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
Affiliations
- Michele Clerico
- Division of Hematology, AOU “Città della Salute e della Scienza di Torino”
- Simone Ferrero
- Division of Hematology, AOU “Città della Salute e della Scienza di Torino”
- Beatrice Alessandria
- Department of Molecular Biotechnologies and Health Sciences, University of Torino
- Gian Maria Zaccaria
- Department of Electrical and Information Engineering (DEI), Polytechnic University of Bari
- Elisa Genuardi
- Department of Molecular Biotechnologies and Health Sciences, University of Torino
- Simone Ragaini
- Division of Hematology, AOU “Città della Salute e della Scienza di Torino”
- Rita Tavarozzi
- SC Ematologia Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
- Federica Cavallo
- Division of Hematology, AOU “Città della Salute e della Scienza di Torino”
- Stefan Hohaus
- Institute of Hematology, Università Cattolica del Sacro Cuore and Fondazione Policlinico Univeristario A. Gemelli
- Gerardo Musuraca
- IRCCS, IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori “Dino Amadori”
- Angelo Michele Carella
- Department of Hematology and Bone Marrow Transplant, IRCSS Casa Sollievo Della Sofferenza
- Caterina Stelitano
- Department of Hematology, Azienda Ospedaliera Bianchi Melacrino Morelli
- Monica Tani
- UOC di Ematologia, Ospedale S. Maria delle Croci
- Gianluca Gaidano
- Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont
- Jacopo Olivieri
- Clinica Ematologica, Azienda Sanitaria Universitaria Integrata di Udine
- Sara Veronica Usai
- Ematologia e CTMO, Ospedale Businco
- Sara Galimberti
- Division of Hematology, University Hospital of Pisa
- Francesca Re
- Division of Immuno-Haematology, AOU Parma
- Michael Mian
- Innovation, Research and Teaching Service (SABES-ASDAA), Teaching Hospital of the Paracelsus Medical Private University (PMU)
- Claudia Castellino
- Division of Hematology, Azienda Ospedaliera S. Croce e Carle
- Vincenzo Pavone
- Ospedale Pia Fondazione Cardinale Panico
- Andrea Evangelista
- Unit of Clinical Epidemiology, AOU “Città della Salute e della Scienza di Torino” and CPO Piemonte
- Benedetto Bruno
- Division of Hematology, AOU “Città della Salute e della Scienza di Torino”
- Sergio Cortelazzo
- Oncology Unit, Humanitas/Gavazzeni Clinic
- Roberto Passera
- Department of Medical Sciences, University of Torino
- Marco Ladetto
- SC Ematologia Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
- DOI
- https://doi.org/10.1038/s41598-024-67906-w
- Journal volume & issue
-
Vol. 14,
no. 1
pp. 1 – 9
Abstract
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.
Keywords
- Mantle cell lymphoma (MCL)
- Autologous stem cell transplantation (ASCT)
- Peripheral blood stem cells (PBSC)
- Leukapheresis (LK)
- Hematological recovery