RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15-65
SponsorChen Suning
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Ph+ (BCR-ABL1 positive) ALL
T cells ALL
Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
Acute mixed-cell leukemia
Trial design
Treatments tested in this trial
- Blinatumomab Injection [Blincyto]
- Doxorubicin
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chen Suning
Lead sponsor
The First Affiliated Hospital of Soochow University
Sponsor institution
Source ClinicalTrials.gov