Stem cell collection and hematological recovery in the Fondazione Italiana Linfomi (FIL) MCL0208 clinical trial.
Humans
Lymphoma, Mantle-Cell
/ therapy
Middle Aged
Male
Female
Hematopoietic Stem Cell Mobilization
/ methods
Leukapheresis
/ methods
Aged
Transplantation, Autologous
Adult
Hematopoietic Stem Cell Transplantation
/ methods
Lenalidomide
/ administration & dosage
Hematopoietic Stem Cells
/ metabolism
Antigens, CD34
/ metabolism
Italy
Autologous stem cell transplantation (ASCT)
Hematological recovery
Leukapheresis (LK)
Mantle cell lymphoma (MCL)
Peripheral blood stem cells (PBSC)
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
23 Jul 2024
23 Jul 2024
Historique:
received:
14
02
2024
accepted:
17
07
2024
medline:
24
7
2024
pubmed:
24
7
2024
entrez:
23
7
2024
Statut:
epublish
Résumé
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 × 10
Identifiants
pubmed: 39043871
doi: 10.1038/s41598-024-67906-w
pii: 10.1038/s41598-024-67906-w
doi:
Substances chimiques
Lenalidomide
F0P408N6V4
Antigens, CD34
0
Types de publication
Journal Article
Clinical Trial, Phase III
Langues
eng
Sous-ensembles de citation
IM
Pagination
16946Informations de copyright
© 2024. The Author(s).
Références
Swerdlow, S.H. World Health Organization, International Agency for Research on Cancer. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. https://publications.iarc.fr/Book-And-Report-Series/Who-Classification-Of-Tumours/WHO-Classification-Of-Tumours-Of-Haematopoietic-And-Lymphoid-Tissues-2017 . Accessed October 6, 2022.
Le Gouill, S. et al. Rituximab after autologous stem-cell transplantation in mantle-cell lymphoma. N. Engl. J. Med. 377(13), 1250–1260. https://doi.org/10.1056/nejmoa1701769 (2017).
doi: 10.1056/nejmoa1701769
pubmed: 28953447
Dreyling, M. et al. Efficacy and safety of ibrutinib combined with standard first-line treatment or as substitute for autologous stem cell transplantation in younger patients with mantle cell lymphoma: Results from the randomized triangle trial by the European MCL network. Blood. 140(Supplement 1), 1–3. https://doi.org/10.1182/blood-2022-163018 (2022).
doi: 10.1182/blood-2022-163018
Ladetto, M. et al. Lenalidomide maintenance after autologous haematopoietic stem-cell transplantation in mantle cell lymphoma: Results of a Fondazione Italiana Linfomi (FIL) multicentre, randomised, phase 3 trial. Lancet Haematol. 8(1), e34–e44. https://doi.org/10.1016/S2352-3026(20)30358-6 (2021).
doi: 10.1016/S2352-3026(20)30358-6
pubmed: 33357480
Ferrero, S. et al. Punctual and kinetic MRD analysis from the Fondazione Italiana Linfomi MCL0208 phase 3 trial in mantle cell lymphoma. Blood. 140(12), 1378–1389. https://doi.org/10.1182/blood.2021014270 (2022).
doi: 10.1182/blood.2021014270
pubmed: 35737911
pmcid: 9507010
van der Velden, V. H. J. et al. Analysis of minimal residual disease by Ig/TCR gene rearrangements: Guidelines for interpretation of real-time quantitative PCR data. Leukemia. 21(4), 604–611. https://doi.org/10.1038/sj.leu.2404586 (2007).
doi: 10.1038/sj.leu.2404586
pubmed: 17287850
Lausen, B. & Schumacher, M. Maximally selected rank statistics. Biometrics. 48(1), 73. https://doi.org/10.2307/2532740 (1992).
doi: 10.2307/2532740
Gianni, A. M. et al. Long-term remission in mantle cell lymphoma following high-dose sequential chemotherapy and in vivo rituximab-purged stem cell autografting (R-HDS regimen). Blood. 102(2), 749–755. https://doi.org/10.1182/blood-2002-08-2476 (2003).
