Realgar-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
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Informed consent
* New diagnosis of APL by cytomorphology, confirmed for molecular analysis
* Age ≥18 and ≤75 years
* Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l)
* Serum creatinine ≤ 3.0 mg/dl (≤ 260 μmol/l)
* Women must meet at least one of the following criteria to be eligible for inclusion in the study: Postmenopausal (12 months of amenorrhea or 6 months of amenorrhea with serum FSH \> 40 U/ml); After undergoing hysterectomy or bilateral oophorectomy; Continuous and correct use of a contraceptive method with a Pearl Index \<1% (e.g., implants, oral contraceptives, intrauterine devices); Sexual abstinence; Vasectomy of sexual partner.
Exclusion Criteria:
* High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician;
* Age \<18 or \>75 years
* Other active malignancy at the time of study entry
* Lack of diagnostic confirmation at the genetic level
* Significant arrhythmias, ECG abnormalities, or neuropathy: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia; Clinically significant resting bradycardia (\<50 beats per minute); QTc \> 500 ms on ECG screening for both sexes; Right bundle branch block with left anterior hemiblock or bifascicular block
* High-risk patients with other cardiac contraindications for intensive chemotherapy (LVEF \< 50%)
* Uncontrolled and potentially fatal infections
* Severe uncontrolled pulmonary or cardiac disease
* Severe hepatic or renal dysfunction
* Known HIV and/or hepatitis C infection
* Pregnant or breastfeeding women
* Allergy to the study drug or excipients in the study medication
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or the assessment of study outcomes
* Use of other investigational drugs at the time of enrollment or within 30 days before study entry.
Primary outcome measure(s)
Overall Survival — 2 years This endpoint includes death from any cause, including early death, death due to disease progression, or any death occurring after achieving complete remission.
Trial sites (1)
Facility
City
Region
Status
Instituto do Cancer do Estado de Sao Paulo
São Paulo
São Paulo
Recruiting
More Instituto do Cancer do Estado de São Paulo trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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