TEST | German Lymphoma Alliance

European MCL Elderly

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

Clinical Trials Register (clinicaltrials.gov)

Leitung: Herr Prof. Dr. med. Martin Dreyling

Herr Prof. Dr. med. Martin Dreyling

Klinikum der Universität München

E-Mail senden

Informationen zur Studie

Studientherapie

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

Studienstatus

Abgeschlossen

Indikation

Mantelzell- Lymphom

Anzahl Patienten

560

Alter der Patienten

> 60 Jahre

Studienphase

Phase III

Zusatzinformationen

Allgemeine Infos zum Antrag

Primäres Ziel der Studie

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.

Studienpopulation

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

Primäre Endpunkte

rate of complete remissions (CR rate)
progression-free survival (PFS)

Sekundäre Endpunkte

overall response rate (ORR)
overall survival (OS)
toxicity
minimal residual disease (MRD)

Spezifische Infos zum Antrag

Therapie

Biomarker-Programm geplant

Publikationen

Comprehensive genetic analysis by targeted sequencing identifies risk factors and predicts patient outcome in Mantle Cell Lymphoma: results from the EU-MCL network trials

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

DOI: 10.1038/s41375-024-02375-8

Predictive Value of Minimal Residual Disease for Efficacy of Rituximab Maintenance in Mantle Cell Lymphoma: Results From the European Mantle Cell Lymphoma Elderly Trial

22.11.2023

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

DOI: 10.1200/JCO.23.00899

Clinical outcome of Mantle Cell Lymphoma patients with high-risk disease (high-risk MIPI-c or high p53 expression)

26.07.2023

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

DOI: 10.1038/s41375-023-01977-y

A Clinical Prognostic Model Based on Machine Learning from the Fondazione Italiana Linfomi (FIL) MCL0208 Phase III Trial

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

DOI: 10.3390/cancers14010188

LRPAP1 autoantibodies in mantle cell lymphoma are associated with superior outcome

10.06.2021

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*

DOI: 10.1182/blood.2020008835

The impact of SAMHD1 expression and mutation status in mantle cell lymphoma: An analysis of the MCL Younger and Elderly trial

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

DOI: 10.1002/ijc.33202

Treatment of Older Patients With Mantle Cell Lymphoma (MCL): Long-Term Follow-Up of the Randomized European MCL Elderly Trial

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

DOI: 10.1200/JCO.19.01294

Validation of the MCL35 gene expression proliferation assay in randomized trials of the European Mantle Cell Lymphoma Network

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*

DOI: 10.1111/bjh.15519

Expression of TP53 is associated with outcome of MCL independent of MIPI and Ki-67 in trials of the European-MCL Network

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.*

DOI: 10.1182/blood-2017-07-797019

Minimal residual disease monitoring by 8-color flow cytometry in mantle cell lymphoma: an EU-MCL and LYSA study

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

DOI: 10.3324/haematol.2015.134957

Prognostic Value of Ki-67 Index, Cytology, and Growth Pattern in Mantle-Cell Lymphoma: Results From Randomized Trials of the European Mantle Cell Lymphoma Network

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

DOI: 10.1200/JCO.2015.63.8387

Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network

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

DOI: 10.1200/JCO.2013.52.2466

Treatment of older patients with mantle-cell lymphoma

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

DOI: 10.1056/NEJMoa1200920

Minimal residual disease detection in mantle cell lymphoma: methods and significance of four-color flow cytometry compared to consensus IGH-polymerase chain reaction at initial staging and for follow-up examinations

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

DOI: 10.3324/haematol.11267