Status:
COMPLETED
A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-c...
Eligibility Criteria
Inclusion
- histologically-proven mantle cell lymphoma;
- previously untreated disease at stage II, III and IV, requiring therapy.
Exclusion
- 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.
Key Trial Info
Start Date :
June 27 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00472420
Start Date
June 27 2007
End Date
May 25 2011
Last Update
August 15 2017
Active Locations (7)
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1
National Institute of Oncology, A Dept of Internal Medicine
Budapest, Hungary, 1122
2
University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
Debrecen, Hungary, 4032
3
Petz Aladar Megyei Korhaz; Hematologia
Győr, Hungary, 9024
4
Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
Kaposvár, Hungary, 7400