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Recruiting Phase 2

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

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About this study

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.

Condition
ALL, Adult, Philadelphia-Negative ALL
Tested
Blinatumomab Injection [Blincyto], Doxorubicin
Sponsor
Chen Suning

Who can join

Age
15 to 65 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 15 years
  • Maximum age: 65 years
  • Study condition: ALL, Adult, Philadelphia-Negative ALL
  • 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 10

  • 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

Where

1 site, 1 recruiting

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.