refractory/relapsed de nove or myelodysplastic syndrome (MDS) transformed acute myeloid leukemia (AML)
Conditions
Interventions
1:Aclacinomycin /Cytarabine (AA)
Sponsors
Shanghai Sixth People‘s Hospital
Eligibility
Sex/Gender
All
Age
23 Years to 77 Years
Inclusion criteria
Inclusion criteria: According to the criteria for the acute myeloid leukemia by classification of French-American-British Cooperative Group and at least one of the following conditions: Refractory AML was defined as CR could not be achieved after 2 courses of administration of standard combined chemotherapy regimen (anthracycline plus cytarabine; or homoharringtonine, HHT plus cytarabine in China). In this trial, refractory AML also included the patients whose BM blasts did not decline by over 50% after one course of standard chemotherapy.Relapsed AML was defined as reappearance of leukemic blasts in the peripheral blood or more than 5% blasts in the bone marrow after CR has been received ( cannot attribute to another causes ), or extramedullary relapse. And the patients must meet the following conditions at the same time; (1) adequate hepatic (serum bilirubin level <2*upper normal limit) and renal (serum creatinine <2*upper normal limit) function tests; (2) Performance status of =/< 2 by the ECOG scale; (3) Signed informed consent indicating that patients are aware of the clinical trail of this study; (4) Women of childbearing potential must practice contraception. Men and women must continue birth control for the duration of the trial.
Exclusion criteria
Exclusion criteria: (1) diagnosis of concurrent non–hematological malignanc; (2) Nursing and pregnant females are excluded; (3) Patients with active and uncontrolled infections are excluded; (4) Patients with history of hepatitis B, C, alcoholic liver disease or evidence of hepatopathy will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response;Overall survival; | — |
Countries
China
Contacts
Public ContactLi Xiao
Outcome results
None listed