TY - JOUR
T1 - Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia
AU - Desai, Pinkal M.
AU - Brown, Janice
AU - Gill, Saar
AU - Solh, Melham M.
AU - Akard, Luke P.
AU - Hsu, Jack W.
AU - Ustun, Celalettin
AU - Andreadis, Charalambos
AU - Frankfurt, Olga
AU - Foran, James M.
AU - Lister, John
AU - Schiller, Gary J.
AU - Wieduwilt, Matthew J.
AU - Pagel, John M.
AU - Stiff, Patrick J.
AU - Liu, Delong
AU - Khan, Irum
AU - Stock, Wendy
AU - Kambhampati, Suman
AU - Tallman, Martin S.
AU - Morris, Lawrence
AU - Edwards, John
AU - Pusic, Iskra
AU - Kantarjian, Hagop M.
AU - Mamelok, Richard
AU - Wong, Alicia
AU - Van Syoc, Rodney
AU - Kellerman, Lois
AU - Panuganti, Swapna
AU - Mandalam, Ramkumar
AU - Abboud, Camille N.
AU - Ravandi, Farhad
N1 - Funding Information:
Supported, in whole or in part, with federal funds from the Biomedical Advanced Research and Development Authority under Contract No. HHSO100201000051C.
Publisher Copyright:
Copyright © 2022 American Society of Clinical Oncology. All rights reserved.
PY - 2021/10/10
Y1 - 2021/10/10
N2 - 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/mL. 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 v 3.90; P 5 .02). Similarly, a trend toward decreased microbiologically defined infections and clinically diagnosed infection in the treatment arm was observed from d9 to d28 (35.6% v 47.5%; P 5 .09), reaching a statistically significant difference from d15 to d28 (6.8% v 27.9%; P 5 .002). Because of this, antibacterial or antifungal use for treatment of an infection was significantly less in the treatment group (d9-d28: 44.1% v 63.9%; P 5 .01). Significantly fewer patients in the treatment arm received empiric antifungals from d9 tod28 (42.4% v 63.9%; P 5 .02) and d15-d28 (42.4% v 62.3%; P 5 .02). Patients in the treatment arm also had 3.2 fewer hospital days compared with control (25.5 v 28.7; P 5 .001). Remission rates and days to absolute neutrophil count recovery were similar in the two groups. No patients in the romyelocel-L plus G-CSF group died because of infection compared with two patients in the control arm. No graft-versus-host disease was observed. 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.
AB - 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/mL. 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 v 3.90; P 5 .02). Similarly, a trend toward decreased microbiologically defined infections and clinically diagnosed infection in the treatment arm was observed from d9 to d28 (35.6% v 47.5%; P 5 .09), reaching a statistically significant difference from d15 to d28 (6.8% v 27.9%; P 5 .002). Because of this, antibacterial or antifungal use for treatment of an infection was significantly less in the treatment group (d9-d28: 44.1% v 63.9%; P 5 .01). Significantly fewer patients in the treatment arm received empiric antifungals from d9 tod28 (42.4% v 63.9%; P 5 .02) and d15-d28 (42.4% v 62.3%; P 5 .02). Patients in the treatment arm also had 3.2 fewer hospital days compared with control (25.5 v 28.7; P 5 .001). Remission rates and days to absolute neutrophil count recovery were similar in the two groups. No patients in the romyelocel-L plus G-CSF group died because of infection compared with two patients in the control arm. No graft-versus-host disease was observed. 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.
UR - http://www.scopus.com/inward/record.url?scp=85118283062&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85118283062&partnerID=8YFLogxK
U2 - 10.1200/JCO.20.01739
DO - 10.1200/JCO.20.01739
M3 - Article
C2 - 34156898
AN - SCOPUS:85118283062
SN - 0732-183X
VL - 39
SP - 3261
EP - 3272
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 29
ER -
