Studienprotokolle

R-HAD-Studie (MCL 2005-01)

20.09.2011 R-HAD-Studie (MCL 2005-01)
Designrandomisiert, multizentrische Phase III-Studie
HauptendpunkteTime to treatment failure
NebenendpunkteComplete and overall response rate, progression-free survival, duration
of remission, time to next lymphoma treatment, overall survival, safety
and tolerability of Rituximab, high-dose Ara-C and dexamethasone alone
or in combination with Bortezomib
StudienpopulationMCL-Relapse or progression following 1 to 3 prior lines of anti-neoplastic
standard therapy.
TherapieTreatment course will be repeated in 3-week intervals (day 22):
Rituximab, 375 mg/m² IV, d1
Ara-C 2000 mg/m² (patients >65 years or s/p myeloablative treatment:
1000 mg/m²) IV, d 2 and 3
Dexamethasone 40 mg PO d 1- 4
+ Bortezomib 1.5 mg/m² IV, d 1 and 4
After 2 treatment cycles a midterm staging will be performed.
Responders to induction therapy will receive 2 additional treatment cycles
in case of adequate tolerability.
Erforderliche Patientenzahl175-275
Zeitplan3,5 Jahre (maximal 5,5 Jahre)
Protokollversion2,0
StudienleitungCoordinating investigator, Germany:
Prof. Dr. M. Dreyling
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
Coordinating investigator, France:
Dr. V. Ribrag
Institut Gustave Roussy
Dept. of Medicine
39 rue C Desmoulins
94805 Villejuif / FRANCE
Phone: +33-1-42-11-43-21
Fax: +33-1-42-11-43-47
e-mail: ribrag@igr.fr
Since
SponsorKlinikum der Ludwig- Maximilians-Universität München
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