A Multicentre, Phase III, Open Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) + Chemotherapy Compared to Rituximab + Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic,
nodal or extranodal marginal zone lymphoma)
- Stage III or IV disease, or Stage II bulky disease (defined as tumour diameter >/= 7
cm), requiring treatment
- For patients with follicular lymphoma: requirement for treatment according to GELF
criteria
- For patients with symptomatic marginal zone lymphoma: disease that is de novo or has
relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy
as assessed by the investigator
- At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT
scan or MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Adequate hematologic function
Exclusion Criteria:
- Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of
transformation to a high-grade or diffuse large B-cell lymphoma
- Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's
macroglobulinaemia
- Ann Arbor Stage I disease
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy,
known hypersensitivity to any of the study drugs or sensitivity to murine products,
or history of sensitivity to mannitol
- For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma
with chemotherapy, immunotherapy, or radiotherapy
- For patients with non-follicular lymphoma: prior treatment with chemotherapy or
immunotherapy
- Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle
1
- Evidence of significant, uncontrolled concomitant diseases that could affect
compliance with the protocol or interpretation of results
- For patients who will be receiving CHOP: LVEF <50% by MUGA scan or echocardiogram
- History of prior malignancy with the exception of curatively treated basal or
squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
- Known active infection, or major episode of infection within 4 week prior to the
start of Cycle 1
- Vaccination with a live vaccine within 28 days prior to randomization
- Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for
diagnosis
- Abnormal laboratory values as defined by protocol for creatinine, creatinine
clearance, AST or ALT, total bilirubin, INR, PTT or aPPT, unless these abnormalities
are due to underlying lymphoma
- Positive as per protocol definition for HIV, HTLV1, hepatitis C or chronic hepatitis
B
- Pregnant or lactating women
- Life expectancy < 12 months
- Participation in another clinical trial with drug intervention within 28 days prior
to start of Cycle 1 and during study