Status:
COMPLETED
Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma
Lead Sponsor:
German High-Grade Non-Hodgkin's Lymphoma Study Group
Collaborating Sponsors:
Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions:
Non-Hodgkin's Lymphoma (NHL)
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 (...
Detailed Description
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00129090
Start Date
March 1 2003
End Date
October 1 2017
Last Update
May 25 2023
Active Locations (1)
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1
AK St. Georg
Hamburg, Germany, 20099