Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia

Prior treatment

• High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician;
• Use of other investigational drugs at the time of enrollment or within 30 days before study entry.

Other illness

• Other active malignancy at the time of study entry
• Uncontrolled and potentially fatal infections
• Severe uncontrolled pulmonary or cardiac disease
• Known HIV and/or hepatitis C infection
• 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

Lab values

• 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%)

Age

• Age \<18 or \>75 years

Other

• Lack of diagnostic confirmation at the genetic level
• Severe hepatic or renal dysfunction
• Pregnant or breastfeeding women

• 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.