eligibility_summary
Adults 18–65 with T‑ALL (ICC 2022, de novo or therapy‑related), BM blasts ≥20%, CD38+, ETP/near‑ETP or other very high‑risk T‑ALL, or T‑myeloid MPAL. Fresh BM/PB for full diagnostics. ECOG 0–2 (or reversible 3). Contraception and negative pregnancy test, consent. Excludes B‑ALL/Ph+, Down syndrome, prior systemic ALL chemo, uncontrolled cardiac/hepatic/renal/neuro disease, serious infection, active cancer (<2‑yr LE), or major surgery ≤2 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
DARATALL-VHR (NCT06253637) tests adding daratumumab to a pediatric-inspired chemotherapy backbone (GIMEMA LAL1913) in adults with very high‑risk T‑ALL (including ETP/near‑ETP and T‑myeloid MPAL) with CD38+ blasts. Intervention: subcutaneous daratumumab 1800 mg (weekly in cycles 1–2, then day 1 of cycles 3–8) plus multi‑agent chemo. Drug/type/mechanism: daratumumab is a human IgG1κ anti‑CD38 monoclonal antibody (immunotherapy) that eliminates CD38+ cells via ADCC, CDC, ADCP, and direct apoptosis/immune modulation. Targets: CD38 on T‑lymphoblasts (notably ETP) and CD38 signaling, aim is to raise post‑induction MRD‑negativity.