Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-09 @ 11:11 PM
Study NCT ID:
NCT00682305
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2008-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}], 'ancestors': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-12', 'studyFirstSubmitDate': '2008-05-16', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT', 'timeFrame': '1 year after SCT'}], 'secondaryOutcomes': [{'measure': '*Incidence of aGvHD on day +100/ cGvHD at 1 and 2 yrs after SCT/ relapse at 2 yrs after SCT *Toxicity *Disease-free survival at 2 yrs after SCT *overall survival at 2 yrs. after SCT', 'timeFrame': '2 years after transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Lymphoblastic Leukemia', 'Hematopoeitic Stem Cell Transplantation'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '26367236', 'type': 'DERIVED', 'citation': 'Kroger N, Bornhauser M, Stelljes M, Pichlmeier U, Trenschel R, Schmid C, Arnold R, Martin H, Heinzelmann M, Wolschke C, Meyer RG, Bethge W, Kobbe G, Ayuk F, Gokbuget N, Holzer D, Zander A, Beelen D. Allogeneic stem cell transplantation after conditioning with treosulfan, etoposide and cyclophosphamide for patients with ALL: a phase II-study on behalf of the German Cooperative Transplant Study Group and ALL Study Group (GMALL). Bone Marrow Transplant. 2015 Dec;50(12):1503-7. doi: 10.1038/bmt.2015.202. Epub 2015 Sep 14.'}]}, 'descriptionModule': {'briefSummary': 'The present study is a multicenter, prospective phase II-study investigating the combination of treosulfan, etoposide, and cyclophosphamide as conditioning regimen for patients with acute lymphoblastic leukemia who are not eligible for a TBI-containing regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Acute lymphoblastic leukemia in first or subsequent complete remission\n* Indication for allogeneic stem cell transplantation according to the actual protocol of the German Acute Lymphoblastic Leukemia Study Group\n* Patient's age: 18-65 years\n* HLA-identical or compatible related or unrelated donor (HLA-A, HLA-B, HLA-C, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed)\n* Not eligible for total-body irradiation due to one of the following reasons:\n\n * prior radiation of the spine \\> 30 Gy\n * prior radiation of the mediastinum \\> 30 Gy\n * severe pulmonary infection during induction chemotherapy\n * DLCO \\> 50%\n* Patient's wishing to avoid total-body irradiation as conditioning regimen\n* Patient's written informed consent\n* Women and men capable of reproduction must agree to use highly effective methods of contraception until six months after treatment termination. For men: vasectomy, sexual abstinence, or partner is using hormonal IUD, implants, injectables, oral hormonal contraceptives or is surgically sterilized. For women: hormonal IUD, implants, injectables, sexual abstinence, surgical sterilization, vasectomised partner\n\nExclusion Criteria:\n\n* No complete remission at time of registration\n* Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as\n\n * total bilirubin, SGPT or SGOT \\> 3 times upper the normal level\n * Left ventricular ejection fraction \\< 30%\n * Creatinine clearance \\< 30 ml/min\n * DLCO \\< 35% and/ or receiving supplementary continuous oxygen\n* Positive serology HIV\n* Pregnant or lactating women\n* Severe florid infection\n* Experienced hypersensitivity against cyclophosphamid, etoposide, or treosulfan\n* Cystitis\n* Obstructive renal function\n* Participation in any other clinical drug trial\n* Serious psychiatric or psychological disorders\n* Progressive invasive fungal infection at time of registration"}, 'identificationModule': {'nctId': 'NCT00682305', 'briefTitle': 'Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Allogeneic Stem Cell Transplantation With Treosulfan, VP-16 and Cyclophosphamide for Patients With Acute Lymphoblastic Leukemia (ALL) Not Eligible for TBI-containing Conditioning Regimen: A Phase II-study', 'orgStudyIdInfo': {'id': 'TreoALL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single-Arm', 'description': 'Single-Arm', 'interventionNames': ['Procedure: Hematopoietic stem cell transplantation']}], 'interventions': [{'name': 'Hematopoietic stem cell transplantation', 'type': 'PROCEDURE', 'description': 'conditioning regimen:\n\n* day -7: 12g/m\\^2 Treosulfan\n* day -6: 12g/m\\^2 Treosulfan\n* day -5: 12g/m\\^2 Treosulfan\n* day -4: 30mg/kg BW Etoposide\n* day -3: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide\n* day -2: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide\n* day -1: 20mg/kg ATG Fresenius (OPTIONAL)\n* day 0: SCT', 'armGroupLabels': ['Single-Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Nicolaus Kroeger, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}