Studienprotokolle

Zevalin-Study Rekrutierung beendet!

15.10.2007 Zevalin-Study Rekrutierung beendet!
DesignProspective, multicenter, non-randomized phase II trial
Primäre ZieleComplete and partial response rate
Sekundäre ZieleProgression-free survival, overall survival, safety and
tolerability of 90Y-ibritumomab tiuxetan
StudienpopulationPatients with histologically confirmed relapsed or refractory
mantle cell lymphoma according to the WHO classification
after / not appropriate for stem cell transplantation
TherapieIn patients with high tumor load, an initial tumor reduction
with 3 cycles Immuno-chemotherapy (R-FC, BMR etc.) and 1
dose of Rituximab is recommended.
Infusion of Rituximab (250 mg/m2, day 1) followed by a
sequential infusions of Rituximab (250 mg/m2, day 8) and a
single dose of 90Y-ibritumomab tiuxetan (0.4 mCi/kg / 0.3
mCi/kg if thrombocytes < 150.000/μl of after autologous
PBSCT, day 8)
Erforderliche Patientenzahl50
Zeitplan2nd quarter 2004 – 4th quarter 2008
ProtokollversionAmendment 2.1
StudienleitungPD Dr. M. Dreyling
Prof. Dr. W. Hiddemann
University Hospital Großhadern/LMU
Dept. of Medicine III
Marchioninistraße 15
D-81377 Munich / GERMANY
Phone: +49-89-4400-72202
Fax: +49-89-4400-72201
e-mail: martin.dreyling@med.uni-muenchen.de
Data centerEuropean MCL Network
Dr. M. Unterhalt
University Hospital Großhadern/LMU
Dept. of Medicine III
Marchioninistraße 15
81377 München / GERMANY
Phone: +49-89-4400-74900/01
Fax: +49-89-4400-77900/01
e-mail: studyce@med.uni-muenchen.de
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