Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma
Conditions
Non-Hodgkin's Lymphoma
Conditions: official terms
Lymphoma, Non-Hodgkin
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CHOEP + Rituximab Type: Drug
Name: Mega-CHOEP + Rituximab Type: Drug
Overall Status
Recruiting
Summary
Comparison of aggressive conventional therapy with repetitive high-dose therapy plus rituximab. Hypothesis: better overall survival and/or progression-free survival in HDT+R.
Detailed Description
This study compares aggressive conventional therapy (8 courses of rituximab plus CHOEP given every 2 weeks) with repetitive high-dose therapy (Mega-CHOEP) supplemented with rituximab. The study question is whether overall survival or progression-free survival is better with high-dose therapy than with conventional treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 18-60 years of age

- Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted)

- Performance status: ECOG 0-3

- Patient's written informed consent

- Aggressive non-Hodgkin's lymphoma

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
Location
AK St. Georg
Hamburg, Germany
Status: Recruiting
Contact: Norbert Schmitz, Prof. - +49 40 181885 - norbert.schmitz@ak-stgeorg.lbk-hh.de
Start Date
March 2003
Completion Date
March 2011
Sponsors
German High-Grade Non-Hodgkin's Lymphoma Study Group
Source
German High-Grade Non-Hodgkin's Lymphoma Study Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page