acute myeloid leukemia
Conditions
Interventions
treatment arm:cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Men and women; 2. Subjects have R/R-AML; 3. ECOG performance status (PS) score 0-3; 4. AST and ALT <=2.5 times the institutional ULN; Total bilirubin <=2.0 times the institutional ULN Serum creatinine<2.0 times the institutional ULN; 5. Women or men must take effective contraceptive measures, in women Serum or urine pregnancy tests must be negative in the screening and study periods; 6. Men must take effective contraceptive measures during or after treatment within 6 months; 7. Patients understand the disease and voluntarily received the study regimen and follow-up.
Exclusion criteria
Exclusion criteria: 1. History of tumors other than AML and received any treatment in 3 years, but exclusion superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN); 2. Activity viral or bacterial infection that would impair the ability of the subject to receive protocol therapy; 3. Concurrent autoimmune hemolytic anemia or immune thrombocytopenia; 4. Subjects suffered from the AIDSactivity hepatitis B or C virus; 5. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent; 6. Have known to any component of cladribine allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| one year LFS;one year OS; | — |
Countries
China
Contacts
Public ContactLu Yue
Sun Yat-sen University Cancer Center
Outcome results
None listed