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.
- 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.
- 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:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of all, and of grade 3/4, adverse events.
Outcome Time Frame:
Italy: Ministry of Health
- Non-Hodgkin's Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin