A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients, \>/= 18 and \</= 80 years of age at time of study inclusion
Histologically confirmed, previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) according to the WHO classification system
Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with bulky disease, defined as one lesion \>/= 7.5 cm
At least one bi-dimensionally measurable lesion defined as \>/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI
Adequate hematologic function
Eastern Cooperative Oncology Group (EOCD) performance status \</= 2
You may not be if
Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
Transformed lymphoma or follicular lymphoma IIIB
Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for \>/= 5 years prior to enrolment
Inadequate renal or hepatic function
Known human immunodeficiency virus (HIV) infection or HIV seropositive status
Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
Pregnant or lactating women
Clareo Health | A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
