Trial design and patients
PD, death, primary progressive disease
ADVERSE EVENTS, MAY, DISEASE, ADVERSE EVENT
Between 11 February 2020 and 2 January 2023, 65 patients were screened, of which 59 were enrolled. Of those, two did not receive study medication owing to death (one patient) and withdrawal of consent (one patient) and nine discontinued study treatment within the first two cycles owing to primary progressive disease (three patients), death (one patient), adverse events (four patients) and non-compliance (one patient). According to the study protocol, 48 patients who received at least two cycles of study treatment, including at least one administered dose in cycle three, comprised the analysis population (Fig. CONSORT diagram of RT1. PD, progressive disease; AE, adverse event.The median age was 67 (range 45–82) years, 29 (60.4%) patients were male and 19 (39.6%) were female (Table Baseline patient characteristicsCytogenetics, Adverse eventsWith a data cutoff of 2 May 2023, 19 patients were still under ongoing treatment (Fig. 