A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a
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Lead
Hoffmann-La Roche
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult participants , \>/= 18 and \</= 80 years of age
Histologically confirmed, previously untreated CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2, or 3a, according to World Health Organization (WHO) classification
An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion \>/= 7.5 cm, or Follicular Lymphoma International Prognostic Index (FLIPI; low, intermediate or high risk)
At least one bi-dimensionally measurable lesion defined as \>/=1.5 cm in its largest dimension on CT scan
Eastern Cooperative Oncology Group (ECOG) performance status \</= 3
You may not be if
Transformed lymphoma or follicular lymphoma IIIB
Primary central nervous system (CNS) lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
History of other malignancy that could affect compliance with the protocol or interpretation of the results; this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission for \>/= 5 years prior to enrolment; participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible
Prior therapy for DLBCL or NHL, with the exception of nodal biopsy or local irradiation
Prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate for CNS prophylaxis in DLBCL) or rituximab for another condition, or prior use of an anti-CD20 drug
Prior use of monoclonal antibody within 3 months prior to randomization
Chemotherapy or other investigational therapy within 28 days prior to randomization
Ongoing corticosteroid use \> 30 mg/day prednisolone or equivalent
Inadequate renal. hematologic or hepatic function
Active and/or severe infection or any major episode of infection within 4 weeks prior to randomization
Active hepatitis B virus or active hepatitis C virus infection
History of human immunodeficiency (HIV) seropositive status
A positive pregnancy test in women of childbearing potential
Life expectancy of less than 6 months
Clareo Health | A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a
