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Desai PM, Brown J, Gill S, et al. Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia. J Clin Oncol. 2021;39(29):3261-3272doi: 10.1200/JCO.20.01739.
Desai, P. M., Brown, J., Gill, S., Solh, M. M., Akard, L. P., Hsu, J. W., Ustun, C., Andreadis, C., Frankfurt, O., Foran, J. M., Lister, J., Schiller, G. J., Wieduwilt, M. J., Pagel, J. M., Stiff, P. J., Liu, D., Khan, I., Stock, W., Kambhampati, S., Tallman, M. S., Morris, L., Edwards, J., Pusic, I., Kantarjian, H. M., Mamelok, R., Wong, A., Van Syoc, R., Kellerman, L., Panuganti, S., Mandalam, R., Abboud, C. N., & Ravandi, F. (2021). 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, 39(29), 3261-3272. https://doi.org/10.1200/JCO.20.01739
Desai, Pinkal M, et al. "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 vol. 39,29 (2021): 3261-3272. doi: https://doi.org/10.1200/JCO.20.01739
Desai PM, Brown J, Gill S, Solh MM, Akard LP, Hsu JW, Ustun C, Andreadis C, Frankfurt O, Foran JM, Lister J, Schiller GJ, Wieduwilt MJ, Pagel JM, Stiff PJ, Liu D, Khan I, Stock W, Kambhampati S, Tallman MS, Morris L, Edwards J, Pusic I, Kantarjian HM, Mamelok R, Wong A, Van Syoc R, Kellerman L, Panuganti S, Mandalam R, Abboud CN, Ravandi F. Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia. J Clin Oncol. 2021 Oct 10;39(29):3261-3272. doi: 10.1200/JCO.20.01739. Epub 2021 Jun 22. PMID: 34156898; PMCID: PMC8500663.
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J Clin Oncol. 2021 Oct 10;39(29):3261-3272. doi: 10.1200/JCO.20.01739. Epub 2021 Jun 22.

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

Pinkal M Desai, Janice Brown, Saar Gill, Melham M Solh, Luke P Akard, Jack W Hsu, Celalettin Ustun, Charalambos Andreadis, Olga Frankfurt, James M Foran, John Lister, Gary J Schiller, Matthew J Wieduwilt, John M Pagel, Patrick J Stiff, Delong Liu, Irum Khan, Wendy Stock, Suman Kambhampati, Martin S Tallman, Lawrence Morris, John Edwards, Iskra Pusic, Hagop M Kantarjian, Richard Mamelok, Alicia Wong, Rodney Van Syoc, Lois Kellerman, Swapna Panuganti, Ramkumar Mandalam, Camille N Abboud, Farhad Ravandi

Affiliations

  1. Weill Cornell Medical College, New York, NY.
  2. Stanford University Medical Center, Stanford, CA.
  3. University of Pennsylvania, Philadelphia, PA.
  4. Northside Hospital, Atlanta, GA.
  5. Indiana Blood and Marrow Transplantation, Indianapolis, IN.
  6. University of Florida, Gainesville, FL.
  7. University of Minnesota, St Paul, MN.
  8. University of California San Francisco, San Francisco, CA.
  9. Northwestern University, Chicago, IL.
  10. Mayo Clinic, Jacksonville, FL.
  11. Allegheny Health Network, Pittsburgh, PA.
  12. David Geffen School of Medicine at UCLA, Los Angeles, CA.
  13. Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK.
  14. Swedish Cancer Institute, Seattle, WA.
  15. Loyola University Stritch School of Medicine, Maywood, IL.
  16. New York Medical College, Hawthorne, NY.
  17. University of Illinois Cancer Center, Chicago, IL.
  18. University of Chicago, Chicago, IL.
  19. Kansas City Veterans Affairs Medical Center, Kansas City, MO.
  20. Memorial Sloan Kettering Cancer Center, New York, NY.
  21. Washington University, St Louis, MO.
  22. The University of Texas MD Anderson Cancer Center, Houston, TX.
  23. Cellerant Therapeutics, San Carlos, CA.

PMID: 34156898 PMCID: PMC8500663 DOI: 10.1200/JCO.20.01739

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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