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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation
Landesklinikum Krems, Hämato-onkologisches Service
Krems, Lower Austria, Austria
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.
Time frame: 48 months
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.
Time frame: 48 months
conversion rate to MRD negative
Time frame: 48 months
median MRD levels
Time frame: 48 months
conversation rate to CR
Time frame: 48 months
effect of MRD levels on clinical PFS and OS
Time frame: 48 months
event free survival
Time frame: 48 months
time to next treatment
Time frame: 48 months
overall survival
Time frame: 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
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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
...and 12 more locations
Time frame: 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
Time frame: 48 months