Acute Promyelocytic Leukemia
Conditions
Interventions
Trial Group:Retinoid acid capsules 25mg/m^2/d, oral twice daily
Arsenic trioxide 0.16mg/m^2/d, intravenous infusion (or Compound Huangdai tablets 60mg/kg/d, oral)
Control Group:Retinoid acid tablets 25mg/m^2/d, oral twice daily
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years. 2. Newly diagnosed acute promyelocytic leukemia confirmed by both cytomorphology and molecular analysis. For patient eligibility, the diagnosis must be genetically confirmed (detection of PML::RARa fusion gene positivity in bone marrow aspirate or confirmation of t(15;17) by cytogenetics/FISH). However, to avoid delaying treatment, patients may be randomized based on morphological diagnosis alone before genetic test results are available. 3. Leukocyte count <= 10 × 10^9/L at diagnosis. 4. ECOG performance status: 0-2. 5. Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum bilirubin <= 2.5 × ULN (upper limit of normal). 6. Serum creatinine <= 3.0 mg/dL (<= 260 µmol/L). 7. Able and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with known allergy to the investigational drug(s). 2. Lack of genetically confirmed diagnosis. 3. Presence of uncontrolled, life-threatening infection. 4. Severe uncontrolled pulmonary or cardiac disease. 5. Subjects with severe arrhythmias, ECG abnormalities (QTc > 450 ms), or neuropathy. 6. Pregnant or lactating women, patients planning pregnancy, or patients whose partners plan pregnancy. 7. Subjects with active malignancy. 8. HIV-positive subjects. 9. Subjects who have used other investigational drugs at enrollment or within 30 days prior to study initiation. 10. Any other condition that, in the opinion of the investigator, may preclude the subject from completing the study or pose a significant risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-Free Survival Rate at 2 Years;Incidence of Headache Adverse Events (Headache Lasting >=30 Minutes Without Analgesics [Referencing Migraine]) During Suspected APL Phase or Induction Period;Early Mortality Rate During Induction Period;Molecular Response Rate (Fusion Gene Negativity) After Induction Period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade and Duration of Headache Adverse Events During Suspected APL Phase or Induction Period;Incidence of Hematologic and Non-Hematologic Toxicity Events During Treatment;Overall Survival Rate at 2 Years;Cumulative Incidence of Relapse Rate at 2 Years; | — |
Countries
China
Contacts
Public ContactZhu honghu
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed