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eligibility_summary
Eligibility: Ages 16–65, candidates for haploidentical HSCT, AML or ALL in complete cytologic remission, or MDS requiring allogeneic transplant, ECOG ≤2. Exclusions: pregnant/lactating, prior allogeneic HSCT or organ transplant, uncontrolled major organ dysfunction (renal, liver, lung, heart, CNS), uncontrolled infection, HIV/HTLV‑1 positive, active hepatitis B/C, other serious conditions or history of other malignancies.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Anti‑T lymphocyte globulin (ATLG), a polyclonal IgG biologic immunosuppressant. Arms compare total doses 20 mg/kg (5 mg/kg/day ×4) vs 30 mg/kg (7.5 mg/kg/day ×4) given on days −5 to −2 before haploidentical HSCT with standard GVHD prophylaxis. Mechanism of action: Broad anti‑T‑cell antibodies that deplete and modulate T cells via complement-dependent cytotoxicity, ADCC, and apoptosis, they also inhibit T‑cell activation/proliferation and reduce trafficking, producing in vivo T‑cell depletion to prevent GVHD, may dampen antigen-presenting cell activity and inflammatory cytokine signaling. Targets: Alloreactive donor T lymphocytes driving GVHD, TCR‑driven alloimmunity and downstream GVHD inflammatory pathways. Goal: identify the ATLG dose that best prevents acute GVHD while limiting viral infections and other risks.