eligibility_summary
Eligible: Newly diagnosed Ph− B‑ALL (WHO 2016), CD22+, age ≥60 or 18–59 with ECOG 2–3 or serious comorbidities not fit for intensive chemo, estimated survival ≥3 months, consent and contraception, agree to study procedures. Exclude: Burkitt or ambiguous lineage leukemia, pregnancy, uncontrolled infection, chronic liver disease/VOD/SOS, significant arrhythmias/heart block (unless pacemaker), HBV/HCV/HIV+, psychiatric illness, any condition deemed unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial in newly diagnosed elderly/unfit Ph-negative B-ALL testing low-dose chemotherapy plus immuno-targeted agents. Key drugs and types/mechanisms: Inotuzumab ozogamicin (anti-CD22 antibody-drug conjugate delivering calicheamicin), Blinatumomab (CD19xCD3 bispecific T-cell engager), Venetoclax (oral BCL-2 inhibitor), with vincristine (vinca alkaloid microtubule inhibitor), cyclophosphamide (alkylator), methotrexate (antifolate/DHFR inhibitor), cytarabine (pyrimidine antimetabolite/DNA polymerase inhibitor), 6-mercaptopurine (purine antimetabolite), and dexamethasone/prednisone (glucocorticoids). Targets/pathways: CD22+ and CD19+ B-ALL blasts, T-cell activation via CD3 to kill B cells, mitochondrial apoptosis via BCL-2 inhibition, microtubules, DNA crosslinking, folate, purine, and pyrimidine synthesis pathways. CAR-T or HSCT allowed in first CR.