Intermediate / High risk group B cell acute lymphoblastic leukemia
Conditions
Interventions
Group A:continuous 28 days’ blinatumomab followed by 3 cycles of high-dose methotrexate (HDMTX)
Group B:consolidation phase with two 14-day cycles of blinatumomab, alternating with 3 cycles of high-dose methotrexate (HDMTX).
NonRandonmized group:Venetoclax + mini-hyperCVD
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.All of the following conditions must be met: 1) Age >= 1 to<18 years old; 2) Bone marrow morphology diagnosis is acute lymphoblastic leukemia; 3) The immunological classification is B-cell acute lymphoblastic leukemia. 4) The danger level is classified as medium high risk group;
Exclusion criteria
Exclusion criteria: 1.As long as one of the following conditions is met, it should be excluded: 1)T-ALL, LR B-ALL patients with D19 MRD<1% and D46 MRD<0.01%; 2)sIgM+; 3) Diagnosis of acute fuzzy lineage leukemia based on WHO or EGIL criteria; 4) Chronic myeloid leukemia (CML) with acute lymphoblastic transformation; 5) Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) 6) trisomy 21 syndrome, or congenital or hereditary diseases with organ dysfunction; 7) Other secondary leukemia; 8) Congenital immunodeficiency or metabolic disorders; 9) Congenital heart disease with heart dysfunction; 10) Individuals who have used glucocorticoids for 14 days or more, ABL kinase inhibitors for more than 7 days, or have a history of chemotherapy or radiation therapy within the past 3 months prior to enrollment (excluding emergency radiation therapy taken to relieve airway compression symptoms);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall surviva;Cumulative recurrence rate; | — |
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