acute lymphoblastic leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects or their legal representatives should signed informed consent; 2. Male or non-pregnant female; 3. Subjects must younger than 60, and the expected survival is 3 months or more; 4.The score of ECOG physical status must be 0 to 2; 5.The laboratory values should be (unless caused by the leukemia): creatinine clearance >=50mL/min, or serum creatinine <= 1.5mg/dl, and bilirubin <=2 times the upper limit of normal; 6. Subjects must have been restored to <=1 degree of all non-hematologic toxicity (NCI CTC AE3.0 Edition) which have been from the previous treatment; 7. Subjects were diagnosed of relapsed / refractory acute lymphoblastic leukemia patients, according to FAB, or WHO diagnostic criteria.
Exclusion criteria
Exclusion criteria: 1. The patients were diagnosed of acute myeloid leukemia, or acute mixed cell leukemia; 2. The patients have been used high dose MTX and Ara-c, and clearly ineffective; 3. The patients with severe liver, kidney, or cardiopulmonary dysfunction; 4. The patients had uncontrolled or severe heart disease or infection, or mental illness; 5. The patients had received allogeneic hematopoietic stem cell transplantation; 6. The patients had other malignancies(unless the patients have completed treatment and doctors believe impossible relapse within 1 year).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate;Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safty;Progression-free survival;Overall survival; | — |
Countries
China