Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT01118234
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2010-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'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': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-05-05', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '48 months', 'description': 'Clinical PFS is defined as the period from randomization until disease progression according to the NCI criteria or death due to the underlying disease.'}], 'secondaryOutcomes': [{'measure': 'MRD (minimal residual disease) progression free survival', 'timeFrame': '48 months', 'description': 'Minimal residual disease progression-free survival is defined as the period from randomization until increase of MRD levels in peripheral blood above 10-3 or, if above 10-3 before, increase of one common logarithm.'}, {'measure': 'conversion rate to MRD negative', 'timeFrame': '48 months'}, {'measure': 'median MRD levels', 'timeFrame': '48 months'}, {'measure': 'conversation rate to CR', 'timeFrame': '48 months'}, {'measure': 'effect of MRD levels on clinical PFS and OS', 'timeFrame': '48 months'}, {'measure': 'event free survival', 'timeFrame': '48 months'}, {'measure': 'time to next treatment', 'timeFrame': '48 months'}, {'measure': 'overall survival', 'timeFrame': '48 months'}, {'measure': 'Safety of Rituximab maintenance treatment in patients with CLL', 'timeFrame': '48 months', 'description': 'All grades of infections and G3/4 other clinical adverse events will be documented using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0'}, {'measure': 'benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q), IgVH mutation status, ZAP 70 and CD38 expression', 'timeFrame': '48 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CLL', 'Rituximab', 'Maintenance'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '27374465', 'type': 'DERIVED', 'citation': 'Greil R, Obrtlikova P, Smolej L, Kozak T, Steurer M, Andel J, Burgstaller S, Mikuskova E, Gercheva L, Nosslinger T, Papajik T, Ladicka M, Girschikofsky M, Hrubisko M, Jager U, Fridrik M, Pecherstorfer M, Kralikova E, Burcoveanu C, Spasov E, Petzer A, Mihaylov G, Raynov J, Oexle H, Zabernigg A, Flochova E, Palasthy S, Stehlikova O, Doubek M, Altenhofer P, Pleyer L, Melchardt T, Klingler A, Mayer J, Egle A. Rituximab maintenance versus observation alone in patients with chronic lymphocytic leukaemia who respond to first-line or second-line rituximab-containing chemoimmunotherapy: final results of the AGMT CLL-8a Mabtenance randomised trial. Lancet Haematol. 2016 Jul;3(7):e317-29. doi: 10.1016/S2352-3026(16)30045-X. Epub 2016 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* B-CLL\n* Age \\>18\n* ECOG performance status 0-2\n* Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line\n* Patient must be in complete remission or partial remission after an induction treatment containing rituximab\n* ANC (absolute neutrophil count) \\> 1,0 x 10e9 /L\n* Life expectancy \\> 6 months\n* Patient´s written informed consent\n* Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter\n\nExclusion Criteria:\n\n* Active uncontrolled bacterial, viral or fungal infection\n* Significantly reduced organ functions and bone marrow dysfunction not due to CLL\n* creatinine clearance of below 30mL/min\n* Patients with a history of other malignancies within 2 years prior to study entry\n* Patients with a history of severe cardiac disease\n* Other known comorbidity with the potential to dominate survival\n* Transformation to aggressive B-cell malignancy\n* Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs\n* Medical condition requiring prolonged (\\> 1 month) use of oral corticosteroids\n* Pregnant or breast feeding women\n* Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent'}, 'identificationModule': {'nctId': 'NCT01118234', 'briefTitle': 'Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)', 'organization': {'class': 'OTHER', 'fullName': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}, 'officialTitle': 'International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'Mabtenance'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'description': 'Treatment with Rituximab 375 mg/m² every 3 months for 24 months', 'interventionNames': ['Drug: Rituximab']}, {'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'Observation for 24 months'}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': 'Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation', 'armGroupLabels': ['Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Krems', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'Landesklinikum Krems, Hämato-onkologisches Service', 'geoPoint': {'lat': 48.40921, 'lon': 15.61415}}, {'zip': '6060', 'city': 'Hall in Tirol', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'A.ö. Bezirkskrankenhaus Hall in Tirol, Innere Medizin / Hämato - Onkologie', 'geoPoint': {'lat': 47.28333, 'lon': 11.51667}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Universitätsklinik Innsbruck, Innere MEdizin IV / Hämato-Onkologie', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '6330', 'city': 'Kufstein', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie', 'geoPoint': {'lat': 47.58333, 'lon': 12.16667}}, {'zip': '4021', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'AKH Linz, Department für Innere Medizin 3', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4400', 'city': 'Steyr', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Landeskrankenhaus Steyr, Innere Medizin, Hämatologie, Onkologie', 'geoPoint': {'lat': 48.04274, 'lon': 14.42127}}, {'zip': '4600', 'city': 'Wels', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '6807', 'city': 'Feldkirch', 'state': 'Vorarlberg', 'country': 'Austria', 'facility': 'LKH Feldkirch, Interne E', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Hanusch Krankenhaus, 3. Med. Abtlg.', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '62588', 'city': 'Brno', 'country': 'Czechia', 'facility': 'FN Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'FN Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': 'FN Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '10034', 'city': 'Prague', 'country': 'Czechia', 'facility': 'FN Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '12808', 'city': 'Prague', 'country': 'Czechia', 'facility': 'VFN Praha 2', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '97517', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'F.D. Rossevelt hospital', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '83310', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Narodny onkologicky ustav', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '85107', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'FNsP sv. Cyrila a Metoda', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '04190', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'FNsP L.Pasteura', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '03659', 'city': 'Martin', 'country': 'Slovakia', 'facility': 'Martinska fakultna nemocnica', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'zip': '08181', 'city': 'Prešov', 'country': 'Slovakia', 'facility': 'FNsP J.A. Reimana', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}], 'overallOfficials': [{'name': 'Richard Greil, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbeitsgemeinschaft medikamentoese Tumortherapie', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}