Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma

• Status: Unknown status
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better time to treatment failure (TTTF)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group
• Collaborator: Deutsche Krebshilfe e.V., Bonn (Germany)
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Other concomitant tumour disease