Acute Promyelocytic Leukemia
Conditions
Interventions
A:1. ATAR plus ATO: Oral administration of ATRA (45mg/d), plus intravenous injection of arsenic trioxide (0.16mg/kg/d), till achievement of morphological complete remission (not less than 28 days)
2. ATAR plus ATO: Oral administration of ATRA (45mg/d), plus intravenous injection of arsenic trioxide (0.16mg/kg/d), for 28 
A (to be continued):4. ATAR plus ATO: Oral administration of ATRA (45mg/d), plus intravenous injection of arsenic trioxide (0.16mg/kg/d), for 28 days
5. DA regimen: intravenous injection of Daunorubicin (45mg/m2/day) for 3 days plus cytarabine (200mg/day) for 7 days
6. ATAR plus ATO: Oral administration of ATRA (45mg/d), plus intrav
A (to be continued) :7. MA regimen: intravenous injection of Mitoxanetrone (10mg/day) for 3 days plus cytarabine (200mg/day) for 7 days
8. ATAR plus ATO: Oral administration of ATRA (45mg/d), plus intravenous injection of arsenic trioxide (0.16mg/kg/d), for 28 days
9. ATAR plus ATO: Oral administration of ATRA (45mg/d), plus intraven
A (to be continued) :10. ATAR plus ATO: Oral administration of ATRA (45mg/d), plus intravenous injection of arsenic trioxide (0.16mg/kg/d), for 28 days
11. Prophylaxis of central nervous system leukemia (CNS-L): intrathecal injection with 5mg dexamethasone plus 15mg MTX for 6 times totally after achievement of CR.
Sponsors
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Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: The enrolled acute promyelocytic leukemia (APL) patients should fulfill all the following requirements: 1) Newly diagnosed APL aged 15 to 75 years; 2) Morphological features of APL with bone marrow aspirate;3)t(15;17)(q22;q22) by karyotyping; 4) Positive PML/RARa fusion transcripts, and 5) A female patient should be not pregnant, and she should consent to use appropriate contraceptive methods during treatment and follow-up for the next 1 year.
Exclusion criteria
Exclusion criteria: The APL patients should be excluded with any of the following items: 1) relapsed APL; 2) APL without classical translocation of t(15:17); 3) Afflicted with other malignancies in the past 5 years; 4) Complicated with central nervous system leukemia (CNS-L); 5) Active hepatitis B infection, or positive antibody against hepatitis C virus; 6) Severe diseases which may constrain the enrollment, including a progressive infection, out-of-control diabetes, severe cardiac dysfunction or angina pectoris, hepatic or renal insufficiency, with 3- to 5- fold upper limit of normal range for GPT, GGT, or bilirubin, or creatinine clearance less than 50ml/min; 7) Administration of other therapeutic regimens 30 days before this enrollment; 8) Female APL patients during pregnant or lactation period, or without appropriate contraceptive methods, or 9) Disapproval of this clinical trial by researchers.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) (CR+PR);Adverse effects;Event-free survival (EFS) (3-year EFS);Time to progression (TTP); | — |
Primary
| Measure | Time frame |
|---|---|
| 3- year overall survival (OS);3- year disease free survival (DFS);PML/RARa fusion transcripts; | — |
Countries
China
Contacts
Public ContactJin-Song Yan
Outcome results
None listed