Childhood leukemia
Conditions
Interventions
Treatment group:Bortezomib
control group:no
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Acute lymphoblastic leukemia patients aged from 1 month old ~18 years old. 2. And meet one of the following conditions: (1) Refractory ALLAt the end of the induction remission chemotherapy of CCCG-ALL-2020 regimen, bone marrow D19 MRD>=1%; (2) Relapsed ALLComplete remission (CR) was achieved after regular combination chemotherapy, followed by bone marrow and/or extramedullary relapse.
Exclusion criteria
Exclusion criteria: (1) Mature B-ALL, mixed phenotypic leukemia (excluding ALL associated with myeloid antigen expression) (2) The second tumor; (3) The expected survival time may be less than the treatment cycle; (4) Patients who have received bortezomib or other proteasome inhibitors before; (5) secondary to immunodeficiency disease; (6) The cumulative exposure to anthracycline should not exceed 400 mg /m2; (7) Receive other systemic drug treatment; (8) Patients considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal residual disease, MRD;Overall survival;Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood concentration of Bortezomib ;Population pharmacokinetic parameters of bortezomib; | — |
Countries
China
Contacts
Public ContactJu Xiuli
Qilu Hospital of Shandong University
Outcome results
None listed