Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00856505
Status:
UNKNOWN
Last Update Posted:
2009-03-05
First Post:
2009-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Calcineurin Inhibitor Free GvHD Prophylaxis in Allogeneic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-04', 'studyFirstSubmitDate': '2009-03-04', 'studyFirstSubmitQcDate': '2009-03-04', 'lastUpdatePostDateStruct': {'date': '2009-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity according to CTCAE v3.0', 'timeFrame': 'after 100 days and one year after treatment start'}], 'secondaryOutcomes': [{'measure': 'Hematopoietic engraftment', 'timeFrame': 'day 30 after stem cell transplantation'}, {'measure': 'Incidence of acute and chronic GvHD', 'timeFrame': 'one year after stem cell transplantation'}, {'measure': 'Progression free survival', 'timeFrame': 'Day 100 and one year after stem cell transplantation'}, {'measure': 'Overall survival', 'timeFrame': 'day 100 and one year after stem cell transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hematopoietic Stem Cell Transplantation', 'Drug Therapy, Combination', 'Immunosuppression'], 'conditions': ['Hematologic Diseases']}, 'referencesModule': {'references': [{'pmid': '33755792', 'type': 'DERIVED', 'citation': 'Schafer H, Blumel-Lehmann J, Ihorst G, Bertz H, Wasch R, Zeiser R, Finke J, Marks R. A prospective single-center study on CNI-free GVHD prophylaxis with everolimus plus mycophenolate mofetil in allogeneic HCT. Ann Hematol. 2021 Aug;100(8):2095-2103. doi: 10.1007/s00277-021-04487-y. Epub 2021 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor immune cells. The hypothesis for this study is, that replacing calcineurin inhibitors by everolimus and mycophenolate as GvHD prophylaxis not only reduces toxicity of the treatment but also improves tolerance induction of the donor T cells toward the host, eventually increasing the safety of stem cell transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of hematologic malignancies, indicated for allogeneic stem cell transplantation:\n* acute myeloid leukemia (AML), in CR1, ≥ CR2, primary refractory, relapse\n* chronic myeloid leukemia (CML), in chronic phase, in acceleration or blast crisis\n* myelodysplastic syndrome (MDS), RA/RARS (transfusion dependent), RAEB, RAEB-t and CMML\n* Lymphoma:\n\n * plasmocytoma\n * immunocytoma (M. Waldenström)\n * chronic-lymphatic leukemia (CLL)\n * additional low and high grade Non-Hodgkin Lymphoma\n* Hodgkins disease\n* HLA-matched (HLA-A, -B, -DRB1) related or unrelated donor available\n* Signed informed consent\n\nExclusion Criteria:\n\n* CNS involvement by underlying disease\n* Pulmonary disease with VC \\< 55%, DLCO \\< 40%\n* Cardiac ejection fraction \\< 30%, uncontrollable arrhythmia\n* Creatinin \\> 1,5 mg/dl or Creatinin-Clearance \\< 30 ml/min\n* Bilirubin \\> 2 mg/dl\n* Active Hepatitis B or C\n* HIV serologic positive\n* Pregnancy and lactation\n* Pre-menstrual women without medical safe contraception\n* Participation on another clinical trial in between 30 days before start or during the study only if the clinical trial interferes with the outcome measures.\n* Known allergy to study medication or ingredients of the formulation\n* Drug- or alcohol abuse\n* Non-compliance'}, 'identificationModule': {'nctId': 'NCT00856505', 'briefTitle': 'Safety Study of Calcineurin Inhibitor Free GvHD Prophylaxis in Allogeneic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Everolimus and Mycophenolate Sodium as GvHD Prophylaxis in Allogeneic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': '00557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus and mycophenolate sodium', 'description': 'Combination of experimental immunosuppressants for GvHD prophylaxis', 'interventionNames': ['Drug: Everolimus and mycophenolate sodium']}], 'interventions': [{'name': 'Everolimus and mycophenolate sodium', 'type': 'DRUG', 'description': 'Everolimus tablets, 1.5mg/day bid, dosage adjusted to plasma levels Mycophenolate sodium, 720mg/day bid Duration: Mycophenolate tapering starts at day 56 after stem cell transplantation Everolimus tapering starts at day 100 after stem cell transplantation if no GvHD evident', 'armGroupLabels': ['Everolimus and mycophenolate sodium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79104', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Reinhard Marks, MD', 'role': 'CONTACT', 'email': 'reinhard.marks@uniklinik-freiburg.de', 'phone': '49-761-270', 'phoneExt': '3278'}, {'name': 'Reinhard Marks, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juergen Finke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center, Division Hematology/Oncology', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'centralContacts': [{'name': 'Reinhard Marks, MD', 'role': 'CONTACT', 'email': 'reinhard.marks@uniklinik-freiburg.de', 'phone': '49-761-270-', 'phoneExt': '3278'}, {'name': 'Juergen Finke, MD', 'role': 'CONTACT', 'email': 'juergen.finke@uniklinik-freiburg.de', 'phone': '49-761-270-', 'phoneExt': '3408'}], 'overallOfficials': [{'name': 'Juergen Finke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Freiburg, Div. Hematology/Oncology'}, {'name': 'Reinhard Marks, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Center Freiburg, Div. Hematology/Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Jürgen Finke', 'oldOrganization': 'University Hospital Freiburg'}}}}