A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma
- Registration Number
- NCT01388959
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Adult patients, 18-75 years of age
- Diagnosis of follicular non-Hodgkin's lymphoma (FNHL)
- Previously treated with chemotherapy with autologous haemotopoietic stem cell transplantation (bone marrow or peripheral blood cells)
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Exclusion Criteria
- Active viral hepatitis
- Eastern Cooperative Oncology Group (ECOG) performance status >2
- Patients not willing to sign informed consent form
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm rituximab [MabThera/Rituxan] -
- Primary Outcome Measures
Name Time Method Normalization of B-cell lymphoma 2 levels Day 50 Treatment response rate according to World Health Organization criteria (Group A) Day 50
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events 3 years Progression-free survival 3 years Duration of treatment response 3 years