Trial Information
A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
- patients who have received adequate (>=8 cycles) induction therapy with MabThera as
first line treatment, or treatment for relapsed disease;
- demonstrated partial or complete response to induction therapy.
Exclusion Criteria:
- stable or progressive disease after most recent induction therapy;
- transformation to high grade lymphoma;
- patients with prior or concomitant malignancies, except non-melanoma skin cancer or
adequately treated in situ cancer of the cervix.
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:
Incidence of all, and of grade 3/4, adverse events.
Outcome Time Frame:
Throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
MO19872
NCT ID:
NCT00430352
Start Date:
September 2006
Completion Date:
September 2012
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin