A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 plus CVP vs. MabThera® plus Cyclophosphamide,
Vincristine, Prednisone vs. MabThera® plus Cyclophosphamide, Vincristine, Prednisone, followed by GP2013 or MabThera® Maintenance Therapy in Patients with Previously Untreated, Advanced Stage Follicular Lymphoma

1. Patient with previously untreated advanced stage, CD20-positive FL:
a. Ann Arbor classification stage III/IV;
b. WHO histologic grade 1, 2 or 3a, as confirmed by central pathological testing; and
c. Require therapy for FL as per local guidelines or in the opinion of the treating physician.
2. Patient age * 18 years.
3. Patient with at least one measurable lesion (accurately measureable in at least 2 perpendicular dimensions);
a. at least 1 measurable nodal lesion > 20 mm in the long axis; OR
b. at least 1 measurable extranodal lesion with both long and short axes * 10 mm.
4. Patient with ECOG performance status 0, 1 or 2.
5. Patient with adequate cardiac function defined as cardiac ejection fraction * 45% as measured by 2D-ECHO or MUGA, without clinically significant abnormalities.
6. Patient with the following laboratory values obtained during Screening (up to 28 days before randomization):
a. hemoglobin * 10g/dL (unless abnormalities are due to histologically proven bone marrow involvement by lymphoma);
b. absolute neutrophil count (ANC) * 1.5 x 109/L (unless abnormalities are due to histologically proven bone marrow involvement by lymphoma);
c. platelet count * 100 x 109/L (unless abnormalities are due to histologically proven bone marrow involvement by lymphoma);
d. total bilirubin < 1.5 x ULN (upper limit of normal) (if Gilbert-Meulengracht syndrome is present, up to 2.0 x ULN is allowed);
e. transaminases < 2.5 x ULN;
f. serum creatinine level < 2 x ULN or calculated creatinine clearance > 50 mL/min;
g. negative serologic or virologic markers for active of latent hepatitis B and hepatitis C infections.

1. Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a.
2. Patient with histological evidence of transformation to high grade or diffuse large B-cell lymphoma.
3. Patient who has previously received any prior therapy for lymphoma, e.g. cytostatic or cytotoxic agents, antibodies, anti-lymphoma vaccination, experimental treatments and radiotherapy, except who received involved field radiation 4 weeks prior to Cycle 1 Day 1, of up to
two lesions that will not be used to evaluate disease progression.
4. Evidence of significant leukemic disease defined as >10 x 109 /L circulating CD20+ lymphoma cells.
5. Patient with clinical evidence of central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord compression by lymphoma.
6. Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial, including tuberculosis, or fungal).
7. Patient receiving chronic (>3 months), high dose (> 20 mg of prednisone or > approximately 3 mg of dexamethasone per day or equivalent doses of other steroid medications) of systemic corticosteroids.
8. Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
9. Patient with a known hypersensitivity to any of the study treatment ingredients e.g. to recombinant human antibodies.
10. Patient with concurrent serious illnesses, uncontrolled medical conditions, or other medical history including clinically relevant abnormal laboratory results, which in the investigator*s opinion would be likely to interfere with a patient*s participation in the study, or with the interpretation of study results:
a. uncontrolled neurological disease (e.g. recurrent seizures despite existing anticonvulsant therapy);
b. neuropathy * grade 1, neuromuscular disease;
c. severe disturbance of liver function;
d. severe constipation;
e. cystitis or other ongoing infections;
f. disturbance of micturition;
g. severe chronic obstructive pulmonary disease with clinically manifest hypoxemia (dyspnea > grade 1);
h. uncontrolled hypertension (defined as systolic BP > 160 mm Hg or diastolic > 100 mm Hg);
i. history of stroke or cerebral ischemia (within 6 months prior to randomization);
j. history of myocardial infarction or other clinically significant myocardial disease (within 6 months prior to screening) or unstable angina (* NYHA Grade II);
k. inadequate cardiac function defined as cardiac ejection fraction < 45% as measured by 2D-ECHO or MUGA;
l. known infection with HIV or any other severe immune-compromised state according to patient history (if required by local regulations or clinical practice guidelines, patient may be tested during the screening period to confirm HIV status);
m. evidence of ongoing drug or alcohol abuse within the last 6 months before screening;
n. Active tuberculosis. Patients with evidence of latent tuberculosis as per results of the tuberculosis screening test and further follow-up may enter the study after evaluation by an appropriate specialist and after sufficient treatment has been initiated according to local medical practice.
11. Patient has had major surgery, open biopsy or trauma within 4 weeks prior to date of screening (lymph node biopsy is not regarded as major surgery), or expects the need for major surgery during the course of study treatment.
12. Patient plans to receive live vaccines during the study or has received live vaccines 4 weeks prior to date of screening. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines.
13. Patient is using growth factors or transfusions to meet study eligibility requirements during Screening period. (The use of growth factors and transfusions during screening is permissible, if there is suspicion of bone marrow involvement by lymphoma and patient is deemed not to be growth factor-dependent or transfusion-dependent)