Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy
Status:
RECRUITING
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
This trial is a non-blinded, single-center, open-label, single-arm clinical study to investigate a full-course immunotherapy regimen in Unfit or Fit B-cell acute lymphoblastic leukemia (B-ALL) patients who decline chemotherapy (Fit-Decline). The trial aims to explore the efficacy and safety of sequential blinatumomab and inotuzumab ozogamicin therapy. The primary endpoint is overall survival (OS), while secondary endpoints include complete remission rate(CRR)Objective Response Rate(ORR)Event-free survival(EFS)Relapse-free survival(RFS)Cumulative incidence of relapse(CIR)Non-relapse mortality(NRM) and safety.
Phase:
PHASE2
Details
Lead Sponsor:
The First Affiliated Hospital of Soochow University