Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15+
SponsorThe First Affiliated Hospital of Soochow University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) patients aged ≥60 years, as per NCCN guidelines.
Left ventricular ejection fraction (LVEF) ≥40% by echocardiogram
Creatinine clearance ≥30 mL/min (by any formula)
ALT and AST ≤3×ULN, total bilirubin ≤2×ULN (unless attributed to leukemia)
Disqualifiers
Presence of central nervous system (CNS) or other extramedullary disease.
Concurrent other active malignancies or malignancies requiring treatment.
Prior exposure to CD19- or CD22-targeted therapies (including but not limited to CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T).
Use of immunosuppressive agents within 2 weeks prior to signing informed consent, or planned long-term immunosuppressive therapy after enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
Blinatumomab and Inotuzumab Ozogamicin
DrugSubjects 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.
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: Unfit and Fit-Decline B-ALLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Survival(OS)
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Time frame
2 yearsSecondary outcomes
1
CR rate(CRR)
CR rate (CR defined as bone marrow blasts \< 5% and no Auer rods, absence of extramedullary disease, ANC ≥ 1.0 × 109/L \[1000/µL\], platelet count ≥ 100 × 109/L \[100,000/µL\], and independence of RBC transfusions).
Time frame
2 years2
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the rate of CR, CRi (including complete remission with incomplete platelet recovery \[CRp\], PR, and MLFS.
Time frame
2 years3
Event-free survival(EFS)
Event-free survival (EFS) is defined as the time from the start of treatment until treatment failure, relapse from remission, or death from any cause, whichever occurs first.
Time frame
2 years4
Relapse-free survival(RFS)
Relapse-free survival(RFS) is the time from achievement of complete remission (CR) to the first documented relapse or death from any cause. Patients who die without evidence of relapse are typically censored at the last disease-free assessment.
Time frame
2 yearsOther outcomes
1
immune function
To investigate the impact of the full-course sequential immunotherapy regimen on patients' immune function.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov