Withdrawal of patients
toxicity
A patient must be withdrawn from the trial (i) at any time at the patient’s own request, (ii) after salvage therapy if the patient fails to obtain CR/Cri/CRh, (iii) at any time if unacceptable toxicity necessitating cessation of treatment is observed, (iv) at any time if there are changes in the medical status of the patient that compromise the patient’s safety or if the investigator considers that the withdrawal is in the patient’s best interest, (v) in case of pregnancy, (vi) at any time a patient’s protocol compliance turns out insufficient, and (vii) if patient is lost to follow-up.If any of the aforementioned criteria are met, and patients agree to follow-up, previous unresolved AEs will continuously be followed. If cases iii and iv are met we will continue with the follow-up of the patient until the end of the study. However, if the patient withdraws from the trial and also from consent for disclosure of future information (e.g., follow-up visits), further data collection is prohibited.