eligibility_summary
Eligibility: age 0–39 with T‑cell ALL in ≥2nd remission (≤5% blasts) or relapsed T‑cell lymphoblastic lymphoma now in CR (incl. secondary malignancy), planned allogeneic SCT with donor, PS ≥60%, recovered from prior therapy, adequate organ function, consented. Exclude: prior auto/allo SCT, uncontrolled infection, allergy to mannitol/sorbitol/corticosteroids/mAbs/human proteins, pregnant/breastfeeding, HIV/HBV/HCV, COPD, asthma, or significant cardiac disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT04972942 (Phase I). Intervention: Daratumumab (Darzalex), a human IgG1κ anti-CD38 monoclonal antibody, given IV after myeloablative total-body-irradiation conditioning and allogeneic HCT in children, adolescents, and young adults with high‑risk T‑ALL/T‑lymphoblastic lymphoma. Dosing: weekly ×8 (induction), then every 2 weeks ×8 (consolidation), then every 4 weeks to day +270 (maintenance). Mechanism: binds CD38 on malignant lymphoblasts and other CD38+ cells, inducing complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity/phagocytosis, and apoptosis, also immunomodulates by depleting CD38+ immune subsets. Targets/pathways: CD38 antigen on T-ALL/T-LLy cells, effector NK/complement pathways. Correlatives: NGS-MRD, pharmacokinetics/pharmacodynamics, T-cell repertoire/immune reconstitution.