Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT01456351
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2011-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], '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': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2011-10-11', 'studyFirstSubmitQcDate': '2011-10-19', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Free Survival', 'timeFrame': 'Observation till event or death, minimum 1 year', 'description': 'From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year'}], 'secondaryOutcomes': [{'measure': 'Remission Rates', 'timeFrame': 'Observation till event or death, minimum 1 year', 'description': 'From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Event free survival', 'Remission rates', 'Toxicity', 'Overall survival', 'Efficiency costs', 'Recurrent low grade'], 'conditions': ["Non-Hodgkin's Lymphoma", 'Mantle Cell Lymphoma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '58. Rummel MJ et al. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab In Patients with Relapsed Follicular, Indolent and Mantle Cell Lymphomas - Final Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany) Blood 2010; 116: 856'}, {'type': 'BACKGROUND', 'citation': '81. Rummel MJ et al. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab in Patients with Relapsed Follicular, Indolent, or Mantle Cell Lymphomas - 8-Year Follow-up Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany) Blood 2014; 124:145.'}, {'pmid': '26655425', 'type': 'BACKGROUND', 'citation': 'Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study Group Indolent Lymphomas. Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. doi: 10.1016/S1470-2045(15)00447-7. Epub 2015 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:\n* Follicular lymphoma grade 1 and 2\n* Immunocytoma and lymphoplasmocytic lymphoma\n* Marginal zone lymphoma, nodal and generalised\n* Mantle cell lymphoma\n* lymphocytic lymphoma (CLL without leucaemic characteristics)\n* non-specified/classified lymphomas of low malignancy\n* Recurrent disease (remission duration minimum 3 months), independent of type or quantity of prior therapies, except of Rituximab containing regimens, or if remission duration is \\> 1 year after Rituximab containing regimen, or refractory to prior therapy (progression under therapy or during 3 months after completion), except refractory disease to purin analogs or Bendamustine\n* Need for therapy, except mantle cell lymphomas\n* Stadium II (bulky disease, 7.5 cm), II or IV\n* Written informed consent\n* Performance status WHO 0-2\n* Histology not older than 6 months\n\nExclusion Criteria:\n\n* Patients not establishing all above mentioned prerequisites\n* Option of a primary, potentially curative radiation therapy\n* Patients refractory to Rituximab containing regimens\n* Comorbidities excluding a study conform therapy:\n\nheart attack during the last 6 months severe, medicinal not adjustable hypertonia severe functional defects of the heart (NYHA III or IV) lung (WHO grade III or IV) liver or kidney (creatinine \\> 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma\n\n* Active auto immunohemolytic anemia (AIHA)\n* HIV positive patients\n* Active hepatitis infection\n* Severe psychiatric diseases\n* No compliance or non-compliance to be expected\n* Pregnant or breast feeding women\n* Anamnestic malignancies or secondary malignancies, not proven\n* Cured/curable by surgery'}, 'identificationModule': {'nctId': 'NCT01456351', 'briefTitle': 'Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas', 'orgStudyIdInfo': {'id': 'NHL 2-2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bendamustine plus Rituximab', 'description': 'Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w', 'interventionNames': ['Drug: Bendamustine plus Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fludarabine plus Rituximab', 'description': 'Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w', 'interventionNames': ['Drug: Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w']}], 'interventions': [{'name': 'Bendamustine plus Rituximab', 'type': 'DRUG', 'description': 'Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles', 'armGroupLabels': ['Bendamustine plus Rituximab']}, {'name': 'Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w', 'type': 'DRUG', 'description': 'Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles', 'armGroupLabels': ['Fludarabine plus Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'StiL Head Office; Justus-Liebig-University', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Mathias Rummel', 'investigatorFullName': 'Jurgen Barth', 'investigatorAffiliation': 'University of Giessen'}}}}