Last updated: April 3, 2024
Sponsor: Chen Suning
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
Blinatumomab Injection [Blincyto]
Doxorubicin
Clinical Study ID
NCT06250959
BEAT-ALL-2024
Ages 15-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 15-65
- Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
- Newly diagnosed patients without prior induction therapy (except hydroxyurea andglucocorticoids ≦5 days
- ECOG score 0-3
- Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
- Renal function: endogenous creatinine clearance ≧30ml/min
- Patients must be able to understand and willing to participate in the study and mustsign the informed consent form.
Exclusion
Exclusion Criteria:
- Ph+ (BCR-ABL1 positive) ALL
- T cells ALL
- Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
- Acute mixed-cell leukemia
- Central nervous system leukemia
- HIV infection
- HBV-DNA or HCV-RNA positive
- Patients with grade 2 or higher heart failure and other patients deemed inappropriatefor inclusion by the investigator
- Pregnant or breastfeeding patients
- The study patient was refused enrollment
Study Design
Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Blinatumomab Injection [Blincyto]
Phase: 2
Study Start date:
February 05, 2024
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215000
ChinaActive - Recruiting
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