Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT00521560
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2007-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Zevalin and Simultaneous Application of BEAM High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation in Refractory and Relapsed Aggressive Non-Hodgkin Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C422802', 'term': 'ibritumomab tiuxetan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-13', 'studyFirstSubmitDate': '2007-08-27', 'studyFirstSubmitQcDate': '2007-08-27', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome variable is the highest achievable dose level of 90Y-Zevalin administered immediately before BEAM high-dose therapy and followed by autologous stem cell transplantation.', 'timeFrame': '3 Year'}], 'secondaryOutcomes': [{'measure': 'Treatment related mortality (TRM), freedom from progression (FFP), Survival (OS), progression free survival (PFS) grade III -IV toxicity (CTC) on lung, liver and kidney', 'timeFrame': '3 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['High-Dose Radio-Immuno- and Chemotherapy', 'stem cell transplantation', '90Y-Ibritumomab-Tiuxetan'], 'conditions': ['Primary Non-Hodgkin-Lymphoma', 'Refractory Non-Hodgkin-Lymphoma', "CD20+ Aggressive Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 18 - 65 years\n* Risk group: 1) Progression on primary therapy 2) Initial or subsequent relapse\n* Histology: Diagnosis of relapsed aggressive non-Hodgkin lymphoma, whenever possible confirmed by an excision biopsy of a lymph node or by a sufficiently large biopsy of an extranodal site if no lymph node lesion is present. The expression of the CD20 antigen must be demonstrated in the primary lesion or in the relapse. Specifically, the following entities can be treated in this study:\n\nB-NHL:\n\nGrade III B follicular lymphoma Diffuse B-cell lymphoma centroblastic immunoblastic plasmoblastic anaplastic-large-cell T-cell rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Mantle cell lymphoma, blastoid Variants of Burkitt's lymphoma Aggressive marginal zone lymphoma (monocytoid)\n\n* General condition: General condition ECOG 0-3 (Karnofsky: 40 - 100 %); for definition see Annex 14.10\n* Presence of declaration of participation of the center and the patient's written consent form\n\nExclusion Criteria:\n\n* Prior mediastinal or extensive abdominal irradiation\n* Prior high-dose therapy and autologous stem cell transplantation\n* Impairment of renal function (creatinine \\> 2.5 mg/dL, creatinine clearance \\< 20 mL/min)\n* Impairment of hepatic function (bilirubin \\> 2.0 mg/dL, cholinesterase \\[CHE\\] \\< 2000 U/L)\n* Impairment of pulmonary function (transfer lung factor for CO \\[TLCO\\] \\< 50 %, forced expiratory volume in 1 sec \\[FEV1\\] \\< 60 %, vital capacity \\[VC\\] \\< 60 %)\n* Relevant deterioration of the above organ functions on salvage therapy\n* Failure of stem cell mobilization\n* Active viral hepatitis\n* HIV infection\n* Other active or not conclusively curatively treated malignoma\n* Severe concomitant psychiatric illness or suspected lack of patient compliance\n* Pregnancy or unreliable contraception\n* Highly dynamic progress of lymphoma (lactate dehydrogenase \\[LDH\\] \\> 1.5 x upper limit of normal \\[ULN\\]) after salvage therapy immediately prior to radioimmunotherapy"}, 'identificationModule': {'nctId': 'NCT00521560', 'acronym': 'escZ-BEAM', 'briefTitle': 'A Study of Zevalin and Simultaneous Application of BEAM High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation in Refractory and Relapsed Aggressive Non-Hodgkin Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH'}, 'officialTitle': "Phase I/II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy With Simultaneous Application of Zevalin and BEAM Followed by Autologous Peripheral Stem Cell Transplantation in Relapsed and Refractory CD 20+ Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'DSHNHL 2004-R4'}, 'secondaryIdInfos': [{'id': 'DSHNHL 2004-R4'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Zevalin']}], 'interventions': [{'name': 'Zevalin', 'type': 'DRUG', 'otherNames': ['90Y-Ibritumomab-Tiuxetan'], 'description': 'All applications of 90Y-Ibritumomab-Tiuxetan will be preceded by rituximab infusions at a dose of 250 mg/m2 at days -21 and day -14 (DL1) or day -12 (DL2) or day -10 (DL3-5), respectively.\n\nHigh dose therapy will be given as BEAM', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Institut für anwendungsorientierte Forschung und klinische Studien (IFS GmbH)', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}], 'overallOfficials': [{'name': 'Bertram Glass, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'German Society of Cancer e.V.'}, {'name': 'Martin Gramatzki, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Städtisches Krankenhaus Kiel, II. Med. Uniklinik, Kiel, Germany'}, {'name': 'Mattias Witzens Harig, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abteilung Innere Medizin V, Hämatologie, Onkologie, Heidelberg, Germany'}, {'name': 'Bernd Hertenstein, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Bremen-Mitte gGmbH, Medizinische Klinik I, Bremen, Germany'}, {'name': 'Georg Heß, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'III Med., Schwerpunkt Hämatologie / Onkologie, Mainz, Germany'}, {'name': 'Dorothea Kofahl-Krause, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MHH, Hämatologie, Hämostaseologie und Onkologie, Hannover, Germany'}, {'name': 'Norbert Schmitz, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asklepios Klinik St. Georg, Hämatologische Abt., Hamburg, Germany'}, {'name': 'Jörg Schubert, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätskliniken d. Saarlandes, Med. I, Homburg/Saar, Germany'}, {'name': 'Lutz Uharek Uharek, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Campus Benjamin Franklin, Med. III, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}