Acute promyelocytic leukemia
Conditions
Interventions
1:Intravenous arsenic trioxide plus ATRA
2:Intravenous arsenic trioxide plus ATRA plus conventional chemotherapy
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
15 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed APL by cytomorphology, confirmed also by molecular analysis; 2. aged 15 to 80 years; 3. WHO performance status 0-2; 4. WBC in peripheral blood <40*10^9; 5. Serum total bilirubin <=3.0 mg/dL (<=51umol/L); 6. Serum creatinine <=3.0 mg/dL (<=260umol/L); 7. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. cerebral ischemic; 2. pregnancy; 3. Subjects who cannot sign written informed consent; 4. Significant arrhythmias, EKG abnormalities or neuropathy; 5. During induction the WBC in peripheral blood >=50*10^9; 6. Subjects who cannot comply with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Event-free survival (EFS);Rate of hematological complete remission;Overall survival rate;Rate of incidence of relapse;Incidence of hematological and non-hematological toxicity episodes during treatment;Quality of life at the end of induction therapy and at the end of the consolidation course;PML/RARa fusion transcripts; | — |
Countries
China
Contacts
Public ContactHuaiyu Wang
Outcome results
None listed