Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide Followed by Rituximab/Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Concomitant Evaluation of Safety and Efficacy.
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Lenalidomide Maximum Tolerated Dose
Dose escalation stage
Richard Greil, Prof. Dr.
Universitaetsklinik f. Innere Medizin III, Universitaetsklinikum der PMU, Salzburg
Austria: Agency for Health and Food Safety