1. Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia
- Author
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Suman Kambhampati, Iskra Pusic, James M. Foran, John G. Edwards, John Lister, Farhad Ravandi, John M. Pagel, Charalambos Andreadis, Camille N. Abboud, Swapna Panuganti, Lois Kellerman, Martin S. Tallman, Richard David Mamelok, Delong Liu, Lawrence E. Morris, Saar Gill, Alicia Wong, Jack W. Hsu, Gary J. Schiller, Pinkal Desai, Hagop M. Kantarjian, Melham M. Solh, Irum Khan, Olga Frankfurt, Rodney Van Syoc, Patrick J. Stiff, Ramkumar Mandalam, Janice M. Brown, Wendy Stock, Luke P. Akard, Celalettin Ustun, and Matthew J Wieduwilt
- Subjects
Male ,Myeloid ,Cancer Research ,Antifungal Agents ,Neutrophils ,030204 cardiovascular system & hematology ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Granulocyte Colony-Stimulating Factor ,Cytotoxic T cell ,Prospective Studies ,Cancer ,Leukemia ,Myeloid leukemia ,Induction Chemotherapy ,Hematology ,Middle Aged ,Leukemia, Myeloid, Acute ,Infectious Diseases ,medicine.anatomical_structure ,Oncology ,6.1 Pharmaceuticals ,030220 oncology & carcinogenesis ,Female ,Open label ,Infection ,Adult ,Clinical Trials and Supportive Activities ,Clinical Sciences ,Oncology and Carcinogenesis ,Acute ,Neutropenia ,03 medical and health sciences ,Rare Diseases ,Clinical Research ,medicine ,Humans ,Oncology & Carcinogenesis ,Myeloid Progenitor Cells ,Aged ,Progenitor ,business.industry ,Evaluation of treatments and therapeutic interventions ,Induction chemotherapy ,medicine.disease ,Cancer research ,business - 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 v 3.90; P = .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 = .09), reaching a statistically significant difference from d15 to d28 (6.8% v 27.9%; P = .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 = .01). Significantly fewer patients in the treatment arm received empiric antifungals from d9 tod28 (42.4% v 63.9%; P = .02) and d15-d28 (42.4% v 62.3%; P = .02). Patients in the treatment arm also had 3.2 fewer hospital days compared with control (25.5 v 28.7; P = .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.
- Published
- 2021