PETReA: This phase III trial will assign patients with follicular lymphoma to a certain type of treatment using a PET-scan and assess overall outcomes associated with treatmentPhase 3 evaluation of PET-guided, Response-Adapted therapy in patients with previously untreated, high tumour burden follicular lymphoma

Inclusion

1. Must be greater than or equal to 18 years of age at the time of signing the informed consent form.
2. Must be able to adhere to the study visit schedule and other protocol requirements.
3. Must have a documented diagnosis of follicular lymphoma (grade 1, 2 or 3a).
4. Must be at non-contiguous stage II, stage III or stage IV.
5. Must fulfil at least one of the Groupe d'Etude des Lymphomas Folliculaires (GELF) GELF criteria for high tumour burden:
a. Systemic symptoms (> 10% weight loss, temperature greater than or equal to 38°C for more than 5 days, abundant night sweats)
b. Performance status (PS) greater than 1 according to the Eastern Cooperative Oncology Group (ECOG) scale
c. Elevated lactate dehydrogenase (LDH) level
d. ß2-microglobulin level greater than 25.5 nM/L (3 µg/mL)
e. A single lymph node larger than 7 cm
f. Involvement of at least 3 nodal sites, each with diameter greater than 3 cm
g. Marked splenomegaly
h. Organ failure
i. Pleural effusion or ascites
j. Orbital or epidural involvement
k. Blood infiltration
l. Cytopenia
6. Must not have received prior systemic therapy (local radiotherapy is permitted).
7. Must have a WHO performance status score of less than or equal to 2.
8. Must agree to adhere to the Celgene guidance on pregnancy prevention.