An open-label, randomized, phase 2, two-arm study to investigate efficacy and safety of consolidation therapy augmented blinatumomab compared with standard consolidation in children and adolescents aged 0-24 years with front-line intermediate risk B-cell acute lymphoblastic leukemia - BLIN-B-A

Kato Motohiro0 sites180 target enrollmentStarted: January 22, 2024Last updated: April 23, 2024

Conditions

Trial Snapshot

No summary available.

•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.

•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 (<=44 or DNA index <0.85)
•- Non-CR on induction therapy
•- PCR-MRD >=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

Sponsor

Kato Motohiro