Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
washington; seattle; swedish cancer
PURPOSE: Standard cytotoxic induction chemotherapy for acute myeloid leukemia (AML) results in prolonged neutropenia and risk of infection. Romyelocel-L is a universal, allogeneic myeloid progenitor cell product being studied to reduce infection during induction chemotherapy.
PATIENTS AND METHODS: One hundred sixty-three patients with de novo AML (age ≥ 55 years) receiving induction chemotherapy were randomly assigned on day 0 (d0), of whom 120 were evaluable. Subjects received either romyelocel-L infusion on d9 with granulocyte colony-stimulating factor (G-CSF) starting daily d14 (treatment group) or G-CSF daily alone on d14 (control) until absolute neutrophil count recovery to 500/µL. End points included days in febrile episode, microbiologically defined infections, clinically diagnosed infection, and days in hospital.
RESULTS: Mean days in febrile episode was shorter in the treatment arm from d15 through d28 (2.36
CONCLUSION: Subjects receiving romyelocel-L showed a decreased incidence of infections, antimicrobial use, and hospitalization, suggesting that romyelocel-L may provide a new option to reduce infections in patients with AML undergoing induction therapy.
Desai, Pinkal M; Brown, Janice; Gill, Saar; Solh, Melham M; Akard, Luke P; Hsu, Jack W; Ustun, Celalettin; Andreadis, Charalambos; Frankfurt, Olga; Foran, James M; Lister, John; Schiller, Gary J; Wieduwilt, Matthew J; Pagel, John M; Stiff, Patrick J; Liu, Delong; Khan, Irum; Stock, Wendy; Kambhampati, Suman; Tallman, Martin S; Morris, Lawrence; Edwards, John; Pusic, Iskra; Kantarjian, Hagop M; Mamelok, Richard; Wong, Alicia; Van Syoc, Rodney; Kellerman, Lois; Panuganti, Swapna; Mandalam, Ramkumar; Abboud, Camille N; and Ravandi, Farhad, "Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia." (2021). Articles, Abstracts, and Reports. 5006.