B-precursor ALL
Conditions
Interventions
- Control Arm: active comparator, other
Participants will receive MTX 20 mg/m^2 orally once weekly from weeks 1 through 74.
6-MP 50 mg/m^2 will be administered orally daily from weeks 1 through 74.
12mg
- BLIN Arm: experimental, active comparator, other
Participants will receive intravenous blinatumomab continuously from week 1 to week 4 (28 days). Injections are followed by a 35-day treatment-
12mg
Sponsors
Kato Motohiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 28 days to 24 years of age inclusive, at the time of signing the informed consent. 2. Participants who are diagnosed B-precursor ALL. 3. The risk stratification is IR. 4. Patients in complete remission after consolidation therapy. 5. The intention to use contraception during the 28-day period after the end of the administration of the investigational drug. 6. Provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, or suspected of being pregnant 2. A prior history of CD19-targeted therapy 3. Concurrent participating in a clinical trial 4. BCR-ABL1 positive 5. Having any of the following poor prognostic factors: - MLL-AF4 positive or TCF3-HLF positive or hypodiploid (=10^-3 at the end of early intensive therapy - Central Nervous System (CNS) Infiltration at diagnosis (CNS3) 6. Mature B-cell lymphoblastic leukaemia 7. MYC gene translocation positive 8. Down Syndrome 9. Malignant hypertension 10. Pulmonary fibrosis 11. Interstitial pneumonia 12. Liver cirrhosis 13. Known infection with HIV or hepatitis B virus (HBsAg positive) 14. Poorly controlled diabetes mellitus 15. Uncontrolled infection 16. Deep thrombosis requiring treatment. 17. Psychiatric disorders that may prevent treatment according to the protocol 18. Active malignancy other than ALL 19. Past History of primary or acquired immunodeficiency 20. Any inappropriate status to participate in this clinical trial judged by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival (OS) - Time to relapse - Time to non-relapse mortality - Adverse event of CTCAE grade 4 or worse | — |
Contacts
Public ContactMotohiro Kato
The University of Tokyo Hospital
Outcome results
None listed