Status:
TERMINATED
A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autol...
Eligibility Criteria
Inclusion
- adult participants, \>/=18 years of age
- untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
- known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- adequate hematological, renal and hepatic function
Exclusion
- known hypersensitivity to murine proteins or chemotherapy regimen
- previous first-line therapy
- history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
- active infection
- clinically significant cardiac disease
- regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01144403
Start Date
June 1 2010
End Date
August 1 2014
Last Update
October 18 2016
Active Locations (8)
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1
Brasov, Romania, 500326
2
Bucharest, Romania, 005098
3
Bucharest, Romania, 022328
4
Bucharest, Romania, 030171