Article ; Online: 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
2021 Volume 39, Issue 29, Page(s) 3261–3272
Abstract: ... in prolonged neutropenia and risk of infection. Romyelocel-L is a universal, allogeneic myeloid progenitor cell ... randomly assigned on day 0 (d0), of whom 120 were evaluable. Subjects received either romyelocel-L infusion ... 2.36 : Conclusion: Subjects receiving romyelocel-L showed a decreased incidence of infections ...
Abstract | 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. |
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MeSH term(s) | Adult ; Aged ; Antifungal Agents/therapeutic use ; Female ; Granulocyte Colony-Stimulating Factor/therapeutic use ; Humans ; Induction Chemotherapy ; Leukemia, Myeloid, Acute/drug therapy ; Male ; Middle Aged ; Myeloid Progenitor Cells/transplantation ; Neutrophils/physiology ; Prospective Studies |
Chemical Substances | Antifungal Agents ; Granulocyte Colony-Stimulating Factor (143011-72-7) |
Language | English |
Publishing date | 2021-06-22 |
Publishing country | United States |
Document type | Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, U.S. Gov't, Non-P.H.S. |
ZDB-ID | 604914-x |
ISSN | 1527-7755 ; 0732-183X |
ISSN (online) | 1527-7755 |
ISSN | 0732-183X |
DOI | 10.1200/JCO.20.01739 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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