Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)
NCT ID: NCT01118234
Last Updated: 2020-01-09
Study Results
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Basic Information
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COMPLETED
PHASE3
256 participants
INTERVENTIONAL
2009-12-31
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rituximab
Treatment with Rituximab 375 mg/m² every 3 months for 24 months
Rituximab
Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation
Observation
Observation for 24 months
No interventions assigned to this group
Interventions
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Rituximab
Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation
Eligibility Criteria
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Inclusion Criteria
* Age \>18
* ECOG performance status 0-2
* Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
* Patient must be in complete remission or partial remission after an induction treatment containing rituximab
* ANC (absolute neutrophil count) \> 1,0 x 10e9 /L
* Life expectancy \> 6 months
* Patient´s written informed consent
* Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter
Exclusion Criteria
* Significantly reduced organ functions and bone marrow dysfunction not due to CLL
* creatinine clearance of below 30mL/min
* Patients with a history of other malignancies within 2 years prior to study entry
* Patients with a history of severe cardiac disease
* Other known comorbidity with the potential to dominate survival
* Transformation to aggressive B-cell malignancy
* Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
* Medical condition requiring prolonged (\> 1 month) use of oral corticosteroids
* Pregnant or breast feeding women
* Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Arbeitsgemeinschaft medikamentoese Tumortherapie
OTHER
Responsible Party
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Principal Investigators
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Richard Greil, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Arbeitsgemeinschaft medikamentoese Tumortherapie
Locations
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Landesklinikum Krems, Hämato-onkologisches Service
Krems, Lower Austria, Austria
A.ö. Bezirkskrankenhaus Hall in Tirol, Innere Medizin / Hämato - Onkologie
Hall in Tirol, Tyrol, Austria
Universitätsklinik Innsbruck, Innere MEdizin IV / Hämato-Onkologie
Innsbruck, Tyrol, Austria
A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie
Kufstein, Tyrol, Austria
AKH Linz, Department für Innere Medizin 3
Linz, Upper Austria, Austria
Landeskrankenhaus Steyr, Innere Medizin, Hämatologie, Onkologie
Steyr, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV
Wels, Upper Austria, Austria
LKH Feldkirch, Interne E
Feldkirch, Vorarlberg, Austria
Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin
Salzburg, , Austria
AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie
Vienna, , Austria
Hanusch Krankenhaus, 3. Med. Abtlg.
Vienna, , Austria
FN Brno
Brno, , Czechia
FN Hradec Kralove
Hradec Králové, , Czechia
FN Olomouc
Olomouc, , Czechia
FN Kralovske Vinohrady
Prague, , Czechia
VFN Praha 2
Prague, , Czechia
F.D. Rossevelt hospital
Banská Bystrica, , Slovakia
Narodny onkologicky ustav
Bratislava, , Slovakia
FNsP sv. Cyrila a Metoda
Bratislava, , Slovakia
FNsP L.Pasteura
Košice, , Slovakia
Martinska fakultna nemocnica
Martin, , Slovakia
FNsP J.A. Reimana
Prešov, , Slovakia
Countries
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References
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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.
Other Identifiers
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Mabtenance
Identifier Type: -
Identifier Source: org_study_id
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