Clinical Intergroup – Description
The Clinical Intergroup working party was founded in 1996 and is currently involving following national study groups (representatives in brackets):
- CLSG (M. Trneny, Prag/Czech Republic)
- EORTC Lymphoma Group (H. Kluin-Nelemans, Groningen/Netherlands)
- GELA (O. Hermine, Paris/France)
- GLSG (W. Hiddemann/Germany)
- GOELAMS (R. Gressin, Grenoble/France)
- HOVON (M. van t’Veer, Rotterdam/Netherlands)
- Israelian Study group (O. Shpilberg, Petah-Tiqva/Israel)
- Nordic Lymphoma Group (C. Geissler, Copenhagen/Denmark)
- OSHO (M. Herold, Erfurt/Germany)
- PLRG (J. Walewski, Warzawa/Poland)
- SAKK (N. Ketterer, Lausanne)
Due to the delayed international acceptance of the subentity of mantle
cell lymphoma, in a first retrospective survey, this group collected
the clinical data of 592 patients with MCL. This retrospective analysis
confirmed the dismal prognosis of MCL with a median survival of 3 years
and virtually not long term survivors. Even more interesting, conventional
chemotherapy was not able to improve the biological course of the disease.
In the subsequent first generation of therapeutic study, important clinical results
could be achieved by the clinical cooperation group. In close collaboration with
the GLSG, analysis of more than 200 patients recruited within this trial confirmed
that a combined immuno-chemotherapy results in a significantly improved response
and survival rates in relapsed mantle cell lymphomas.
In the first European trial on high dose therapy in malignant lymphoma, the European
MCL Intergroup working party could prove that an intensive consolidation with
autologous stem cell transplantation results in an extended progression-free
survival based on the evaluation of more than 200 patients treated within the
study.
Currently, following studies have been initiated:
Primary therapy:
- R-CHOP followed by myeloablative consolidation vs. R-CHOP/R-DHAP followed by high dose Ara-C therapy (patients < 65 years, randomized phase III)
- R-CHOP vs. R-FC followed by Rituximab maintenance vs. observation (patients > 65 years, randomized phase III)
Relapse:
- FCM+/-Rituximab followed by observation vs. Rituximab maintenance (randomized phase III in collaboration with the GLSG)
- Radioimmunotherapy with a Yttrium-labeled anti CD20 antibody (phase II)
- Allogeneic transplantation with dose reduced conditioning (phase II)
Objectives
Built on the established infrastructure of the Clinical MCL Intergroup Working
Party this workpackage aims at the evaluation of promising, new treatment
options in MCL to improve the clinical course of this aggressive lymphoma
in prospective, randomized studies. Previous trial generations of the European
collaboration of clinicians has, for the first time, confirmed the superiority
of innovative treatment options. In the current study generation, further
optimized application of myeloablative radiochemotherapy as well as combined
immuno-chemotherapy should be achieved.
This setting of a controlled study is a crucial point for the evaluation of new
predictive and prognostic markers.