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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

EU Clinical Trials Register

NCT-Nr.: NCT00209209

Leitung: Herr Prof. Dr. med. Martin Dreyling

 

Herr Prof. Dr. med. Martin Dreyling

Klinikum der Universität München

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Informationen zur Studie

Studientherapie

R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) versus R-FC (rituximab, fludarabine, cyclophosphamide)

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

To investigate whether R-FC is associated with a reduction of lymphoma mass measured by the CR rate compared with R-CHOP
To investigate whether maintenance with rituximab prolongs progression-free survival after end of initial chemotherapy in comparison with interferon-alpha maintenance

Sekundäre Ziele der Studie

To compare induction and maintenance groups in terms of secondary outcomes

Studienpopulation

MCL advanced stage older and not suitable for high-dose chemotherapy

Statistik und Patientenzahl

560

Primäre Endpunkte

CR rate
Progression-free survival

Sekundäre Endpunkte

Overall response
Overall survival
Toxicity

Spezifische Infos zum Antrag

Therapie
Biomarker-Programm geplant

Ja

Studiendokumente

    Publikationen

    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

    Follow-up publication of the European MCL Elderly trial

    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

    primary publication of the European MCL Elderly trial