106
Participants
Start Date
May 31, 2002
Study Completion Date
October 31, 2006
immunotherapy
"Given together with induction chemotherapy:~Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses"
Induction treatment part 1
"cyclophosphamide 3000 mg/m2 iv every 3 weeks, 3 cycles vincristin 2 mg iv every 3 weeks, 3 cycles doxorubicin 75 mg/m2 iv every 3 weeks, 3 cycles Prednisolone 300 mg/m2 divided into five days po every 3 weeks, 3 cycles pegfilgrastim 6 mg sc every 3 weeks.~3 cycles consisting of combination treatment of above mentioned drugs are given."
Induction treatment part 2 with PBPC collection
"Starts three weeks after last cycle of Induction part 1.~Etoposide 240 mg/m2 divided into equal doses for four days, together with methylprednisolone 2000 mg divided into equal doses for four days, together with cisplatin 100 mg/m2 divided into equal doses for four days, and together with cytarabine 2000 mg/m2 iv one dose on 4th day of treatment. Filgrastim 10-12 ug/kg from day five after start of chemotherapy untill stem cell collection.~Peripheral blood progenitor cell collection (PBPC) is started when CD34 positive cells are \>20/cubic milimeter of blood and continued untill 5 million of CD34 positive cells are collected from peripheral blood."
Induction treatment part 3
"Part 3 of induction treatment is given approximately one week after the end of Part 2.~Etoposide 240 mg/m2 divided into equal doses for four days, methylprednisolone 2000 mg divided into equal doses for four days, cisplatin 100 mg/m2 divided into equal doses for four days, cytarabine 2000 mg/m2 iv one dose on day 4 of chemotherapy and pegfilgrastim 6 mg on day five of chemotherapy are given twice three weeks apart."
Consolidation treatment part 1: HD-chemotherapy with ASCT
"Consolidation treatment Part 1 starts 4-8 weeks after the second cycle of Induction treatment Part 3.~High dose chemotherapy (HD-chemotherapy) consists of:~BCNU 300 mg/m2 is given on day 1, etoposide 800 mg/m2 divided into four equal doses is given on day 2-5, cytarabine 1600 mg/m2 divided into eight equal doses is given on day 2-5, melphalan 140 mg/m2 is given on day 6.~On day 7, collected stem cells from peripheral blood (see Induction treatment part 1) are infused back to the patient. This is called autologous transplantation (ASCT). Filgrastim 5 ug/kg is given from day 14 (start of the chemotherapy being day 1) until neutrophil recovery."
Consolidation treatment part 2: Radiotherapy
Radiotherapy is started given 4-8 weeks after the autologous transplantation. It is given to patients with initially bulky disease (\>10 cm at diagnosis) or to patients with residual disease after Induction treatment part 1-3 and Consolidation treatment part 1. 30-40 Gy are given in 2 Gy fractions over 3-4 weeks.
University Hospital Brno-Bohunice, Brno
Hospital Chomutov, Chomutov
Hospital České Budějovice, České Budějovice
University Hospital Hradec Králové, Hradec Králové
University Hospital Královské Vinohrady, Prague
General University Hospital, Prague
University Hospital Motol, Prague
Hospital Ústí nad Labem, Ústí nad Labem
Ministry of Health, Czech Republic
OTHER_GOV
Hoffmann-La Roche
INDUSTRY
Czech Lymphoma Study Group
OTHER