[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621612":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":38,"centralContacts":45,"locations":51,"responsibleParty":93,"collaborators":96,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":37,"studyType":118,"phases":119,"briefSummary":122,"conditions":123,"keywords":129,"overallStatus":137,"whyStopped":37,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"University of Manchester","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I: T replete cord blood transplant + conditioning + 1 day Granulocytes","ACTIVE_COMPARATOR","All participants will receive a T replete cord blood transplant with a standardised conditioning regimen involving Fludarabine, Cyclophosphamide, Thiotepa, and TBI. A single pool of irradiated granulocytes will be given to participants for 1 day starting on the day of transplant.",[13],"Biological: Cord blood transplantation + conditioning + granulocytes of variable days according to study design",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase I: T replete cord blood transplant + conditioning + 3 day Granulocytes","All participants will receive a T replete cord blood transplant with a standardised conditioning regimen involving Fludarabine, Cyclophosphamide, Thiotepa, and TBI. A single pool of irradiated granulocytes will be given daily to participants for 3 days starting on the day of transplant.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Active Comparator: Phase I: T replete cord blood transplant + conditioning + 5 day Granulocytes","All participants will receive a T replete cord blood transplant with a standardised conditioning regimen involving Fludarabine, Cyclophosphamide, Thiotepa, and TBI. A single pool of irradiated granulocytes will be given daily to participants for 5 days starting on the day of transplant.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Active Comparator: Phase I: T replete cord blood transplant + conditioning + 7 day Granulocytes","All participants will receive a T replete cord blood transplant with a standardised conditioning regimen involving Fludarabine, Cyclophosphamide, Thiotepa, and TBI. A single pool of irradiated granulocytes will be given daily to participants for 7 days starting on the day of transplant.",[13],{"label":27,"type":28,"description":29,"interventionNames":30},"Phase II: T replete cord blood transplant + conditioning + Granulocytes at Recommended Phase II Dose","EXPERIMENTAL","All participants will receive a T replete cord blood transplant with a standardised conditioning regimen involving Fludarabine, Cyclophosphamide, Thiotepa, and TBI. A single pool of irradiated granulocytes will be given daily to all participants- at the Recommended Phase II Dose (RP2D)",[13],[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","Cord blood transplantation + conditioning + granulocytes of variable days according to study design","All participants will receive a T replete cord blood transplant with a standardised conditioning regimen involving Fludarabine, Cyclophosphamide, Thiotepa, and TBI. A single pool of irradiated granulocytes will be given daily to all participants- but for a variable number of days starting on the day of transplant according to study design (1,3,5 or 7 days). The study consists of two phases- Phase 1 has two components (dose escalation and dose optimisation) to identify the Recommended Phase II Dose (RP2D) of granulocytes. Phase 2 will assess preliminary efficacy based Relapse Free Survival at 1 year.",[19,23,9,15,27],null,[39,42],{"name":40,"affiliation":5,"role":41},"Mark Williams, BA MB BChir PhD MRCP FRCPath","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":44,"role":41},"Mili N Shah, BSc MBBS MRCP FRCPath","Kings College Hospital NHS Trust",[46],{"name":47,"role":48,"phone":49,"phoneExt":37,"email":50},"Johnna Ward GRACE Trial Manager","CONTACT","02032999000","kch-tr.gracestudy@nhs.net",[52,67,79],{"facility":44,"status":37,"city":53,"state":37,"zip":37,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"London","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-0.12574,51.50853,{"lat":60,"lon":59},[63,66],{"name":64,"role":48,"phone":65,"phoneExt":37,"email":50},"Johnna Ward Trial Manager\u002FResearch Nurse","+44 (0) 20 3299 9000",{"name":43,"role":41,"phone":37,"phoneExt":37,"email":37},{"facility":68,"status":37,"city":53,"state":37,"zip":37,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"The Royal Marsden Hospital NHS Foundation Trust",{"type":57,"coordinates":70},[59,60],{"lat":60,"lon":59},[73,77],{"name":74,"role":48,"phone":75,"phoneExt":37,"email":76},"Francesca Temple-Brown Senior Trials Manager- Transplant","0044 20 3186 5004","francesca.temple-brown@rmh.nhs.uk",{"name":78,"role":41,"phone":37,"phoneExt":37,"email":37},"Chloe Anthias",{"facility":80,"status":37,"city":81,"state":37,"zip":37,"country":54,"countryCode":55,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"The Christie NHS Foundation Trust","Manchester",{"type":57,"coordinates":83},[84,85],-2.23743,53.48095,{"lat":85,"lon":84},[88,91],{"name":89,"role":48,"phone":37,"phoneExt":37,"email":90},"Jake Healey Senior Trial Coordinator","jake.healey@nhs.net",{"name":92,"role":41,"phone":37,"phoneExt":37,"email":37},"John Chadwick, MBBS, MRes, PhD",{"type":41,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Mark Williams","Chief Investigator",[97,99,101,102],{"name":98,"class":6},"King's College Hospital NHS Trust",{"name":100,"class":6},"Institute of Cancer Research, United Kingdom",{"name":80,"class":6},{"name":103,"class":6},"Royal Marsden NHS Foundation Trust","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":116,"type":117},50,"ESTIMATED","INTERVENTIONAL",[120,121],"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.",[124,125,126,127,128],"Acute Myeloid Leukemia","Stem Cell Transplantation","Stem Cell Transplantation, Hematopoietic","Cord Blood Stem Cell Transplantation","Cellular Therapy",[130,131,132,133,134,135,136],"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":140,"type":141},"2026-03-11","ACTUAL",{"date":143,"type":117},"2026-02-09",{"date":145,"type":117},"2029-12-31",{"name":5,"class":6},3]