An open-label randomized comparative trial of blinatumomab for B-cell acute lymphoblastic leukemia
- Conditions
- B-precursor A
- Registration Number
- JPRN-jRCT2031230581
- Lead Sponsor
- Kato Motohiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 180
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method