RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study
Chen Suning
124 participants
Feb 5, 2024
INTERVENTIONAL
Conditions
Summary
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.
Eligibility
Inclusion Criteria7
- 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 and glucocorticoids ≦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 must sign the informed consent form.
Exclusion Criteria10
- 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 inappropriate for inclusion by the investigator
- Pregnant or breastfeeding patients
- The study patient was refused enrollment
Interventions
Reduced-intensity chemotherapy followed by Blinatumomab
HyperCVAD regimen
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06250959