of newborn babies, as soon as they are delivered, and to place these samples in the MD Anderson Cord Blood Bank. Your sample may be included in the National Cord Blood Inventory (NCBI) which is part of the CW Bill Young Cell Transplantation Program. The NCBI is a federally-supported program to assist in the collection of cord blood. Cord blood will be made available to patients through The National Marrow Donor Program (NMDP). These samples may then be offered to MD Anderson and other institutions for patients who need a bone marrow transplant and do not have a donor. The MD Anderson Cord Blood Bank will have the rights to release cord blood units to these institutions around the world according to established bone marrow transplant donor criteria, for a fee to cover costs.\n\nCord blood samples that are collected and then do not meet the clinical requirements for patient use may also be used at MD Anderson or other institutions either for research or for quality purposes to improve cord blood banking procedures. If not suitable for patient use or for research purposes, the cord blood unit may be thrown away.",[32,38,69],"Hematopoietic Stem Cell Transplantation",[71,72,73,74,75,76,69,77,78,79,80,81,82],"Cord blood registry","Umbilical Cord Blood","fetal blood","placenta","Placental Blood Stem Cell Transplantation","hematopoietic progenitor cells","cord blood unit total nucleated cell","TNC","CD34-positive(+) cell","human leukocyte antigen","HLA","allogeneic transplantation","RECRUITING","2019-05-10",{"date":86,"type":46},"2019-05-13",{"date":88,"type":46},"2005-04",{"date":90,"type":22},"2099-04",{"name":92,"class":53},"M.D. Anderson Cancer Center",1]