Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
German High-Grade Non-Hodgkin's Lymphoma Study Group
With
Deutsche Krebshilfe e.V., Bonn (Germany)
This study was primarily designed to compare aggressive conventional chemotherapy with a repetitive high-dose (HD) therapy program using identical, effective drugs at highest possible dose and dose intensity with/without addition of rituximab (initially 4 treatment arms). In 2004 the first amendment had to be added in order to close two treatment arms without rituximab due to recent data revealing a significant advantage for rituximab-treated patients with CD20+lymphoma.
A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage. The last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems.
As the high-dose arm was closed only CD20+ B-lymphoma were included past amendment 2.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18-60 years of age
Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted)
Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3
Patient's written informed consent
Aggressive non-Hodgkin's lymphoma with CD20+ histology
You may not be if
Already initiated lymphoma therapy
Serious accompanying disorder or impaired organ function
Bone marrow involvement \> 25%
Known hypersensibility to the medications to be used
Known HIV-positivity
Active hepatitis infection
Suspicion that patient compliance will be poor
Simultaneous participation in other trials
Prior chemo- or radiotherapy for previous disorder
