A Single Arm, Multicentre, Phase IIIb Study to Evaluate Safety, Efficacy and Pharmacokinetic (PK) of Subcutaneous (SC) Rituximab Administered During Induction Phase or Maintenance in Previously Untreated Patients With CD20+ Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)
Inclusion Criteria:
- Adult patients, age > or = 18 and < or = 80 years at time of enrolment
- Histologically confirmed, CD20+ DLBCL or CD20+ follicular NHL grade 1, 2 or 3a,
according to the WHO classification system
- Currently being treated with MabThera/Rituxan intravenously (IV) in the Induction or
Maintenance setting, having received at least one full dose of MabThera/Rituxan IV,
defined as standard full dose of MabThera/Rituxan IV 375 mg/m2 administered without
interruption or early discontinuation because of tolerability issues
- Expectation and current ability for the patient to receive at least four additional
cycles of treatment during the Induction phase or six additional cycles of treatment
during the Maintenance phase (patients with follicular NHL)
- Induction only: An International Prognostic Index (IPI) score of 1-4 or IPI score of
0 with bulky disease, defined as one lesion > or = 7.5 cm, or Follicular Lymphoma
International Prognostic Index (FLIPI)
- Induction only: At least one bi-dimensionally measurable lesion defined as > or = 1.5
cm in its largest dimension on computed tomography (CT) scan
- Eastern Cooperative Oncology Group (ECOG) performance status < or = 3
Exclusion Criteria:
- Transformed lymphoma or follicular lymphoma (FL) IIIB
- Primary central nervous system lymphoma, histologic evidence of transformation to a
Burkitt lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the
testis, or primary cutaneous DLBCL
- History of other malignancy
- Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent.
- Inadequate renal and hematologic or hepatic function
- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies or known sensitivity or allergy to murine products
- For patients with DLBCL - Contraindication to any of the individual components of
CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior
receipt of anthracyclines
- Other serious underlying medical conditions, which, in the Investigator's judgment,
could impair the ability of the patient to participate in the Study
- Recent major surgery (within 4 weeks prior to dosing, other than for diagnosis)
- Active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or human
immunodeficiency virus (HIV) infection