Skip to main content

Table 3 Inclusion and exclusion criteria

From: Rationale and design of the 2 by 2 factorial design GnG-trial: a randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare double-blinded intensive postremission therapy with or without glasdegib in older patients with newly diagnosed AML

Category Inclusion Exclusion
Population characteristics - Patients with newly diagnosed acute myeloid leukemia according to the 2016 WHO classification.
- Genetic and immunophenotypic assessment in one of the central laboratories.
- Age ≥ 60 years, no upper age limit.
- ECOG performance status ≤2.
- Effective contraception method.
- AML with PML-RARA or BCR-ABL1.
- Patients with known active CNS leukemia.
- Pregnancy and lactation.
- Known or suspected active alcohol or drug abuse.
- Known positivity for HIV, active HBV, HCV, or hepatitis A infection.
- Severe neurologic or psychiatric disorder interfering with ability of giving informed consent.
Prior therapies - No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis (≤7 days). - Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.
Comorbidities   - Inadequate renal function.
- Inadequate liver function.
- Known liver cirrhosis.
- History of sinusoidal. Obstruction syndrome.
- Uncontrolled hypertension.
- Severe obstructive restrictive. ventilation disorder.
- Myocardial infarction.
- Congenital long QT syndrome.
- Torsades de pointes.
- Arrhythmias (including sustained ventricular tachyarrhythmia).
- Right or left bundle branch block and bifascicular block.
- Unstable angina.
- Coronary/peripheral artery bypass graft.
- Symptomatic congestive heart failure (NYHA III/IV).
- Cerebrovascular accident.
- Transient ischemic attack.
- Symptomatic pulmonary. embolism.
- Bradycardia defined as < 50 bpms.
- QTc interval > 470 msec.
- Uncontrolled infection.
- Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy.
- Patients with a “currently active” second malignancy other than non-melanoma skin cancer.
Others - Signed written informed consent.
- Ability of the patient to understand character and consequences of the clinical trial.
- No consent for biobanking.
- History of hypersensitivity to the investigational medicinal product or to any drug with a similar chemical structure.
- Participation in a clinical study involving an investigational drug.
  1. Abbreviations: AML acute myeloid leukemia, CNS central nervous system, ECOG Eastern Cooperative Oncology Group, NYHA New York Heart Association