In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. The primary endpoint will concern the efficacy of lenalidomide in patients with CMML according to the WHO diagnostic criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Dose escalation 5mg - 10mg - 15mg - 20mg in cohorts of three patients The first step of phase I will be 5 mg lenalidomide in a daily regimen, the next step will be 10 mg in a daily regimen, the dosis of the following steps will be increased by 5 mg each until dose limiting toxicity (DLT) is reached. Phase II will be started at the MTD (1 dose step below DLT) and will be administered in a daily regimen.
Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
Salzburg, State of Salzburg, Austria
MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie
Vienna, State of Vienna, Austria
Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie
Maximum tolerated dose (MTD)
This is a phase I/II, open-label, dose-escalation study of lenalidomide in patients with CMML. In phase I of the study the primary purpose is to determine the MTD. The purpose of phase II is to determine the response rate.
Time frame: 2 years
Number and seriousness of adverse events to evaluate safety and tolerability
For both phases (phase I and II), secondary objectives are to evaluate safety, tolerability, efficacy and analysis of molecular markers.
Time frame: 4 years
Number of patients achieving transfusion independence
Phase II
Time frame: 4 years
Progression free survival, Overall survival
Phase II
Time frame: 4 years
Patients achieving cytogenetic response
Phase II; Cytogenetic response assessment requires 20 analyzable metaphases using conventional cytogenetic techniques, FISH may be used an a supplement to follow a specifically defined cytogenetic abnormality
Time frame: 4 years
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Vienna, State of Vienna, Austria
Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie
Graz, Styria, Austria
Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie
Innsbruck, Tyrol, Austria
Krankenhaus d. Barmherzigen Schwestern Linz, Interne I
Linz, Upper Austria, Austria
Krankenhaus der Elisabethinen Linz GmbH, 1. Interne
Linz, Upper Austria, Austria
AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
Wels, Upper Austria, Austria
LKH Feldkirch, Interne E
Feldkirch, Vorarlberg, Austria