Acute promyelocytic leukemia
Conditions
Interventions
Observation group:None
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed patients with classically high-risk APL confirmed at the molecular biological level (Sanz risk stratification); 2. Age 14~75 years old; 3. Liver and kidney function: blood bilirubin = 35 µmol/L, AST/ALT no more than 2 times the upper limit of normal, serum creatinine =50% on cardiac ultrasound, NYHA I/II for New York cardiac function class; 5. Physical condition score 0-4 (ECOG score); 6. Non-pregnant and lactating women; 7. For all women of childbearing age, a pregnancy test must be performed, hCG measurement to rule out pregnancy; If it is a female in the childbearing period, it should be contraceptive for at least one month before screening, and promise to use contraception for the entire study period and continue until the specified time after the end of the study; 8. Obtain informed consent signed by the patient or family member.
Exclusion criteria
Exclusion criteria: 1. Patients with low-to-intermediate-risk APL (Sanz risk stratification); 2. Patients with recurrent APL; 3. Patients with variant APL (molecular biology non-PML/RARa patients); 4. Patients with APL with identified central nervous system invasion; 5. Allergy to any of the study drugs involved in the protocol; 6. Liver and kidney function are obviously abnormal, exceeding the enrollment criteria; 7. Severe heart disease, including myocardial infarction and cardiac insufficiency; 8. Electrocardiogram (EKG) results: QTc interval greater than 450 msec; 9. Suffering from malignant tumors of other organs at the same time; 10. Active tuberculosis patients and human immunodeficiency virus (HIV) positive patients; 11. Inability to understand or follow the study protocol; 12. Patients under 14 years of age or over 75 years of age; 13. Pregnant or lactating women; 14. There are contraindications to anthracycline chemotherapy; 15. Drug addiction or mental illness; 16. Those who participate in other clinical research projects during the same period; 17. There are other circumstances that hinder the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early death rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival;Hematology remission rate;Hematologic adverse events and non-hematologic adverse events during treatment;Molecular remission rate;Overall survival; | — |
Countries
China
Contacts
Public ContactYang Shen
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed