Efficacy of maintenance therapy with rituximab after induction chemotherapy (R-CHOP vs. R-FC) for elderly patients with mantle cell lymphoma not suitable for autologous stem cell transplantation
Kategorie: Indolente Lymphome/MCL
Initial cytoreductive therapy: randomisation between
8 x CHOP-21 + rituximab versus 6 x FC-28 + rituximab
For CR/PR patients second randomisation between
2-monthly rituximab 375 mg/m2 versus Interferon-alpha 3x 3M IU or Peg-Intron 1 g/kg weekly until progression
Abgeschlossen
Mantelzell- Lymphom
560
> 60 Jahre
Phase III
1. To test in elderly patients with advanced mantle cell lymphoma, whether rituximab plus a combination of fludarabine with cyclophosphamide (6 FC cycles) results in a higher reduction of lymphoma mass measured by the percentage of CR than rituximab combined with the standard chemotherapy scheme (8 CHOP cycles).
2. To compare maintenance therapy with rituximab with maintenance with interferon-alpha or pegylated interferon for progression free survival, after 2 different regimens of induction chemo-immunotherapy in elderly patients with mantle cell lymphoma.
Patients with histologically confirmed mantle cell lymphoma, advanced stages II-IV, previously untreated, 65 years and older or 60-65 if not eligible for high dose chemotherapy
rate of complete remissions (CR rate)
progression-free survival (PFS)
overall response rate (ORR)
overall survival (OS)
toxicity
minimal residual disease (MRD)
Ja
16.09.2024
Khouja M, Jiang L, Pal K, Stewart PJ, Regmi B, Schwarz M, Klapper W, Alig SK, Darzentas N, Kluin-Nelemans HC, Hermine O, Dreyling M, Gonzalez de Castro D, Hoster E, Pott C
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Hoster E, Delfau-Larue MH, Macintyre E, Jiang L, Stilgenbauer S, Vehling-Kaiser U, Salles G, Thieblemont C, Tilly H, Wirths S, Feugier P, Hubel K, Schmidt C, Ribrag V, Kluin-Nelemans JC, Dreyling M, Pott C
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Scheubeck G, Jiang L, Hermine O, Kluin-Nelemans HC, Schmidt C, Unterhalt M, Rosenwald A, Klapper W, Evangelista A, Ladetto M, Jerkeman M, Ferrero S, Dreyling M, Hoster E
31.12.2021
Zaccaria GM, Ferrero S, Hoster E, Passera R, Evangelista A, Genuardi E, Drandi D, Ghislieri M, Barbero D, Del Giudice I, Tani M, Moia R, Volpetti S, Cabras MG, Di Renzo N, Merli F, Vallisa D, Spina M, Pascarella A, Latte G, Patti C, Fabbri A, Guarini A, Vitolo U, Hermine O, Kluin-Nelemans HC, Cortelazzo S, Dreyling M, Ladetto M
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Thurner L, Fadle N, Bittenbring JT, Regitz E, Schuck R, Cetin O, Stuhr A, Rixecker T, Murawski N, Poeschel V, Kaddu-Mulindwa D, Preuss KD, Stilgenbauer S, Hermine O, Kluin-Nelemans HC, Hartmann S, Dreyling M, Pott C, Bewarder M,* Hoster E*
07.07.2020
Roider T, Wang X, Huttl K, Muller-Tidow C, Klapper W, Rosenwald A, Stewart JP, de Castro DG, Dreger P, Hermine O, Kluin-Nelemans HC, Grabe N, Dreyling M, Pott C, Ott G, Hoster E, Dietrich S
20.01.2020
Hanneke C Kluin-Nelemans, Eva Hoster, Olivier Hermine, Jan Walewski, Christian H Geisler, Marek Trneny, Stephan Stilgenbauer, Florian Kaiser, Jeanette K Doorduijn, Gilles Salles, Michal Szymczyk, Hervé Tilly, Lothar Kanz, Christian Schmidt, Pierre Feugier, Catherine Thieblemont, Josée M Zijlstra, Vincent Ribrag, Wolfram Klapper, Christiane Pott, Michael Unterhalt , Martin H Dreyling
10.08.2018
Rauert-Wunderlich H, Mottok A, Scott DW, Rimsza LM, Ott G, Klapper W, Unterhalt M, Kluin-Nelemans HC, Hermine O, Hartmann S, Thorns C, Rymkiewicz G, Holte H, Dreyling M, Hoster E*, Rosenwald A*
01.12.2017
Aukema, S. M.*, Hoster, E.*, Rosenwald, A., Canoni, D., Delfau-Larue, M. H., Rymkiewicz, G., Thorns, C., Hartmann, S., Kluin-Nelemans, H., Hermine, O., Dreyling, M.*, Klapper, W.*
01.03.2016
Cheminant M, Derrieux C, Touzart A, Schmit S, Grenier A, Trinquand A, Delfau-Larue MH, Lhermitte L, Thieblemont C, Ribrag V, Cheze S, Sanhes L, Jardin F, Lefrere F, Delarue R, Hoster E, Dreyling M, Asnafi V, Hermine O, Macintyre E
29.02.2016
Hoster E, Rosenwald A, Berger F, Bernd HW, Hartmann S, Loddenkemper C, Barth TF, Brousse N, Pileri S, Rymkiewicz G, Kodet R, Stilgenbauer S, Forstpointner R, Thieblemont C, Hallek M, Coiffier B, Vehling-Kaiser U, Bouabdallah R, Kanz L, Pfreundschuh M, Schmidt C, Ribrag V, Hiddemann W, Unterhalt M, Kluin-Nelemans JC, Hermine O, Dreyling MH, Klapper W
31.03.2014
Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M
09.08.2012
H C Kluin-Nelemans, E Hoster, O Hermine, J Walewski, M Trneny, C H Geisler, S Stilgenbauer, C Thieblemont, U Vehling-Kaiser, J K Doorduijn, B Coiffier, R Forstpointner, H Tilly, L Kanz, P Feugier, M Szymczyk, M Hallek, S Kremers, G Lepeu, L Sanhes, J M Zijlstra, R Bouabdallah, P J Lugtenburg, M Macro, M Pfreundschuh, V Procházka, F Di Raimondo, V Ribrag, M Uppenkamp, M André, W Klapper, W Hiddemann, M Unterhalt, M H Dreyling
01.04.2008
Bottcher S, Ritgen M, Buske S, Gesk S, Klapper W, Hoster E, Hiddemann W, Unterhalt M, Dreyling M, Siebert R, Kneba M, Pott C
