acute leukemia
Conditions
Interventions
Low Dose Group:Cladribine + cytarabine + granulocyte colony stimulating factor, 3 days of treatment
High Dose Group:Cladribine + cytarabine + granulocyte colony stimulating factor, 5 days of treatment
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
No minimum to 16 Years
Inclusion criteria
Inclusion criteria: 1. Aged = 6 months; 5. No serious heart, lung, liver and kidney diseases; 6. The patients or their parents understand and are willing to sign the informed consent form; 7. Children with relapsed or high-risk acute leukemia: (1) Refractory acute leukemia definition: Primary patients who had received two courses of standard treatment with incomplete remission (CR), and after CR, who had received consolidation and intensive therapy, relapsed within 12 months, relapsed after 12 months without response to conventional chemotherapy, relapsed after 2 or more relapses extramedullary, persistent leukemia; (2) Relapse acute leukemia definition: 1) Morphological relapse: leukemic cells > 20% , if the leukemic cells reappeared in the peripheral blood, or the extramedullary infiltration of leukemic cells; 2) Molecular relapse: MRD was positive in the bone marrow and/or peripheral blood twice in succession, and the level of MRD was more than 10 times of that before 4 weeks. Diagnosis of molecular recurrence requires at least two tests, with a 4-week interval between the tests; (3) High-risk acute myeloid leukemia: According to the 2022 edition of the CSCO guidelines for the diagnosis and treatment of childhood and adolescent leukemia definition; (4) High-risk acute lymphocyte leukemia: According to the 2022 edition of the CSCO guidelines for the diagnosis and treatment of childhood and adolescent leukemia definition.
Exclusion criteria
Exclusion criteria: 1. High risk and recurrent acute promyelocytic leukemia (M3); 2. Patients with cardiac insufficiency: Ejection Fraction (EF) = 2mg/dL (34.2µmol/L); SCr > 2.5mg/dL (221µmol/L); 4. Because of the severe mobility infection before transplantation, children who could not tolerate pretreatment by assessment of reseacher; 5. Those who had other malignant tumors and needed to be treated; 6. The patients who was deemed unfit for joining in this trial by reseachers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease free survival;relapse rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival;2-year progress free survival;Adverse event related to transplantation;Transplant-related mortality; | — |
Countries
China
Contacts
Public ContactHu Shaoyan
Children's Hospital of Soochow University
Outcome results
None listed