About this trial
Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinutuzumab.
Eligibility criteria
Qualifiers
Histological documented diagnosis of Follicular Lymphoma grade I-IIIA as defined in the 2017 edition of World Health Organization (WHO)
Ann Arbor Stage IA or IIA (includible in one radiation field), or IE, non-bulky (<7 cm). Stage must be determined by PET/CT scan (Appendix 2)
Patients performing PET before surgery can also be enrolled without repeating PET after surgery
No previous treatment except for steroid pre-treatment
Disqualifiers
Histological diagnosis of Follicular lymphoma grade IIIb
Staging >II or B symptoms or bulky disease (> 7 cm)
Stage II with distant involved sites, not includible in a single radiation field
Primary cutaneous follicular lymphoma
Trial design
Treatments tested in this trial
- Radiotherapy
- Radiotherapy plus Obinutuzumab