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Can Romyelocel-L Plus G-CSF Reduce Infections in Patients With AML?

By: Justine Landin, PhD
Posted: Tuesday, August 31, 2021

The high risk of infection and neutropenia observed in patients with acute myeloid leukemia (AML) following standard cytotoxic induction chemotherapy may be ameliorated through the allogenic myeloid progenitor cell product romyelocel-L in addition to granulocyte colony-stimulating factor (G-CSF), according to Farhad Ravandi, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues. The findings of this phase II, multicenter, open-label, prospective study were published in the Journal of Clinical Oncology.

“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 acute myeloid leukemia undergoing induction therapy,” stated the study investigators.

Patients aged 55 or older with newly diagnosed AML undergoing induction chemotherapy were enrolled (n = 163). Patients were randomly assigned to one of two groups. On the first day of chemotherapy, the treatment group received romyelocel-L infusions on day 9 in addition to G-CSF on day 14. The control group received G-CSF monotherapy on day 14, until the absolute neutrophil count reached 500/mL.

The average time spent in febrile episodes appeared to be reduced in patients who received romyelocel-L and G-CSF (2.36 days) compared with G-CSF monotherapy (3.90 days), particularly from days 15 to 28 (P = .02). Further, the treatment group was found to be four times less likely to develop infection (6.8%) compared with the control group (27.9%) from days 15 to 28 (P = .002). Patients who received combination therapy, compared with monotherapy, were also reported to be less likely to be hospitalized (P = .001) and to receive empiric antifungals (P = .02).

Remission rates and the time to reach recovery of absolute neutrophil count were not different between groups. Graft-versus-host disease was unobserved. Unfortunately, two patients in the control group, but no patients in the treatment group, died due to infection.

Disclosure: For full disclosures of the study authors, visit ascopubs.org.



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