Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS

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

Treatment groups

190 Participants
are divided into 2 treatment groups