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

Recruiting now · Phase 2

Conditions studied: Acute Promyelocytic Leukemia (APL)

In brief

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.

Key facts

Study ID: NCT06982274
Run by: Instituto do Cancer do Estado de São Paulo
People needed: 115
Starts: 2023-10-20
Expected to finish: 2029-11-01
Last updated by the study team: 2025-05-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Instituto do Cancer do Estado de Sao Paulo — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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