Table 1 Key patient eligibility criteria for the VICTOR trial

• Diagnosis of CD33 positive AML

• Age ≥ 60 years (prior to the interim analyses performed after enrolment of 50 and 100 patients)

• Genotype NPM1^mut FLT3 ITD^neg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted)

• Considered fit for intensive chemotherapy with anthracyclines by treating physician

• Eastern Cooperative Oncology Group (ECOG) performance status 0–2

• Serum creatinine ≤ 1.5 × ULN (upper limit of normal)

• Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN and bilirubin ≤ 2 × ULN

• Able to provide written informed consent

Exclusion Criteria

• Previous chemotherapy for AML or any antecedent haematological condition, with the exception of hydroxycarbamide to control white blood cell count

• Other active malignancy requiring treatment

• Newly diagnosed or uncontrolled HIV or hepatitis B or C infection. Patients with known chronic infections may enrol if the last two tests for viral load have been negative and their current therapy does not include a protease inhibitor or a non-nucleoside reverse-transcriptase inhibitor

• Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)

• Females of childbearing potential, and their partners, not willing to use adequate contraception during and for up to 7 months after treatment

• Patients who are unable to swallow tablets whole

• Known hypersensitivity to any of the investigational medicinal products

• Patients known to require vaccination with a live vaccine during the treatment period