Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-02-21 @ 10:02 AM
Study NCT ID:
NCT01919866
Status:
UNKNOWN
Last Update Posted:
2014-10-08
First Post:
2013-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000741', 'term': 'Anemia, Aplastic'}], 'ancestors': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-07', 'studyFirstSubmitDate': '2013-08-07', 'studyFirstSubmitQcDate': '2013-08-08', 'lastUpdatePostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engraftment rate and transplant related mortality', 'timeFrame': '365 days', 'description': 'engraftment rate will be evaluated by leukocyte counts in peripheral blood . Definition of engraftment: \\>500 neutrophiles/µl blood. Transplant related mortality will be evaluated at day 100 and day 365 post transplant'}], 'secondaryOutcomes': [{'measure': 'Graft versus Host disease and speed of immune reconstitution', 'timeFrame': '365 days', 'description': 'Incidence of acute and chronic GvHD will be evaluated according to Glucksberg criteria. Immune recovery will be evaluated by flow cytometry. Percentages and numbers of T, B and NK cells will be measured weekly until day 100, afterwards on day 180 and 365.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Leukemias', 'Aplastic Anemia', 'Childhood Solid Tumor']}, 'descriptionModule': {'briefSummary': 'Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease)\n* AML in complete remission of refractory\n* MDS RAEB-t/secondary AML\n* ALL\n* CML\n* Non-Hodgkin Lymphoma / Hodgkin Lymphoma\n* non malignant diseases (aplastic anemia, thalassemia, SCID)\n* relapsed Neuroblastoma\n* relapsed soft tissue sarcoma (Rhabdomyosarcoma, Ewing sarcoma, PNET\n* soft tissue sarcoma with primary bone metastases or bone marrow\n* in whom no matched donor was available,\n\nExclusion Criteria:\n\n* \\< 6 months after previous HSCT\n* active cerebral seizure conditions\n* massive progression of leukemias or solid tumours before planned trp.\n* left ventricular ejection fraction \\<25%\n* creatinine clearance \\<40ml/min before conditioning\n* respiratory insufficiency with oxygen demand or DLCO \\<30%\n* Bilirubin \\>4mg/dl, GOT/GPT \\>400\n* severe infection (HIV, Aspergillosis)\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01919866', 'briefTitle': 'Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital Tuebingen"}, 'officialTitle': 'Haploidentical Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells in Pediatric Patients With Refractory Hematological and Oncological Diseases', 'orgStudyIdInfo': {'id': '1075/01 PEI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transplantation of CD3/CD19 depleted stem cells', 'description': 'Patients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW', 'interventionNames': ['Other: Transplantation of CD3/CD19 depleted stem cells']}], 'interventions': [{'name': 'Transplantation of CD3/CD19 depleted stem cells', 'type': 'OTHER', 'armGroupLabels': ['Transplantation of CD3/CD19 depleted stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Urban, MD', 'role': 'CONTACT', 'email': 'christian.urban@medunigraz.at'}], 'facility': "University Children's Hospital", 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6120', 'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christine Mauz-Körholz, MD', 'role': 'CONTACT', 'email': 'christine.mauz-koerholz@medizin.uni-halle'}], 'facility': "University Children's Hospital", 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Sauer, MD', 'role': 'CONTACT', 'email': 'sauer.martin@mh-hannover.de'}], 'facility': 'Medizinische Hochschule Zentrum für Kinderheilkunde', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '7745', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernd Gruhn, MD', 'role': 'CONTACT', 'email': 'bernd.gruhn@med.uni-jena.de'}], 'facility': "University Children's Hospital", 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Lang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "University Children's Hospital", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Peter Lang, MD', 'role': 'CONTACT', 'email': 'peter.lang@med.uni-tuebingen.de', 'phone': '+4970712981386'}, {'name': 'Rupert Handgretinger, MD', 'role': 'CONTACT', 'email': 'rupert.handgretinger@med.uni-tuebingen.de', 'phone': '+4970712984744'}], 'overallOfficials': [{'name': 'Peter Lang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital Tuebingen"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital Tuebingen", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Peter Lang', 'investigatorAffiliation': "University Children's Hospital Tuebingen"}}}}