Studienprotokolle

MCL Elderly - Rekrutierung beendet!

29.05.2007 MCL Elderly - Rekrutierung beendet!
DesignProspective, multicenter, randomised phase III trial of the European MCL Network
Primäre ZieleReduction of lymphoma mass measured by the CR rate
Progression-free survival after end of initial chemotherapy
Sekundäre ZieleOverall survival after start/end of initial therapy
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
TherapieInitial 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-a 3x 3M IU or Peg-Intron 1 mg/kg weekly
until progression
Erforderliche PatientenzahlMax. 570 patients
Zeitplan4-6 years
Protokollversion2.2 (23.12.2003)
StudienleitungProf. Dr. J.C. Kluin-Nelemans (chairman)
University Hospital Groningen
P.O. Box 30.001
9700 RB Groningen, The Netherlands
Phone: +31-50-3612354
Fax: +31-50-3614862
E-mail: j.c.kluin-nelemans@int.azg.nl

PD Dr. M. Dreyling (co-chairman)
University Hospital Grobhadern/LMU
Dept. of Medicine III
Marchioninistrabe 15
D-81377 Munich, Germany
Phone: +49-89-4400-72550
Fax: +49-89-4400-75550
E-mail: martin.dreyling@med.uni-muenchen.de
Participating GroupsCLSG, GELA, GLSG, HOVON and Nordic Lymphoma Group
Data-CenterEuropean MCL Network
Dr. M. Unterhalt
Dept. of Hematology University Hospital Grobhadern/LMU
Dept. of Medicine III
Marchioninistraße 15
D-81377 Munich, Germany
Phone: +49-89-4400-74900/01
Fax: +49-89-4400-77900/01
E-mail: studyce@med.uni-muenchen.de
Dokumente Download: European MCL elderly V2.5 20160203 VIII-Patinformation_V3.0_deutsche Zentren.pdf
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