Studienprotokolle

MCL Younger - Rekrutierung beendet!

29.05.2006 MCL Younger - Rekrutierung beendet!
DesignProspective, multicenter, randomized phase III study
Primäre ZieleTime to treatment failure
Sekundäre ZieleCR rate and overall survival, progression-free survival
Adverse events, serious infectious complications
ZielkriterienTime to treatment failure
Studienpopulation- patients < 65 years
- advanced mantle cell lymphoma (Ann Arbor stage II-IV)
according to the WHO classification
- previously untreated
- WHO performance status < 2 or less
- eligible for myeloablative therapy
Therapiestandard arm:
6 cycles CHOP plus Rituximab followed by myeloablative radiochemotherapy (12 Gray TBI, cyclo 2x 60 mg/m2) and autologous stem cell transplantation
experimental arm:
alternating cycles of 3x CHOP and 3x DHAP plus Rituximab followed by a high dose ARA-C containing myeloablative radiochemotherapy (10 Gray TBI, Ara-C, Melphalan) and autologous stem cell transplantation
Erforderliche Patientenzahl360
Zeitplan4 years (estimation of sequential test)
Protokollversion2.2d (7.6.2004)
StudienleitungProf O. Hermine (chairman)
University Hospital Necker
Dept. of Adult Hematology
149-161 rue de Sèvres
75743 Paris Cedex 15
FRANCE
Phone-No.: 33-1-44-49-52-83
Telefax-No.: 33-1-44-49-52-80
E-mail : hermine@necker.fr

Prof. Dr. W. Hiddemann (co-chairman)
University Hospital Großhadern/LMU
Dept. of Medicine III
Marchioninistr. 15
81377 Munich
GERMANY
Phone-No : 49 89 4400 72550
Telefax: 49 89 4400 75550
E-mail : studyce@med.uni-muenchen.de
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Data CenterGerman Low Grade Lymphoma Study Group
Dr. M. Unterhalt (responsible statistician)
University Hospital Großhadern/LMU
Dept. of Medicine III
Marchioninistraße 15
81377 Munich
GERMANY
Phone-No.: (49) -89-4400-74900/01
Telefax-No.: (49) -89-4400-77900/01
E-Mail:studyce@med.uni-muenchen.de
Participating GroupsGroupe D’Etude Des Lymphomes De l’Adulte (GELA),
German Low Grade Lymphoma Study Group (GLSG),
HOVON and CLSG