eligibility_summary
Eligibility: Adults 18–65 with Ph+ or BCR‑ABL1+ ALL, only limited prephase therapy allowed, ECOG ≤2, BCR‑ABL1 tested, normal/corrected K/Mg, lipase ≤1.5×ULN, QTcF ≤450 ms (men)/≤470 ms (women), contraception, consent, GMALL registry. Exclude: other recent cancer, prior TKI, drug contraindications, cardiac/PVD/stroke/TIA, CNS/autoimmune disease, HIV/HBV/HCV, pancreatitis, uncontrolled TG, liver dysfunction, severe infection, recent trial, hypersensitivity, nursing.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06061094 (GMALL-EVOLVE) tests targeted TKIs and immunotherapy in de novo Ph+ ALL. Interventions: 1) Imatinib (small-molecule, 1st‑gen tyrosine kinase inhibitor) + low‑intensity chemotherapy, 2) Ponatinib (small-molecule, 3rd‑gen pan–BCR‑ABL TKI active vs T315I) + low‑intensity chemotherapy, 3) Blinatumomab (bispecific T‑cell engager antibody, CD19xCD3), and 4) strategy-level “indication for allogeneic stem cell transplantation” (SCT, cellular therapy with graft‑versus‑leukemia effect). Mechanisms/targets: Imatinib inhibits BCR‑ABL1 (and KIT/PDGFR), blocking leukemic proliferation/survival, Ponatinib more potently inhibits BCR‑ABL1, including kinase‑domain mutants such as T315I, Blinatumomab redirects patient T cells (CD3) to kill CD19+ B‑ALL blasts. Pathways/cells targeted: BCR‑ABL1 signaling in Ph+ leukemic blasts, CD19 on B‑lineage cells, and T‑cell cytotoxic engagement, SCT targets residual leukemia via immune-mediated graft‑versus‑leukemia. MRD status guides blinatumomab use and SCT indication.