A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, B-Cell
Both
Lymphoma, B-Cell
Trial Information
A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma
Inclusion Criteria:
- adult patients, >/=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
- ECOG performance status 0-2
- adequate hematological, renal and hepatic function
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate (ORR), according to International Working Group (IWG) criteria, assessed by computed tomography (CT) or magnetic resonance imaging (MRI)
Outcome Time Frame:
approximately 2.5 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Romania: National Medicines Agency
Study ID:
ML22489
NCT ID:
NCT01144403
Start Date:
June 2010
Completion Date:
December 2013
Related Keywords:
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Mantle-Cell
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