Low risk B-cell Acute Lymphoblastic Leukemia
Conditions
Interventions
MRD19>= 0.01% and NGS MRD46 = 10^-6:blinatumomab
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Must meet all items below: 1) Age older than 1 year and younger than 18 years. 2) Diagnosis of acute lymphoblastic leukemia by bone marrow morphology. 3) Diagnosis of B-ALL by immunophenotyping. 4) Low risk group;
Exclusion criteria
Exclusion criteria: 1.Should be excluded in the presence of any item below: 1) T-ALL 2) I/HR B-ALL group 3) sIgM+ 4) Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria. 5) Philadelphia chromosome positive ALL (Ph-ALL) 6) ALL evolved from chronic myeloid leukemia (CML). 7) Down's syndrome, or major congenital or hereditary disease with organ dysfunction 8) Secondary leukemia 9) Known underlying congenital immunodeficiency or metabolic disease 10) Congenital heart disease with cardiac insufficiency. 11) Glucocorticoid treatment for >=14 days, or ABL kinase inhibitors for > 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year event-free survival rate, EFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Cumulative incidence rate, CIR;The early deep remission rate;The rate of Grade 3 or above toxicities; | — |
Countries
China
Contacts
Public ContactXiaofan Zhu
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Outcome results
None listed