Status:
COMPLETED
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Lymphocytic Leukemia, Chronic
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previou...
Eligibility Criteria
Inclusion
- adult patients, \>=60 years of age;
- CD20+ chronic lymphocytic leukemia (CLL);
- no previous treatment for CLL;
- ECOG performance status 0-1.
Exclusion
- co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
- history of severe cardiac disease;
- transformation to aggressive B-cell malignancy.
Key Trial Info
Start Date :
November 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2013
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00738374
Start Date
November 3 2008
End Date
January 14 2013
Last Update
August 15 2017
Active Locations (20)
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1
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, Italy, 70124
2
Az. Osp. Pugliese; Dh Oncologico
Catanzaro, Calabria, Italy, 88100
3
P.O. Annunziata; U.O. Ematologia
Cosenza, Calabria, Italy, 87100
4
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, Italy, 89100