Oral Arsenic With ATRA for Newly Diagnosed Acute Promyelocytic Leukemia
Tests oral arsenic with ATRA in adults newly diagnosed with acute promyelocytic leukemia.
Plain-language title generated from the registry record
Registry title: Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06982274, who can take part
Where in Brazil
- Instituto do Câncer do Estado de São PauloSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto do Cancer do Estado de São Paulo
- Trial code
- NCT06982274
- Record updated
- 30 May 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician; Use of other investigational drugs at the time of enrollment or within 30 days before study entry; Other active malignancy at the time of study entry; Uncontrolled and potentially fatal infections; Severe uncontrolled pulmonary or cardiac disease; Known HIV and/or hepatitis C infection; 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; 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%); Age <18 or >75 years; Lack of diagnostic confirmation at the genetic level; Severe hepatic or renal dysfunction; Pregnant or breastfeeding women.