RecruitingNCT04897490

RWE of 1st Line Treatment With ATO/ATRA for Adult APL

Real World Evidence of First Line Treatment With Arsenic Trioxide Plus All Trans Retinoic Acid in Adult Patients With Acute Promyelocytic Leukemia


Sponsor

Grupo Argentino de Tratamiento de la Leucemia Aguda

Enrollment

50 participants

Start Date

Mar 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of acute promyelocytic leukemia (APL) patients in the first line with arsenic trioxide and all trans retinoic acid (ATO/ATRA) based regimens in Argentina.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world evidence study collects data from adults with acute promyelocytic leukemia (APL — a specific type of blood cancer) who are being treated with the current standard combination of ATO (arsenic trioxide) and ATRA (all-trans retinoic acid). The study tracks how well this treatment works in everyday clinical settings outside of formal trials. **You may be eligible if...** - You are 18 or older - You have a new confirmed diagnosis of APL (acute promyelocytic leukemia) with the characteristic gene alteration (PML-RARα fusion) - You have not received any prior treatment for APL - You have given written informed consent **You may NOT be eligible if...** - You have another active cancer requiring treatment at the same time - You have already received treatment for APL - You have certain heart rhythm problems (long QT syndrome, QTc above 450ms, significant arrhythmias, or a specific type of heart conduction block) - You have very severe heart failure (Stage III–IV) - You have severely impaired kidney or liver function (unless caused by the leukemia itself) - You have severe psychiatric illness - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREvaluation of first line treatment with ATO/ATRA outcome

Evaluation of first line treatment with ATO/ATRA outcome (o event free survival and overall survival and toxicity) in adult patients with APL.


Locations(6)

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Instituto Privado de Hematologia y Hemoterapia

Paraná, Entre Ríos Province, Argentina

Hospital Escuela de Agudos Dr. Ramón Madariaga

Posadas, Misiones Province, Argentina

Hospital Descentralizado Dr. Guillermo Rawson

Rawson, San Juan Province, Argentina

CEMIC

CABA, Argentina

FUNDALEU

CABA, Argentina

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NCT04897490