Oral etoposide combined with realgar natural indigo tablets and all-trans retinoic acid in the treatment of high-risk acute promyelocytic leukemia
Phase 1
- Conditions
- high-risk acute promyelocytic leukemia
- Registration Number
- ITMCTR2100005369
- Lead Sponsor
- People's Hospital, Institute of Hematology, Peking University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
1)Newly diagnosed high-risk APL(WHO classification 2016);2) Age from 18-70(18 and 70 are included);3) Without uncontrolled active infection;4) Without organ failure;5) Liver function:serum ALT and AST=2.5*ULN,serum bilirubin=2.0*ULN;6) Kidney function:serum Cr=3.0*
Exclusion Criteria
1) With cerebral hemorrhage; 2) Gestation;3) Suffering from mental illness or other conditions that cannot be carried out according to the scheme;4) Unable to take oral drugs;5) Uncontrolled active infection;6) Organ failure; 7) Allergic to etoposide.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method remission rate;death rate;
- Secondary Outcome Measures
Name Time Method Overall survival rate;safety;Event free survival rate;cumulative recurrence rate(1year \2year));