eligibility_summary
Eligible: adults 55-69 with acute leukemia or MDS (any HCT-CI), transplant-eligible, no HLA-matched donor but a haploidentical donor available, and able to consent. Exclude: severe infection, pregnant/lactating, unable/unwilling to use effective contraception during dosing and 90 days after, not HSCT-eligible, in another trial within 1 month, unlikely to complete or unsuitable, cannot understand/accept consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05902416 tests a reduced-intensity conditioning (RIC) haploidentical HSCT strategy for elderly AML/MDS. Interventions and mechanisms: • Cytarabine (antimetabolite) inhibits DNA synthesis, cytotoxic to leukemic blasts. • Busulfan (alkylating agent) DNA crosslinking, myeloablation. • Fludarabine (purine analog antimetabolite) inhibits DNA polymerase/ribonucleotide reductase, lympho/myelosuppression. • Cyclophosphamide (alkylating prodrug) DNA crosslinking, cytotoxic/immunosuppressive. • Semustine/lomustine (nitrosourea alkylator) DNA alkylation/carbamoylation, cytotoxic. • Anti-thymocyte globulin (polyclonal antibody) depletes T cells to reduce rejection/GVHD. GVHD prophylaxis: cyclosporine A (calcineurin-NFAT inhibitor), mycophenolate mofetil (IMPDH inhibitor, blocks de novo guanine), methotrexate (antifolate/DHFR inhibitor). Infection prophylaxis: ganciclovir (viral DNA polymerase inhibitor) for CMV. Targets/pathways: leukemic/MDS blasts and recipient marrow, T cells (host/donor) for GVHD/rejection control, DNA synthesis/crosslinking, calcineurin signaling, and purine/folate metabolism, CMV replication (EBV/CMV monitored).