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RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.

RecruitingPhase 2Ages 15 Years - 65 YearsAllChen Suning
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 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 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 inappropriate for inclusion by the investigator * Pregnant or breastfeeding patients * The study patient was refused enrollment
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What it tests

  • Blinatumomab Injection [Blincyto]
  • Doxorubicin
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Where

1 site
The First Affiliated Hospital of Soochow University
Suzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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