Scientific Reports (Jul 2024)

Stem cell collection and hematological recovery in the Fondazione Italiana Linfomi (FIL) MCL0208 clinical trial

  • Michele Clerico,
  • Simone Ferrero,
  • Beatrice Alessandria,
  • Gian Maria Zaccaria,
  • Elisa Genuardi,
  • Simone Ragaini,
  • Rita Tavarozzi,
  • Federica Cavallo,
  • Stefan Hohaus,
  • Gerardo Musuraca,
  • Angelo Michele Carella,
  • Caterina Stelitano,
  • Monica Tani,
  • Gianluca Gaidano,
  • Jacopo Olivieri,
  • Sara Veronica Usai,
  • Sara Galimberti,
  • Francesca Re,
  • Michael Mian,
  • Claudia Castellino,
  • Vincenzo Pavone,
  • Andrea Evangelista,
  • Benedetto Bruno,
  • Sergio Cortelazzo,
  • Roberto Passera,
  • Marco Ladetto

DOI
https://doi.org/10.1038/s41598-024-67906-w
Journal volume & issue
Vol. 14, no. 1
pp. 1 – 9

Abstract

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Abstract In the frontline high-dose phase 3 FIL-MCL0208 trial (NCT02354313), 8% of enrolled mantle cell lymphoma (MCL) patients could not be randomised to receive lenalidomide (LEN) maintenance vs observation after autologous stem cell transplantation (ASCT) due to inadequate hematological recovery and 52% of those who started LEN, needed a dose reduction due to toxicity. We therefore focused on the role played by CD34 + hematopoietic stem cells (PBSC) harvesting and reinfusion on toxicity and outcome. Overall, 90% (n = 245) of enrolled patients who underwent the first leukapheresis collected ≥ 4 × 106 PBSC/kg, 2.6% (n = 7) mobilized 10 days) was associated with a worse outcome, both in terms of PFS and OS. In conclusion, although the harvesting procedures proved feasible for younger MCL patients, long-lasting cytopenia following ASCT remains a significant issue: this can hinder the administration of effective maintenance therapies, potentially increasing the relapse rate and negatively affecting survival outcomes.

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