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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06985485
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blinatumomab and Inotuzumab Ozogamicin — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 22, 2025
Start date
May 17, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Unfit and Fit-Decline B-ALL
    Newly diagnosed patients who are either: Unfit for intensive chemotherapy, defined as those whose physical conditions (e.g., age, comorbidities, organ dysfunction) preclude tolerance of standard intensive regimens as judged by investigators; or Fit-Declined, defined as patients with good performance status and adequate organ function who decline intensive chemotherapy for subjective reasons(e.g., fear of toxicity, personal preference). Patients with measurable residual disease (MRD) positivity and relapsed or refractory B-ALL following prior chemotherapy (without prior exposure to CD19/CD22-targeted therapies or CAR-T). A low-intensity chemotherapy regimen combined with a sequential treatment regimen of CD19-directed CD3 T-cell engager and inotuzumab ozogamicin is implemented.

Primary Outcome Measure

Overall Survival(OS) [ Time Frame: 2 years ]

Central Contacts

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