OncoMatch/Clinical Trials/NCT06982274
Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
Is NCT06982274 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Realgar-Indigo Naturalis Formulation for acute promyelocytic leukemia (apl).
Treatment: Realgar-Indigo Naturalis Formulation — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Prior therapy
Cannot have received: investigational drug
Use of other investigational drugs at the time of enrollment or within 30 days before study entry.
Lab requirements
Kidney function
Serum creatinine ≤ 3.0 mg/dl (≤ 260 μmol/l)
Liver function
Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l)
Cardiac function
No 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; LVEF < 50%
Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l); Serum creatinine ≤ 3.0 mg/dl (≤ 260 μmol/l); 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; LVEF < 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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