Key clinical point: Romyelocel-L plus granulocyte colony-stimulating factor (G-CSF) vs G-CSF monotherapy led to a significant reduction in the incidence of infections and length of hospitalization in patients with acute myeloid leukemia (AML) receiving induction chemotherapy.
Major finding: From days 15 to 28, romyelocel-L plus G-CSF vs G-CSF monotherapy significantly reduced the mean duration of febrile episodes (2.36 days vs 3.90 days; P = .02) and incidence of infections (6.8% vs 27.9%; P = .0013). Length of hospitalization was significantly shorter in the romyelocel-L plus G-CSF vs G-CSF monotherapy group (25.5 days vs 28.7 days; P = .002).
Study details: This phase 2 study included 163 patients with de novo AML receiving induction chemotherapy. Evaluable patients (n=120) were randomly assigned to receive either romyelocel-L plus G-CSF (n=59) or G-CSF monotherapy (n=61).
Disclosures: This study was supported by the Biomedical Advanced Research and Development Authority. Some investigators including the lead author reported ties with various pharmaceutical companies.
Source: Desai PM et al. J Clin Oncol. 2021 Jun 22. doi: 10.1200/JCO.20.01739 .