Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL
15 patients around the world
Available in Mexico
The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic plasma
concentrations sufficient to achieve therapeutic efficacy with doses of 25mg/m2/day. ATO
alone demonstrated considerable effectiveness in this disease. More recently, an attenuated
regimen has been proven to be effective in inducing similar remission rates and achieving
prolonged survival, also demonstrating a reduction in associated toxicities, mainly hepatic
and cardiac when using this new scheme.
The investigators will conduct a phase 1/2, non-randomized, single center, non-comparative
clinical trial to demonstrate the effectiveness of combined therapy of low-dose ATRA plus
attenuated dose ATO which is accessible to a population with limited resources while
maintaining acceptable efficacy and safety.
Hospital Universitario Dr. Jose E. Gonzalez
1Research sites
15Patients around the world
This study is for people with
Leukemia
Acute myeloid leukemia
Promyelocytic leukemia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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
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)
Sites
Hospital Universitario Dr. José Eleuterio González
Recruiting
Av. Dr. José Eleuterio González, Mitras Centro, 64460 Monterrey, N.L., Mexico
StudyATO
SponsorHospital Universitario Dr. Jose E. Gonzalez