Children's Acute lymphoblastic leukemia with Ph chromosome
Conditions
Interventions
experimental group:realgar-Indigo naturalis formula
control group:placebo
Sponsors
Shanghai Chidren's Medical Center, Shanghai Jiaotong University school of Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: (all conditions must be met) 1. Aged 1-18 years (inclusive); 2. Diagnosis of acute lymphoblastic leukemia diagnosed by bone marrow morphology; 3. Diagnosis of B- or T-ALL by immunophenotyping: (could be accompanied by myeloid antigen expression other than MPO). 4. BCR-ABL1 fusion gene was found by molecular genetics (FISH/NGS/PCR) or ph+ chromosome / t (9,22) in cytogenetic.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: (should be excluded if had one of the following) 1. A definite history of (CML) chronic myeloid leukemia; 2. Morphology or immunophenotyping suggested that CML might change rapidly and BCR-ABL1 was P210. 3. Secondary leukemia; 4. Congenital immune deficiency disease; 5. Congenital heart disease with cardiac insufficiency; 6. Significantly prolonged QT interval (QTc >500 ms); 7. End-stage renal insufficiency; 8. Known allergic to realgar, salvia miltiorrhiza, Codonopsis, pilosula, Qingdai. 9. Patients with a history of glucocorticoids treatment >= 14 days, ABL kinase inhibitors treatment >= 7 days, any chemotherapy or radiotherapy within the first 3 months (except for emergency radiotherapy to relieve compression symptoms).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| D46 minimal residual diseas; | — |
Countries
China
Contacts
Public ContactShuhong Shen
Shanghai Chidren's Medical Center, Shanghai Jiaotong University School of Medicine
Outcome results
None listed