low and intermediary risk MDS
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: IPSS score 42%; CD8+/CD3+>30%; Th1/CD4+>18%; Tc1/CD8+>27%.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 child bearing potential must practice contraception. Men and women must continue birth control for the duration of the trial.
Exclusion criteria
Exclusion criteria: (1) >=5% marrow myeloblasts; (2) poor karyotype according to IPSS standards; (3) diagnosis of concurrent non–hematological malignanc; (4) Nursing and pregnant females are excluded; (5) Patients with active and uncontrolled infections are excluded; (6) Patients with history of hepatitis B, C, alcoholic liver disease or evidence of hepatopathy will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration of response;disease progress rate;total response rates;leukemic transformation;complete response rates;Median survival; | — |
Countries
China