OncoMatch/Clinical Trials/NCT06982274
Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
Is NCT06982274 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Demographics
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.
Frequently asked questions
Is NCT06982274 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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