This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
375 mg/m2 intravenously once a week for 4 weeks
Unnamed facility
Toulouse, France
Treatment response rate according to World Health Organization criteria (Group A)
Time frame: Day 50
Normalization of B-cell lymphoma 2 levels
Time frame: Day 50
Safety: Incidence of adverse events
Time frame: 3 years
Progression-free survival
Time frame: 3 years
Duration of treatment response
Time frame: 3 years
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