OncoMatch/Clinical Trials/NCT06985485
Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy
Is NCT06985485 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Cancer type
Acute Lymphoblastic Leukemia
Disease stage
Required: Stage NEWLY DIAGNOSED, RELAPSED, REFRACTORY, MRD POSITIVE
Demographics
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.
Frequently asked questions
Is NCT06985485 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD19-targeted therapy, CD22-targeted therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage NEWLY DIAGNOSED or RELAPSED or REFRACTORY or MRD POSITIVE is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages