Additional study procedures during salvage, maintenance therapy, and follow-up
MEASURABLE RESIDUAL DISEASE
Patients undergo efficacy and safety assessments, including monitoring of Measurable Residual Disease (MRD), bone marrow specimen collection, and blood and urine sampling before receiving the study drug and at the end of each treatment cycle. During maintenance and follow-up, trial-specific samples are taken every third month. Routine examinations (physical signs, blood values, etc.) are taken at least weekly during treatment. Patient-reported outcome questionnaires are to be completed before treatment and after the end of each treatment cycle, and additionally in 3-month intervals during maintenance and follow-up. AEs are recorded during every visit. Strong CYP3A4 inhibitors should be avoided, and strong or moderate CYP3A4 inducers must not be used.