Status:
COMPLETED
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Diffuse Large B-Cell Lymphoma (DLBCL)
Follicular NHL Grade 3b
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful...
Eligibility Criteria
Inclusion
- 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
- Transformed lymphoma
- Secondary malignancy
- Evidence of CNS - involvement
- Significant cardiac disease
- Creatinine \> 2.0 mg/dl
- HIV, Hepatitis positive
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
683 Patients enrolled
Trial Details
Trial ID
NCT00400478
Start Date
January 1 2006
End Date
March 1 2013
Last Update
May 26 2016
Active Locations (131)
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1
Border Medical Oncology
Wodonga, Victoria, Australia
2
Concord Repatriation General Hospital
Concord, Australia
3
Gosford Hospital
Gosford, Australia
4
Greenslopes Hospital
Greenslopes, Australia