Trial Information
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-Cell Lymphoma: NHL-13
Inclusion Criteria:
- 4 to 8 cycles R-CHOP/like, total of 8x Rituximab
- CR, CRu
- ECOG/ 0.1 or 2
- Known IPI at time of diagnosis
- Age > 18 years
- Negative pregnancy test
- Men must agree not to father a child during the therapy
Exclusion Criteria:
- Transformed lymphoma
- Secondary malignancy
- Evidence of CNS - involvement
- Significant cardiac disease
- Creatinine > 2.0 mg/dl
- HIV, Hepatitis positive
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
event free survival
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Ulrich Jaeger, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of Vienna
Authority:
Austria: Ethikkommission
Study ID:
NHL-13 (ML18223)
NCT ID:
NCT00400478
Start Date:
January 2006
Completion Date:
December 2012
Related Keywords:
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Follicular NHL Grade 3b
- DLBCL
- NHL 13
- Rituximab
- maintenance
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse