Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL
Status:
Recruiting
Trial end date:
2023-08-31
Target enrollment:
Participant gender:
Summary
Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in
phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in
the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid
and efficient clearance of MRD in patients. Therefore, its use in combination with less
intensive chemotherapy for initial induction therapy in newly diagnosed patients may result
in favorable response rates, greater depth of remission, and lower treatment-related toxic
effects.
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative
(PH-) B-ALL were enrolled and treated with reduced-intensity chemotherapy followed by
Blinatumomab as the basis of induction therapy. The clinical remission rate, MRD negative
rate and treaty-related adverse reactions were evaluated in newly diagnosed non-elderly
PH-B-ALL patients during induction therapy.
Phase:
Phase 2
Details
Lead Sponsor:
The First Affiliated Hospital of Soochow University