NCT06985485

Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy

A Phase II Trial of Sequential Blinatumomab and Inotuzumab Ozogamicin in Newly Diagnosed (Unfit/Fit-Declined), Relapsed/Refractory, and MRD-Positive B-ALL

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

This trial is a non-blinded, single-center, open-label, single-arm clinical study to evaluate a full-course immunotherapy regimen in patients with B-cell acute lymphoblastic leukemia (B-ALL). The study population includes newly diagnosed patients who are unfit for or decline intensive chemotherapy, as well as patients with relapsed/refractory disease or with measurable residual disease (MRD) positivity following prior chemotherapy. The trial aims to explore the efficacy and safety of sequential therapy with a CD19-directed CD3 T-cell engager and inotuzumab ozogamicin. 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.

Conditions

• Acute Lymphoblastic Leukemia
• Immunotherapy
• Blinatumomab
• Inotuzumab Ozogamicin

Interventions

Type	Name	Description
DRUG	Blinatumomab and Inotuzumab Ozogamicin	Subjects who meet the study criteria during screening will receive induction therapy consisting of low-intensity chemotherapy combined with a CD19-directed CD3 T-cell engager with or without TKIs. Regimen includes dexamethasone, vindesine, followed by blinatumomab dosed by body weight: pts ≥45 kg receive fixed dosing (9 µg/day days 1-7, 28 µg/day days 8-28), pts \<45 kg receive BSA-adjusted dosing (5 µg/m²/day days 1-7, 15 µg/m²/day days 8-28). Philadelphia chromosome-positive ALL pts receive second-generation TKIs, with subsequent switch to third-generation TKIs or asciminib upon resistance. If morphologic remission is not achieved after initial therapy, a salvage cycle with InO will be administered. Post-remission consolidation chemotherapy includes high-dose methotrexate followed by sequential immunotherapy: BiTE (per weight-stratified dosing), then after a 2-week break, InO (0.8 mg/m² on day 1), followed by another 2-week break.This sequence is repeated for 4 cycles.

Timeline

• Start date: 2025-05-17
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-05-22
• Last updated: 2026-03-24

Locations

1 site across 1 country: China