Melphalan, Yttrium Y 90 Ibritumomab Tiuxetan, and Rituximab Followed by Autologous Stem Cell Transplant in Treating Older Patients With Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

December 31, 2012

Study Completion Date

May 31, 2013

Conditions
Lymphoma
Interventions
DRUG

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.

DRUG

rituximab

250 mg/m2

DRUG

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"

DRUG

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

PROCEDURE

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."

Trial Locations (10)

3010

Inselspital Bern, Bern

4016

Saint Claraspital AG, Basel

4101

Kantonsspital Bruderholz, Bruderholz

6500

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli, Bellinzona

CH-5001

Kantonsspital Aarau, Aarau

CH-4031

Universitaetsspital-Basel, Basel

CH-3008

Kantonsspital Liestal, Bern

CH-1211

Hopital Cantonal Universitaire de Geneve, Geneva

CH-1011

Centre Hospitalier Universitaire Vaudois, Lausanne

CH-9007

Kantonsspital - St. Gallen, Sankt Gallen

All Listed Sponsors
lead

Swiss Cancer Institute

OTHER

NCT00392691 - Melphalan, Yttrium Y 90 Ibritumomab Tiuxetan, and Rituximab Followed by Autologous Stem Cell Transplant in Treating Older Patients With Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment | Biotech Hunter | Biotech Hunter