RecruitingPhase 2NCT06982274

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

Combination of Oral Arsenic With ATRA and Minimal-Dose Chemotherapy for Newly Diagnosed Patients With Acute Promyelocytic Leukemia: a Study by the International Consortium on APL


Sponsor

Instituto do Cancer do Estado de São Paulo

Enrollment

115 participants

Start Date

Oct 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

It is a non-randomized, multicenter, prospective study, aiming to treat patients with newly diagnosed acute promyelocytic leukemia with a combination of oral arsenic and atra, with low dose chemotherapy for those with high-risk disease (white blood cell count above 10x10a9/L). The primary objective is to assess the 2-year overall survival (OS) in these patients, comparing with the historical control group of patients treated with ATRA/chemotherapy according to the IC-APL 2006 protocol.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an oral (pill-form) arsenic treatment combined with ATRA (a vitamin A derivative) for newly diagnosed acute promyelocytic leukemia (APL), a specific subtype of blood cancer. Traditional arsenic treatment is given by IV infusion; this study tests whether the oral version works just as well and is more convenient. **You may be eligible if...** - You are between 18 and 75 years old - You have just been diagnosed with acute promyelocytic leukemia (APL), confirmed by genetic testing - Your liver and kidney function are within acceptable limits - Women must use effective contraception or be post-menopausal/surgically sterile **You may NOT be eligible if...** - You are a high-risk patient where your doctor feels chemotherapy is needed - You are younger than 18 or older than 75 - You have significant heart rhythm problems or a long QT interval on your ECG - You have another active cancer at the time of diagnosis - Genetic confirmation of APL is lacking 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

DRUGRealgar-Indigo Naturalis Formulation

Oral Arsenic (Realgar-Indigo Naturalis Formulation) plus ATRA for low-intermediate risk APL pts, combined with daunorubicin for high-risk during induction


Locations(1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, Brazil

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NCT06982274


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