Last updated 2 years ago

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
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