OncoMatch/Clinical Trials/NCT05929222

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

Is NCT05929222 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for follicular lymphoma.

Phase 3RecruitingFondazione Italiana Linfomi - ETSNCT05929222Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: BCL2 BCL2/IGH positive cells by PCR

Qualitative/quantitative PCR centralized assessment of BCL2/IGH positive cells in peripheral blood (PB), bone marrow (BM).

Required: BCL2 t(14;18) by FISH

Centralized revision of the lymph node biopsy with FISH for t(14;18)

Disease stage

Required: Stage IA, IIA, IE (Ann Arbor)

Excluded: Stage IIB, III, IV

Grade: IIIIIIA (WHO 2017)

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

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Lab requirements

Kidney function

creatinine clearance ≥ 40 ml/min (cockcroft-gault formula)

Liver function

ast and alt ≤ 3.0 x unl; bilirubin ≤1.5 x unl (unless due to gilbert's syndrome or non-hepatic origin)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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