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

Launched by INSTITUTO DO CANCER DO ESTADO DE SÃO PAULO · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients who have just been diagnosed with Acute Promyelocytic Leukemia (APL), a type of blood cancer. The study is testing a combination of oral arsenic, a medication called ATRA, and low-dose chemotherapy, especially for patients who have a higher risk due to their white blood cell count. The main goal is to see if this new combination can help patients live longer over a two-year period compared to previous treatments.

To be eligible for the trial, participants need to be between 18 and 75 years old, have a confirmed diagnosis of APL, and meet certain health requirements, such as having normal liver and kidney function. Women must also meet specific criteria regarding pregnancy and contraception. Those who have other serious health issues or certain heart conditions may not be able to join. If someone participates, they can expect close monitoring and care throughout the study, contributing to important research that could improve treatment for future APL patients.

Gender

ALL

Eligibility criteria

• 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.