Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce
Pinkal M Desai1, Janice Brown2, Saar Gill3
1Weill Cornell Medical College, New York, NY.
Summary
Romyelocel-L reduced febrile episodes and infections in acute myeloid leukemia (AML) patients undergoing chemotherapy. This allogeneic myeloid progenitor cell therapy may offer a new option to decrease infections and hospitalizations during AML induction.
Area of Science:
- Hematology
- Oncology
- Cell Therapy
Background:
- Standard chemotherapy for acute myeloid leukemia (AML) causes prolonged neutropenia, increasing infection risk.
- Romyelocel-L is an investigational allogeneic myeloid progenitor cell product designed to mitigate infection risk during induction chemotherapy.
Purpose of the Study:
- To evaluate the efficacy of romyelocel-L in reducing infection incidence and duration in elderly patients with de novo AML receiving induction chemotherapy.
Main Methods:
- A randomized trial involving 163 patients (120 evaluable) with de novo AML (age ≥ 55 years).
- Patients received either romyelocel-L plus granulocyte colony-stimulating factor (G-CSF) or G-CSF alone until neutrophil recovery.
- Primary endpoints included days with febrile episodes, infection rates, and hospitalization duration.
Main Results:
- The romyelocel-L group had significantly fewer days with febrile episodes (2.36 vs 3.90; P=.02) and infections from day 15-28 (6.8% vs 27.9%; P=.002).
- Antimicrobial use and hospital days were significantly reduced in the romyelocel-L arm (3.2 fewer days; P=.001).
- Remission rates and neutrophil recovery times were similar between groups; no graft-versus-host disease was observed.
Conclusions:
- Romyelocel-L administration led to a decreased incidence of infections, reduced antimicrobial use, and shorter hospitalizations in AML patients.
- Romyelocel-L represents a potential new therapeutic option for managing infections in patients undergoing AML induction therapy.
