NCT05929222

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

An Open-label, Randomized Phase III Trial Comparing Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage (I-II non-bulky). Patients will be randomized to receive: \- Involved-Site Radiation Therapy at standard dose 24Gy - standard arm OR \- Involved-Site Radiation Therapy at standard dose 24Gy followed by Obinutuzumab 4 infusions weekly + 4 infusions every 3 weeks (8 total doses) - experimental arm

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Involved-Site Radiation Therapy 24Gy
OTHER	Radiotherapy plus Obinutuzumab	Involved-Site Radiation Therapy 24Gy followed by Obinutuzumab 1000mg flat dose 4 doses weekly plus addition 4 doses every 3 weeks

Timeline

• Start date: 2023-12-14
• Primary completion: 2031-04-01
• Completion: 2031-04-01
• First posted: 2023-07-03
• Last updated: 2025-12-24

Locations

48 sites across 1 country: Italy