Acute myeloid leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. To be aged 18~ 75years and the elderly patient (60-75y)should be evaluated as fit; 2. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 3. Acute myeloid leukemia diagnosied by MICM criterion (rule out APL); 4. Expected survival longer than 3 months; 5. Meets the diagnosis criterion of refractory AML: Didn't reach CR after two cycles of standard induction; With blasts/leukemic cell clearance lower than 50% after one cycle of standard induction; Relapse within 6 months after first CR; Relapse later than 6 months after first CR and didn't respond to the former induction regimen; Relapse more than 2 times; 6. Meets the diagnosis criterion of relapse AML: more than 5% blasts found in bone marrow/peripheral blood after CR(rule out other cause, consolidation etc.); 7. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled infection or Other severe condition that patients can not tolerate chemotherapy; 2. relapsed more than 1 year after the last chemotherapy; 3. Heart failure NYHA III/IV, severe arrhythmia, ejection fraction less than 50% by echocardiography; 4. Severe neurological or psychiatric history; 5. Allergy to any drug in the CDE regimen; 6. Patients with a "currently active" second malignancy; 7. Patients underwent stem cell transplatation; 8. Patients with extra-medullary leukemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate;mortality related to study drug; | — |
Secondary
| Measure | Time frame |
|---|---|
| one year overall survival;remission duration;adverse event; | — |
Countries
China
Contacts
Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine