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

Recruiting Phase 2 Interventional Study
ALL, Adult Philadelphia-Negative ALL
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
15 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
124 (estimated)
Sponsor
Chen Suning · Other
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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.

Trial Locations
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Eligibility Criteria
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…
Contacts

Jing Lu

1377183627

lujing@suda.edu.cn

CONTACT