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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | Treatment with Rituximab 375 mg/m² every 3 months for 24 months |
|
| Observation | No Intervention | Observation for 24 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | Clinical PFS is defined as the period from randomization until disease progression according to the NCI criteria or death due to the underlying disease. | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| MRD (minimal residual disease) progression free survival | 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. | 48 months |
| conversion rate to MRD negative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Greil, Prof. Dr. | Arbeitsgemeinschaft medikamentoese Tumortherapie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landesklinikum Krems, Hämato-onkologisches Service | Krems | Lower Austria | 3500 | Austria | ||
| A.ö. Bezirkskrankenhaus Hall in Tirol, Innere Medizin / Hämato - Onkologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27374465 | Derived | 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. |
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| 48 months |
| median MRD levels | 48 months |
| conversation rate to CR | 48 months |
| effect of MRD levels on clinical PFS and OS | 48 months |
| event free survival | 48 months |
| time to next treatment | 48 months |
| overall survival | 48 months |
| Safety of Rituximab maintenance treatment in patients with CLL | 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 | 48 months |
| benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q), IgVH mutation status, ZAP 70 and CD38 expression | 48 months |
| Hall in Tirol |
| Tyrol |
| 6060 |
| Austria |
| Universitätsklinik Innsbruck, Innere MEdizin IV / Hämato-Onkologie | Innsbruck | Tyrol | 6020 | Austria |
| A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie | Kufstein | Tyrol | 6330 | Austria |
| AKH Linz, Department für Innere Medizin 3 | Linz | Upper Austria | 4021 | Austria |
| Landeskrankenhaus Steyr, Innere Medizin, Hämatologie, Onkologie | Steyr | Upper Austria | 4400 | Austria |
| Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV | Wels | Upper Austria | 4600 | Austria |
| LKH Feldkirch, Interne E | Feldkirch | Vorarlberg | 6807 | Austria |
| Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin | Salzburg | 5020 | Austria |
| AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie | Vienna | 1090 | Austria |
| Hanusch Krankenhaus, 3. Med. Abtlg. | Vienna | 1140 | Austria |
| FN Brno | Brno | 62588 | Czechia |
| FN Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| FN Olomouc | Olomouc | Czechia |
| FN Kralovske Vinohrady | Prague | 10034 | Czechia |
| VFN Praha 2 | Prague | 12808 | Czechia |
| F.D. Rossevelt hospital | Banská Bystrica | 97517 | Slovakia |
| Narodny onkologicky ustav | Bratislava | 83310 | Slovakia |
| FNsP sv. Cyrila a Metoda | Bratislava | 85107 | Slovakia |
| FNsP L.Pasteura | Košice | 04190 | Slovakia |
| Martinska fakultna nemocnica | Martin | 03659 | Slovakia |
| FNsP J.A. Reimana | Prešov | 08181 | Slovakia |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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