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Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia
- Source :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol 39, iss 29
- Publication Year :
- 2021
- Publisher :
- American Society of Clinical Oncology (ASCO), 2021.
-
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.
- 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
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 39
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi.dedup.....a0ffcaa3359e72993b55cfac9f54aba1