[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416793":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":38,"responsibleParty":108,"collaborators":110,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":19,"studyType":127,"phases":128,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":41,"whyStopped":19,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Human T Lymphoid Progenitor (HTLP) injection","EXPERIMENTAL","HTLP cellular product obtained after 7 days of culture of immune-selected CB",[13],"Drug: Human T Lymphoid Progenitor (HTLP) injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","The HTLP cell suspension will be injected intravenously at the time of UCB HSCT on D0",[9],null,[21,24],{"name":22,"affiliation":5,"role":23},"Olivier HERMINE, PhD & MD","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":26,"role":27},"Elisa MAGRIN, MD","Département de Biothérapie : Hôpital Necker Enfants malades","STUDY_DIRECTOR",[29,33],{"name":22,"role":30,"phone":31,"phoneExt":19,"email":32},"CONTACT","+33 144495282","olivier.hermine@aphp.fr",{"name":34,"role":30,"phone":35,"phoneExt":36,"email":37},"Nelly Briand, PhD","01 44 38 18 62","+33","nelly.briand@aphp.fr",[39,56,69,82,96],{"facility":40,"status":41,"city":42,"state":19,"zip":19,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hôpital Saint Louis","RECRUITING","Paris","France","FR",{"type":46,"coordinates":47},"Point",[48,49],2.3488,48.85341,{"lat":49,"lon":48},[52],{"name":53,"role":30,"phone":54,"phoneExt":19,"email":55},"Nicolas BOISSEL, MD, PhD","+33 1 42 49 96 43","nicolas.boissel@aphp.fr",{"facility":57,"status":41,"city":58,"state":19,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Service d'Hématologie et thérapie cellulaire \u002F CHU of Bordeaux","Pessac","33604",{"type":46,"coordinates":61},[62,63],-0.6324,44.80565,{"lat":63,"lon":62},[66],{"name":67,"role":30,"phone":19,"phoneExt":19,"email":68},"Edouard FORCADE, PhD & MD","edouard.forcade@chu-bordeaux.fr",{"facility":70,"status":41,"city":71,"state":19,"zip":19,"country":43,"countryCode":44,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"IUCT Oncopole Toulouse","Toulouse",{"type":46,"coordinates":73},[74,75],1.44367,43.60426,{"lat":75,"lon":74},[78],{"name":79,"role":30,"phone":80,"phoneExt":19,"email":81},"Anne HUYNH, PhD, MD","05 31 15 71 91","huynh.anne@iuct-oncopole.fr",{"facility":83,"status":84,"city":85,"state":19,"zip":19,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Institut Gustave Roussy","NOT_YET_RECRUITING","Villejuif",{"type":46,"coordinates":87},[88,89],2.35992,48.7939,{"lat":89,"lon":88},[92],{"name":93,"role":30,"phone":94,"phoneExt":19,"email":95},"Jean-Henri BOURHIS, PhD MD","+33 1 42 11 53 82","jean-henri.bourhuis@gustaveroussy.fr",{"facility":97,"status":41,"city":42,"state":98,"zip":99,"country":43,"countryCode":44,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"Hematology department \u002F Necker Children's Hospital","Île-de-France Region","75015",{"type":46,"coordinates":101},[48,49],{"lat":49,"lon":48},[104,105],{"name":22,"role":30,"phone":31,"phoneExt":19,"email":32},{"name":106,"role":30,"phone":19,"phoneExt":19,"email":107},"Felipe SUAREZ, PhD & MD","felipe.suarez@aphp.fr",{"type":109,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[111],{"name":112,"class":6},"URC-CIC Paris Descartes Necker Cochin","100416793","phase-1-study-evaluating-the-safety-and-the-efficacy-of-human-t-lymphoid-progenitor-htlp-injection-to-accelerate-immune-reconstitution-after-umbilical-cord-blood-ucb-transplantation-in-adult-patients-with-hematologic-malignancies-htlp-onco-100416793",false,"NCT04707300","Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies (HTLP-ONCO)","A Phase I\u002FII Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies","HTLP-ONCO","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old and \\\u003C66 years old) at the time of inclusion and eligible for an allogeneic stem cells transplantation and fit to receive the specified conditioning regimen\n* Patients with hematologic malignancies\n* Absence of a matched - related sibling donor (MSD) or a matched unrelated donor (MUD) 10\u002F10\n* Presence of two UCB units with the following criteria\\*: HLA- matched 4\u002F8, 5\u002F8, 6\u002F8, 7\u002F8 or 8\u002F8 for HLA- A, -B, -C and DRB1 loci\n\nAND\n\n• Presence of at least one UCB unit with the following criteria\\*: ≥ 3 x 10e7 TNC\u002Fkg or ≥ 1.5 10e5 CD34+\u002Fkg pre- freezing\n\n\\* For the UCB taken into HTLP culture, the CD34+ content does not need to meet the above cellularity criteria, as expansion during HTLP culture has been proven to ensure the appropriate number of CD7+ needed for each dose.\n\nThe non- cultured UCB will be chosen to have a higher CD34+ cell content in order to enable long- term hematopoietic engraftment\n\n* Absence of Donor Specific Antibodies (DSA) with a MFI \\> 5000\n* Patient affiliated to social security\n* Written, informed consent of the patient\n\nExclusion Criteria:\n\n* Any of the standard contraindications to allogeneic transplant\n* Left ventricular ejection fraction \\\u003C50%\n* Abnormal biochemistry results (ALT\u002FAST\\>10xULN, total bilirubin\\>2.5xULN, creatinin clearance \\\u003C60ml\u002Fmin)\n* Inability to understand and provide informed consent\n* Concomitant infectious disease: HTLV-I, HIV-I or HIV-II\n* Pregnancy or breastfeeding for women of childbearing potential\n* Patients with progressive hematologic malignancies\n* Previous participation within one month before inclusion in another protocol in which drugs may influence immune reconstitution of bone marrow transplantation","ALL","18 Years","66 Years",{"count":125,"type":126},10,"ESTIMATED","INTERVENTIONAL",[129,130],"PHASE1","PHASE2","This is an open-labelled and non-controlled Phase I\u002FII clinical trial, evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after umbilical cord blood (UCB) transplantation in adult patients with hematologic malignancies. The dose limiting toxicity of HTLP injection will be evaluated using a model-based design.",[133],"Hematologic Malignancy",[135,136,137,138,139],"acute myeloid leukemia","minimal residual disease","hematologic malignancies","human T Lymphoid Progenitor","umbilical cord blood transplantation","2026-08-10",{"date":142,"type":143},"2026-08-12","ACTUAL",{"date":145,"type":143},"2022-02-16",{"date":147,"type":126},"2029-02",{"name":5,"class":6},5]