Trial Information
An Open-label Study of the Effect of the Addition of MabThera to Standard Chemotherapy on Clinical Response in Patients With Previously Untreated Mantle Cell Lymphoma
Inclusion Criteria:
- histologically-proven mantle cell lymphoma;
- previously untreated disease at stage II, III and IV, requiring therapy.
Exclusion Criteria:
- known hypersensitivity reaction to rituximab, or known anti-murine antibody
reactivity or known hypersensitivity to murine antibodies;
- active malignancy other than mantle cell lymphoma within 5 years of start of study,
with the exception of resected basal cell cancer, squamous cell cancer of the skin,
or in situ cancer of the cervix;
- serious disorders interfering with full standard dosing chemotherapy;
- stage I disease.
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:
Complete and partial response
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Hungary: Ministry of Health
Study ID:
ML20493
NCT ID:
NCT00472420
Start Date:
June 2007
Completion Date:
March 2014
Related Keywords:
- Mantle Cell Lymphoma
- Lymphoma
- Lymphoma, Mantle-Cell