Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL.

• Status: Recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

Summary

ATRA is the standard of care for all patients with APL. The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic efficacy with doses of 25mg/m2/day. ATO demonstrated considerable effectiveness in this disease. More recently, an attenuated regimen has been proven to be effective. In this study we intent to demonstrate the effectiveness of combined therapy of low-dose ATRA plus attenuated dose ATO.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Treatments: Arsenic Trioxide; Tretinoin

Criteria

Inclusion Criteria:

• Age >18 years

• Both genders

• new diagnosis of APL

• Diagnosis of relapsed APL who have not been previously treated with ATO

• Morphological diagnosis of APL confirmed by PCR or FISH

Exclusion Criteria:

• Poor functional status (ECOG>2)

• Organic dysfunction (Marshall score ≥2)

• Pregnancy

• Heart failure (NYHA III or IV)

• Renal failure (GFR <30 ml/min/1.72m2)

• History of ventricular arrhythmias or uncontrolled arrhythmias

• Acute myocardial infarction, unstable angina, or stable angina in the last six months

• Uncontrolled active infection

• Liver disease (Child-Pugh C)