OncoMatch/Clinical Trials/NCT06985485
Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy
Is NCT06985485 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Blinatumomab and Inotuzumab Ozogamicin for acute lymphoblastic leukemia.
Treatment: Blinatumomab and Inotuzumab Ozogamicin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Disease stage
Required: Stage NEWLY DIAGNOSED, RELAPSED, REFRACTORY, MRD POSITIVE
Prior therapy
Must have received: chemotherapy — relapsed/refractory or MRD positivity after prior chemotherapy
Patients aged ≥15 years with relapsed/refractory B-ALL or MRD positivity after prior chemotherapy
Cannot have received: CD19-targeted therapy (CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 CAR-T)
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)
Cannot have received: CD22-targeted therapy (inotuzumab ozogamicin, CD22 CAR-T)
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)
Lab requirements
Kidney function
Creatinine clearance ≥30 mL/min (by any formula)
Liver function
ALT and AST ≤3×ULN, total bilirubin ≤2×ULN (unless attributed to leukemia)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥40% by echocardiogram
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); ≤Grade 1 dyspnea and oxygen saturation >91% without supplemental oxygen
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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