Status:
COMPLETED
A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
60-75 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further ther...
Eligibility Criteria
Inclusion
- adult patients 60-75 years of age;
- B-cell follicular NHL;
- no previous treatment;
- active disease, with rapid progression.
Exclusion
- other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
- long-term use (\>1 month) of systemic corticosteroids;
- central nervous system involvement;
- history of significant cardiovascular disease;
- positive test result for HIV, or hepatitis B or C.
Key Trial Info
Start Date :
January 19 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2011
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT01144364
Start Date
January 19 2004
End Date
July 21 2011
Last Update
August 15 2017
Active Locations (45)
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1
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
Pescara, Abruzzo, Italy, 65100
2
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, Italy, 70124
3
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
San Giovanni Rotondo, Apulia, Italy, 71013
4
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, Italy, 89100