Online-Material

The primary endpoint of this phase I study was to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of escalating doses of lenalidomide given in combination with fixed doses of R-CHOP in elderly patients with untreated DLBCL. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Bethesda, MD: National Cancer Institute; 2003). Secondary endpoints included complete remission CR and overall response rate. Safety evaluations included adverse events, vital signs, laboratory safety assessments (hematology, clinical chemistry). DLT was defined as the maximum dose inducing any grade ≥3 non-hematologic toxicity or a delay >15 days of a planned cycle date observed during the first two cycles. Due to the occurrence of a grade 3 motor neurotoxicity in the third LR-CHOP21 course of the fourth enrolled patient [ID patient 0301], a protocol amendment in March 2008 stated to assess DLTs evaluation during the first three cycles.