Relapse and refractory acute myeloid leukemia
Conditions
Interventions
single arm:combination of FLAG and Decitabine
Sponsors
Department of Hematology, Second Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 55 years old; 2) the diagnostic criteria of relapsed and refractory acute myeloid leukemia: the initial treatment of 2 courses that were invalid after the treatment of the standard scheme; after the consolidation and strengthening treatment after CR, the relapse within 12 months; the recurrence in 12 months after the conventional chemotherapy; 2 or multiple recurrence; the persistent presence of extramedullary leukemia; 3) ECOG physical condition score was 0, 1 or 2 when entering this study; 4) the expected life period is more than 3 months; 5) no severe complications, such as renal insufficiency and cardiac insufficiency; 6) GPT, GGT, bilirubin were less than 3-5 times that of the upper limit of the normal value in the first 2 weeks, and the serum creatinine was less than 2 times that of the upper limit of the normal value, and the myocardial enzyme was less than 2 times that of the upper limit of the normal value; 7) viral hepatitis virus copy number not exceeding 500 copy number; 8) the pregnancy test for women of childbearing age must be negative, and agreed to internal use of effective contraception measuresbe in the course of treatment and the following year; 9) must be able to understand the test plan, comply with the doctor's advice.
Exclusion criteria
Exclusion criteria: 1) those who are receiving any chemotherapy regimen; 2) in the past 4 weeks, there have been major surgical operations (excluding diagnostic surgical procedures); 3) evidence of the diseases of the central nervous system; 4) HBV active viral hepatitis, HCV antibody positive; 5) serious diseases that may limit patients' participation in the trial (for example, advanced infection, uncontrollable); Diabetes, severe heart failure, angina pectoris, liver and kidney insufficiency. 6) participating in other clinical trials or participating in other drug clinical trials within 3 months; 7) women who laced or did not take effective contraception or pregnancy; 8) the researchers believe that patients who are not suitable for this treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| partial remission rate;total survival rate;EFS;DFS;TRM; | — |
Countries
China
Contacts
Public ContactYan Jinsong
Second Affiliated Hospital of Dalian Medical University
Outcome results
None listed