Clinical Research Directory

Inclusion Criteria: * Informed consent * New diagnosis of APL by cytomorphology, confirmed for molecular analysis * Age ≥18 and ≤75 years * Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l) * Serum creatinine ≤ 3.0 mg/dl (≤ 260 μmol/l) * Women must meet at least one of the following criteria to be eligible for inclusion in the study: Postmenopausal (12 months of amenorrhea or 6 months of amenorrhea with serum FSH \> 40 U/ml); After undergoing hysterectomy or bilateral oophorectomy; Continuous and correct use of a contraceptive method with a Pearl Index \<1% (e.g., implants, oral contraceptives, intrauterine devices); Sexual abstinence; Vasectomy of sexual partner. Exclusion Criteria: * High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician; * Age \<18 or \>75 years * Other active malignancy at the time of study entry * Lack of diagnostic confirmation at the genetic level * Significant arrhythmias, ECG abnormalities, or neuropathy: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia; Clinically significant resting bradycardia (\<50 beats per minute); QTc \> 500 ms on ECG screening for both sexes; Right bundle branch block with left anterior hemiblock or bifascicular block * High-risk patients with other cardiac contraindications for intensive chemotherapy (LVEF \< 50%) * Uncontrolled and potentially fatal infections * Severe uncontrolled pulmonary or cardiac disease * Severe hepatic or renal dysfunction * Known HIV and/or hepatitis C infection * Pregnant or breastfeeding women * Allergy to the study drug or excipients in the study medication * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or the assessment of study outcomes * Use of other investigational drugs at the time of enrollment or within 30 days before study entry.