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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT05929222
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 3, 2023
Start date
Dec 14, 2023
Status verified
May 2026
Primary completion
Apr 30, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Arm
    Radiotherapy alone
  • Experimental: Experimental Arm
    Radiotherapy plus Obinutuzumab

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From treatment start up to 33 months (9 months treatment period and 24 months of follow-up) ]

Central Contacts

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