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

ConditionFollicular Lymphoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy

    Radiation

    Involved-Site Radiation Therapy 24Gy

  • Radiotherapy plus Obinutuzumab

    Other intervention

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

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Standard ArmActive comparator 1 intervention
Group B: Experimental ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Time between the randomization to first documentation of recurrence, progression or death from any cause at 2 years

Time frame
From treatment start up to 33 months (9 months treatment period and 24 months of follow-up)

Secondary outcomes

1

Complete response rate (CRR)

Complete response (CR) rate according to the international criteria (Cheson 2014)

Time frame
From therapy start up to end of treatment (9 months)
2

Overall response rate (ORR)

ORR will be defined as the proportion of patients who have a partial or complete response at every treatment phase

Time frame
From therapy start up to end of treatment (9 months)
3

Disease Free Survival (DFS)

Time between the first documentation of Complete Response to any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of a new treatment without documented progression) or death from any cause

Time frame
From post radiotherapy assessment up to 45 months (9 months treatment phase plus 36 months of follow-up)
4

Event Free Survival (EFS)

Time between the randomization to any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of a new treatment without documented progression) or death from any cause

Time frame
From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Italiana Linfomi - ETS

Lead sponsor

Source ClinicalTrials.gov
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