The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.
This is a non-randomized, multicenter, open-label, single-arm Phase I/II study in patients with previously untreated CD20-positive CLL. Phase I of the study will evaluate the maximal tolerated lenalidomide dose level in combination with fludarabine/rituximab chemoimmunotherapy in 10 patients. Phase II will determine efficacy using the combination in the previously defined maximal tolerated dose. Both phases will be followed by a maintenance phase evaluating the tolerability and possibility to further improve response quality.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Dose escalation stage: starting dose 2.5mg/d, dose escalation via 5/10/15/20/25 mg/d every 28 days if no dose-limiting toxicity. During maintenance stage dosing on days 1-28 for max. 6 months at maximum tolerated dose reached during dose escalation stage.
25 mg/m2 i.v. d1-3 or 40 mg/m2 po d1-3 every 28 days for 6 cycles during dose escalation stage.
Dose escalation stage: 375 mg/m2 i.v. d4 Cycle 1, 500 mg/m2 i.v. d1 Cycles 2-6. Maintenance stage: 375 mg/m2 i.v. at 2/4/6 months after end of escalation stage.
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
Innsbruck, Tyrol, Austria
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, Austria
Krankenhaus der Elisabethinen Linz GmbH
Linz, Austria
Lenalidomide Maximum Tolerated Dose
Time frame: Dose escalation stage
Safety profile of Lenalidomide/Fludarabine/Rituximab treatment
Time frame: Study Duration
Safety Profile of Lenalidomide/Rituximab
Time frame: Study duration
Response rate for Lenalidomide/Fludarabine/Rituximab combination treatment
Time frame: Dose escalation stage
Response rate for Lenalidomide/Rituximab combination therapy
Time frame: Study Duration
Response rate by 4-colour flow cytometric MRD analysis
Time frame: Study Duration
Changes in Quality of Life scores
Time frame: Study Duration
Risk factors and clonal evolution
Time frame: Study Duration
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Krankenhaus der Stadt Linz
Linz, Austria
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria