Priming with r-metHuSCF and filgrastim or chemotherapy and filgrastim in patients with malignant lymphomas: a randomized phase II pilot study of mobilization and engraftment

Bone Marrow Transplant. 2011 Jan;46(1):44-51. doi: 10.1038/bmt.2010.84. Epub 2010 May 3.

Abstract

SCF has been shown to synergize with G-CSF to mobilize CD34(+) PBPCs. In this study we report results from this combination after a phase II trial of 32 patients with malignant lymphoma randomized to receive recombinant methionyl human SCF (ancestim, r-metHuSCF) in combination with recombinant methionyl human G-CSF (filgrastim, r-metHuG-CSF) (experimental arm A) or routine chemotherapy plus filgrastim (conventional arm B). The primary objective was to evaluate the side effects and toxicity during priming and mobilization. The secondary objectives were efficacy by the level of blood-circulating PBPCs, the number of harvest days and the time to three-lineage engraftment after autografting. First, during priming 5 patients had 8 serious events, 4 in each arm. A summary of all adverse events revealed 30 (94%) patients suffering from 132 events of all grading. Second, neutropenia and thrombocytopenia was documented in arm B. Third, 9/14 (64%) patients in arm A reached the target of 5 million CD34(+) cells/kg body weight (bw) compared with 13/15 (87%) in arm B. The results represent the first randomized trial of growth factor plus chemotherapy priming and indicate that a formal phase III trial very unlikely may challenge chemotherapy plus r-metHuG-CSF priming in candidates for high-dose therapy.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antigens, CD34 / blood
  • Drug Therapy, Combination / adverse effects
  • Female
  • Filgrastim
  • Graft Survival / drug effects*
  • Granulocyte Colony-Stimulating Factor / adverse effects
  • Granulocyte Colony-Stimulating Factor / therapeutic use*
  • Hematopoietic Stem Cell Mobilization / adverse effects
  • Hematopoietic Stem Cell Mobilization / methods*
  • Humans
  • Lymphoma / blood
  • Lymphoma / therapy*
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Neutropenia / prevention & control
  • Peripheral Blood Stem Cell Transplantation* / adverse effects
  • Pilot Projects
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Stem Cell Factor / adverse effects
  • Stem Cell Factor / analogs & derivatives*
  • Stem Cell Factor / therapeutic use
  • Thrombocytopenia / chemically induced
  • Thrombocytopenia / prevention & control
  • Transplantation Conditioning / adverse effects
  • Transplantation Conditioning / methods*
  • Transplantation, Autologous / adverse effects
  • Young Adult

Substances

  • Antigens, CD34
  • Recombinant Proteins
  • Stem Cell Factor
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim
  • ancestim