500
Participants
Start Date
January 31, 2000
Study Completion Date
February 28, 2005
Alternating chemotherapy
"4 cycles of alternating chemotherapy VBMCP/VBAD (every 5 weeks). VBMCP: Vcr 2 mg ev day 1, BCNU 0.5 mg/kg ev day 1, Cyclophosphamide 10 mg/kg day 1, Melphalan 0.25 mg/kg v.o. days 1-4, Prednisone 1 mg/kg v.o. days 1-4, 0.5 mg/kg days 5-8 and 0.25 mg/kg days 9-12.~VBAD: Vcr 1 mg e.v. day 1, BCNU 30 mg/m 2 e.v. day 1, Adriamycine 40 mg/m 2 day 1, Dexamethasone 40 mg/m 2 days 1-4, 9-12 and 17-20."
Autologous Transplantation
"Autologous Transplantation :~BUMEL:Busulfan, total dose 12 mg/kg (days -6 a -3; prophylaxis with difenilhidantoine) Melphalan 140 mg/m 2 , ev day -2 TASPE: To investigator criteria"
Maintenance
"At 3 months of transplantation or with \>1.500 neutrophiles/ \> 75.000 platelets mm 3 .~Prednisone: 50 mg alternating days during 2 years Interferon alfa 2-b: 3 M UI s.c. Three times a week until relapse."
Second transplantation
In cases that no reach CR with BUMEL is programmed second transplantation, after 4-8 months .
ALOGENIC MINI TRASPLANTATION
ALOGENIC MINI TRASPLANTATION Fludarabine 30 mg / m 2 / day, days -7, -6, -5, -4, -3 Melphalan 70 mg / m 2 / day, day -2 Prophylaxis EICH: CsA + MTX or CsA + MOFETIL
PETHEMA Foundation
OTHER