Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia (IC-APL2020)

Instituto do Cancer do Estado de São Paulo

Status and phase

Enrolling

Phase 2

Conditions

Acute Promyelocytic Leukemia (APL)

Treatments

Drug: Realgar-Indigo Naturalis Formulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06982274

1483/2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment

115 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.