Adult patients with acute promyelocytic leukemia
Conditions
Interventions
A:Induction therapy with combination of all-trans retinoic acid and homoharringtonine. Consolidation therapy after complete response with combination of cytarabine and homoharringtonine. All patients
B:Induction therapy with combination of all-trans retinoic acid and daunorubicin/idarubicin. Consolidation therapy with combination of cytarabine and daunorubicin/idarubicin or mitoxantrone. All patie
C:Induction therapy with combination of all-trans retinoic acid and daunorubicin homoharringtonine. Consolidation therapy with combination of cytarabine and daunorubicin and/or homoharringtonine. All
D:Induction therapy with combination of all-trans retinoic acid,arsenic trioxide and daunorubicin/idarubicin. Consolidation therapy with combination of cytarabine and daunorubicin/idarubicin or mitoxa
Sponsors
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Male and female, ages 16-59 years; 2. Subjects must be diagnosed with acute promyelocytic leukemia, based on bone marrow morphology and cytogenetic results, demonstrating the presence of the t (15;17) and/or PML-RARa; 3. ECOG performance status (PS) score 0-2; 4. Adequate renal, hepatic and cardiac function defined as: serum CR < 2.0 times the institutional upper limit of normal (ULN), TB <=1.5 times the ULN, AST and ALT <=2.5 times the ULN, myocardial enzymes < 2.0 times the ULN, cardiac ejection fraction determined by echocardiography within normal range; 5. To be able to swallow or per os; 6. Patients must complete the all listed screening assessments; 7. The informed consent must be signed prior to any study related screening procedures being performed. Signed informed consent if the patient older than 18 years. Signed informed consent by the patient's guardian if the patient younger than 18 years. Signed informed consent by the patient's guardian or linear relative if there are disadvantages about patient therapy signed by the patient.
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy for leukemia; 2. Secondary leukemia; 3. Concurrent other blood diseases; 4. Prior or concurrent malignancy (requiring active intervention); 5. Women who are pregnant or breastfeeding, women with a positive pregnancy test at enrollment; 6. Hepatic, renal function was abnormal, beyond the inclusion criteria; 7. Uncontrolled or significant cardiovascular disease, including any of the following: 1) Uncontrolled or symptomatic angina; 2) Myocardial infarction within 6 months; 3) Any history of clinically significant arrhythmias; 4) Uncontrolled or symptomatic congestive heart failure (> NYHA grade 2); 5) Ejection fraction lower than the lower limit of normal range; 8. Uncontrolled infections (including active tuberculosis, pulmonary aspergillosis); 9. AIDS or chronic hepatitis C; 10. Epilepsy, dementia and other mental disorders requiring drug treatment, history of non-compliance to regimens or inability to grant consent; 11. Drug abuse, medical, psychological or social conditions which may interfere with the subjects involved in research or evaluation of research results; 12. The investigator believed that the patient is not suitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival;Rate of complete remission;overall survival;Rate of molecular remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| tolerability; | — |
Countries
China
Contacts
Public ContactJianxiang Wang
Outcome results
None listed