eligibility_summary
Eligible: T‑ALL in hematologic CR/CRi after ≥2 intensive chemo blocks with persistent/recurrent MRD ≥10^-4 confirmed centrally, prior allo‑SCT allowed if no GVHD needing immunosuppression, ECOG 0–2, adequate labs (ANC≥750/µL, Plt≥75k, bili≤2, AST/ALT≤3×ULN, Cr≤1.5×ULN or CrCl>30), controlled HIV/HBV/HCV, inactive CNS disease, NYHA ≤2B, contraception/negative pregnancy test, consent, other malignancy allowed if non‑interfering. Exclude: pregnant or breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05289687: Single-arm Phase II in adults with T-ALL in morphologic CR but MRD-positive. Intervention: subcutaneous daratumumab-hyaluronidase (anti-CD38 IgG1 monoclonal antibody + recombinant hyaluronidase PH20) weekly x4, with additional courses guided by MRD. If MRD persists, daratumumab is combined with chemotherapy (either high-dose cytarabine + methotrexate, or methotrexate/vincristine/pegaspargase ± intrathecal methotrexate). Mechanisms: Daratumumab binds CD38 on T-ALL blasts, inducing complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity/phagocytosis, apoptosis, and immunomodulation, hyaluronidase enhances SC delivery. Chemo mechanisms: cytarabine (antimetabolite DNA chain termination), methotrexate (DHFR/folate pathway inhibition), vincristine (microtubule inhibitor), pegaspargase (asparagine depletion). Targets: CD38+ T-lymphoblasts, CD38 signaling, immune effector pathways, DNA synthesis/folate metabolism, microtubules, asparagine dependence.