20
Participants
Start Date
October 31, 2006
Primary Completion Date
December 31, 2012
Study Completion Date
May 31, 2013
ibritumomab tiuxetan
185 MBq (5mCi) of 111In-Zevalin will be used for radioimaging. and the dose is 14.8 MBq/kg (0.4 mCi/kg) total body weight of 90Y-Zevalin (max. 1184 MBq or 32 mCi at patients \> 80kg) for imaging.
rituximab
250 mg/m2
melphalan
"* Dose level 1: 100 mg/m2~* Dose level 2: 140 mg/m2~* Dose level 3: 170 mg/m2~* Dose level 4: 200 mg/m2"
vinorelbine tartrate / G-CSF
on day 1: 35 mg/m2 day 4-8 (longer if required) G-CSF 5 μg/kg s.c. morning and 5 μg/kg s.c. evening for at least 5 days
autologous hematopoietic stem cell harvesting and transplantation
"Optimal mobilization usually takes place on day 8. A minimum of 2.5x106 CD34+ cells/kg should be collected (optimal 5x106 CD34+ cells/kg). If not enough CD34+ cells can be collected on day 8, it is recommended to continue with G-CSF until a sufficient collection (a minimum of 2.5x106 CD34+ cells/kg) can be obtained.~Stem cells will be reinfused approximately 24 hours after the melphalan administration. The infusion will be performed with a minimum of 2.5x106 CD34+ cells/kg body weight according to local guidelines. G-CSF (5 μg/kg/d) will be given from day 5 and continued until neutrophils \> 0.5x109/l for at least 2 consecutive days."
Inselspital Bern, Bern
Saint Claraspital AG, Basel
Kantonsspital Bruderholz, Bruderholz
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli, Bellinzona
Kantonsspital Aarau, Aarau
Universitaetsspital-Basel, Basel
Kantonsspital Liestal, Bern
Hopital Cantonal Universitaire de Geneve, Geneva
Centre Hospitalier Universitaire Vaudois, Lausanne
Kantonsspital - St. Gallen, Sankt Gallen
Swiss Cancer Institute
OTHER