Randomized Cross-Over Trial of Progenitor-Cell Mobilization: High-Dose Cyclophosphamide Plus Granulocyte Colony-Stimulating Factor (G-CSF) Versus Granulocyte-Macrophage Colony-Stimulating Factor Plus G-CSF

• DOI: 10.1200/jco.2000.18.9.1824
• Publication Date: 2017-02-24T07:20:01Z
• Authors: Omer N. Koç; Stanton L. Gerson; Brenda W. Cooper; Mary Laughlin; Howard Meyerson; Leila Kutteh; Robert M. Fox; Emese M. Szekely; Nancy Tainer; Hillard M. Lazarus
• Keywords: Regimen; Plerixafor; Leukapheresis; Mobilization

PURPOSE: Patient response to hematopoietic progenitor-cell mobilizing regimens seems vary considerably, making comparison between difficult. To eliminate this inter-patient variability, we designed a cross-over trial and prospectively compared the number of progenitors mobilized into blood after granulocyte-macrophage colony-stimulating factor (GM-CSF) days 1 12 plus granulocyte (G-CSF) 7 (regimen G) with cyclophosphamide G-CSF 3 14 C) in same patient. PATIENTS AND METHODS: Twenty-nine patients were randomized receive either regimen G or C first (G1 C1, respectively) underwent two leukaphereses. After washout period, then crossed over alternate (C2 G2, additional The content each collection was determined. In addition, toxicity charges tracked. RESULTS: Regimen (n = 50) resulted mobilization more CD34 + cells (2.7-fold/kg/apheresis), erythroid burst-forming units (1.8-fold/kg/apheresis), colony-forming units–granulocyte-macrophage (2.2-fold/kg/apheresis) given 46; paired t test, P < .01 for all comparisons). Compared G, better mobilization, whether it (P .025) second .02). ability achieve target ≥ 2 × 10 6 cells/kg using leukaphereses 50% G1 90% C1. Three seven whom poor had C2. contrast, when (G2), out failed cell dose despite adequate collections Thirty percent (nine 29) admitted hospital because neutropenic fever median duration 4 (range, days). higher cost balanced by yield, resulting equivalent based on per collected. CONCLUSION: We report clinical that used design showing high-dose results GM-CSF tested patient regardless sequence administration, although is associated greater morbidity. Patients who fail can be treated as an effective salvage regimen, whereas are unlikely benefit from subsequent treatment G. allowed detection significant differences small cohort should considered future comparisons regimens.