eligibility_summary
Include: Age 1–<25, relapsed/refractory B‑ALL, CD19/22+ blasts ≥5% (marrow/blood), anthracycline‑ineligible/PEG‑ASP intolerant, PS ≥50, asymptomatic CNS ok, labs: bili ≤1.5×ULN (≤3× Gilbert), eGFR ≥60, AST/ALT ≤3×ULN (≤5× hepatic). pregnancy test neg, contraception. Exclude: significant CNS/cardiac disease, uncontrolled infection or HBV/HCV/HIV, active GVHD, not recovered from prior therapy (limited cytoreduction ok), pregnancy/lactation, trisomy 21 or marrow failure, noncompliance/other trials
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05645718 (Phase II, recruiting): pedi-cRIB for relapsed pediatric/AYA B-ALL. Interventions and mechanisms: mini-hyper-CVD—cyclophosphamide (alkylating prodrug, DNA crosslinks), vincristine (vinca alkaloid, microtubule inhibitor), dexamethasone (glucocorticoid), intrathecal methotrexate (antimetabolite, DHFR inhibitor) and cytarabine (antimetabolite, Ara-CTP inhibits DNA polymerase), rituximab (anti-CD20 monoclonal antibody), inotuzumab ozogamicin (anti-CD22 antibody–drug conjugate delivering calicheamicin), blinatumomab (CD19xCD3 BiTE engaging T cells to kill CD19+ blasts). Additional agents: mercaptopurine (purine analog), prednisone (glucocorticoid), pegfilgrastim (G-CSF analog, supportive). Targets/pathways: B-cell antigens CD19, CD22, CD20, T-cell CD3 activation, DNA synthesis/repair, microtubules, glucocorticoid receptor, G-CSF receptor. Aim: deepen remission (CR/MRD−) and control CNS disease, enabling HSCT.