Last updated 16 days ago
Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
115 patients around the world
Available in Brazil
This is a non-randomized, multicenter, prospective study aimed at treating patients with
newly diagnosed acute promyelocytic leukemia (APL) using a combination of oral arsenic
and ATRA. For patients classified as high-risk (white blood cell count >10×10⁹/L),
low-dose chemotherapy will be added. The primary objective is to evaluate the 2-year
overall survival (OS) in these patients, comparing it to a historical control group
treated with ATRA and chemotherapy according to the IC-APL 2006 protocol. Secondary
objectives include: Comparing complete response rates, disease-free survival, cumulative
incidence of relapse, and early mortality with those reported in the IC-APL 2006 study
(historical controls), as well as with outcomes reported in developed countries;
Comparing the cumulative incidence of myelodysplasia or secondary leukemia; Comparing the
toxicity profile with historical data; Assessing the molecular remission rate after
consolidation; Evaluating the reduction in PML/RARA transcript levels during treatment;
Comparing the duration of patient hospitalization with historical results.
Instituto do Cancer do Estado de São Paulo
1Research sites
115Patients around the world
This study is for people with
Leukemia
Promyelocytic leukemia
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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).Women must meet at least one of the following criteria to be eligible for inclusion in the study: After undergoing hysterectomy or bilateral oophorectomy.Women must meet at least one of the following criteria to be eligible for inclusion in the study: Continuous and correct use of a contraceptive method with a Pearl Index <1% (e.g., implants, oral contraceptives, intrauterine devices).Women must meet at least one of the following criteria to be eligible for inclusion in the study: Sexual abstinence.Women must meet at least one of the following criteria to be eligible for inclusion in the study: Vasectomy of sexual partner.
- 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.Significant arrhythmias, ECG abnormalities, or neuropathy: History or presence of significant ventricular or atrial tachyarrhythmia.Significant arrhythmias, ECG abnormalities, or neuropathy: Clinically significant resting bradycardia (<50 beats per minute).Significant arrhythmias, ECG abnormalities, or neuropathy: QTc > 500 ms on ECG screening for both sexes.Significant arrhythmias, ECG abnormalities, or neuropathy: 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.
Sites
Instituto do Cancer do Estado de Sao Paulo
Recruiting
StudyIC-APL2020
SponsorInstituto do Cancer do Estado de São Paulo
Study typeInterventional
Conditions
Promyelocytic leukemia
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06982274