doi: 10.1182/blood-2002-08-2476
pubmed: 12663455
Magni, M. et al. High-dose sequential chemotherapy and in vivo rituximab-purged stem cell autografting in mantle cell lymphoma: A 10-year update of the R-HDS regimen. Bone Marrow Transplant. 43(6), 509–511. https://doi.org/10.1038/bmt.2008.349 (2009).
doi: 10.1038/bmt.2008.349
pubmed: 18955979
Hermine, O. et al. Addition of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): A randomised, open-label, phase 3 trial of the European Mantle Cell Lymphoma N. Lancet. 388(10044), 565–575. https://doi.org/10.1016/S0140-6736(16)00739-X (2016).
doi: 10.1016/S0140-6736(16)00739-X
pubmed: 27313086
Le Gouill, S. et al. Molecular response after obinutuzumab plus high-dose cytarabine induction for transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101): A phase 2 trial of the LYSA group. Lancet Haematol. 7(11), e798–e807. https://doi.org/10.1016/S2352-3026(20)30291-X (2020).
doi: 10.1016/S2352-3026(20)30291-X
pubmed: 32971036
Brown, J. R. et al. Long-term survival after autologous bone marrow transplantation for follicular lymphoma in first remission. Biol. Blood Marrow Transplant. 13(9), 1057–1065. https://doi.org/10.1016/j.bbmt.2007.05.012 (2007).
doi: 10.1016/j.bbmt.2007.05.012
pubmed: 17697968
pmcid: 4147857
Magni, M. et al. Successful in vivo purging of CD34-containing peripheral blood harvests in mantle cell and indolent lymphoma: Evidence for a role of both chemotherapy and rituximab infusion. Blood. 96(3), 864–869. https://doi.org/10.1182/blood.v96.3.864 (2000).
doi: 10.1182/blood.v96.3.864
pubmed: 10910898
Ladetto, M. A comprehensive and systematic analysis of minimal residual disease (MRD) monitoring in follicular lymphoma: Results from the Fondazione Italiana Linfomi (FIL) FOLL12 Trial. December 2021. https://ash.confex.com/ash/2021/webprogram/Paper146773.html . Accessed November 5, 2021.
Ferrero, S. et al. Candidate germline biomarkers of lenalidomide efficacy in mantle cell lymphoma: The FIL MCL0208 trial. Blood Adv. https://doi.org/10.1182/bloodadvances.2022009504 (2023).
doi: 10.1182/bloodadvances.2022009504
pubmed: 37276080
pmcid: 10407138
Husby, S. et al. Clinical impact of clonal hematopoiesis in patients with lymphoma undergoing ASCT: A national population-based cohort study. Leukemia. 34(12), 3256–3268. https://doi.org/10.1038/s41375-020-0795-z (2020).
doi: 10.1038/s41375-020-0795-z
pubmed: 32203146
Lackraj, T. et al. Clinical significance of clonal hematopoiesis in the setting of autologous stem cell transplantation for lymphoma. Am. J. Hematol. 97(12), 1538–1547. https://doi.org/10.1002/ajh.26726 (2022).
doi: 10.1002/ajh.26726
pubmed: 36087071
Hazenberg, C. L. E. et al. Clonal hematopoiesis in patients with stem cell mobilization failure: A nested case-control study. Blood Adv. 7(7), 1269–1278. https://doi.org/10.1182/bloodadvances.2022007497 (2023).
doi: 10.1182/bloodadvances.2022007497
pubmed: 36219593
Ragaini, S., Galli, A., Genuardi, E., Gandossini, M., Alessandria, B. & Maria Civita, A. et al. Myeloid clonal hematopoiesis affects outcome in younger mantle cell lymphoma patients: Updated results from the Fondazione Italiana Linfomi MCL0208 clinical trial. Abstract release date: 05/14/24. EHA Library; 419334; P1247.
Hermine, O. et al. High-dose cytarabine and autologous stem-cell transplantation in mantle cell lymphoma: Long-term follow-up of the randomized mantle cell lymphoma younger trial of the European mantle cell lymphoma network. J. Clin. Oncol. 41(3), 479–484. https://doi.org/10.1200/JCO.22.01780 (2023).
doi: 10.1200/JCO.22.01780
pubmed: 36469833