Randomized,International Multi-center Clinical Trial of RIF Plus RA for Non-high-risk APL (RIF)
Acute Promyelocytic Leukaemia
About this trial
This is an interventional treatment trial for Acute Promyelocytic Leukaemia focused on measuring Realgar-Indigo Naturalis Formula, Retinoic Acid
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed APL patient (with WHO performance status)
- Age 18-70
- ALT and AST of maximum 2·5 times the ULN, and bilirubin concentration of maximum two times the ULN
- Creatinine concentration of maximum three times the ULN
- Performance status of 0-2 grade (ECOG)
- WBC ≤ 10 x 109/L before the treatment
- Informed Consent Paper signed
Exclusion Criteria:
- Cerebral hemorrhage
- Pregnancy
- Concomitant severe psychiatric condition or anything else against the fulfillment of the plan
- Clinically significant arrhythmias or electrocardiogram abnormalities (QT>500ms)
- Refusal to sign off the Informed Consent Paper
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Compound Realgar-Indigo Naturalis Formula Plus Retinoic Acid
Arsenic trioxide Plus Retinoic Acid
Induction: a) RIF: 60 mg/kg daily until CR, b) ATRA: 25 mg/m² daily until CR; Consolidation: a) RIF: 60 mg/kg daily, in a 4-week on 4-week off regimen for four cycles in a 4-week on 4-week off regimen for four cycles b) ATRA: 25 mg/m² daily, in a 2-week on 2-week off regimen for seven cycles
Induction: a) Arsenic trioxide: 0·15 mg/kg daily until CR, b) ATRA: 25 mg/m² daily until CR Consolidation: a) Arsenic trioxide: 0.15mg/kg daily, in a 4-week on 4-week off regimen for four cycles b) ATRA: 25 mg/m² daily, in a 2-week on 2-week off regimen for seven cycles Expected Efficacy: Oral RIF plus ATRA is not inferior to intravenous arsenic trioxide plus ATRA for achieving 2-year EFS.