Actively Recruiting
RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
Led by Chen Suning · Updated on 2024-04-04
124
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 15 to 65 years
- Diagnosis of Philadelphia chromosome-negative (BCR-ABL1 negative) B-cell acute lymphoblastic leukemia according to WHO criteria
- Newly diagnosed without prior induction therapy except hydroxyurea or glucocorticoids for 5 or more days
- ECOG performance status score of 0 to 3
- Liver function: total bilirubin and aminotransferases (ALT, AST) less than or equal to 3 times upper limit of normal unless due to leukemia infiltration
- Kidney function: creatinine clearance of at least 30 ml/min
- Ability to understand and willingness to participate with signed informed consent
You will not qualify if you...
- Philadelphia chromosome-positive (BCR-ABL1 positive) ALL
- T-cell acute lymphoblastic leukemia
- Mature B-cell leukemia/lymphoma or B-cell lymphoma with extramedullary disease
- Acute mixed-cell leukemia
- Central nervous system leukemia
- HIV infection
- Positive for HBV-DNA or HCV-RNA
- Grade 2 or higher heart failure or other conditions deemed unsuitable by investigator
- Pregnant or breastfeeding
- Refusal to enroll in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
J
Jing Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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