Beschreibung

Rekrutierung gestartet

Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

Studientherapie

Patients with PET positive remaining lymphoma after diagnostic surgery will be randomized in one of two arms using the strata stage (I / II) and remaining lymphoma <11mm (yes/no) (see also figure below):


Arm 1 (Standard arm): 8x Rituximab (375mg/m2) in weeks 1,2,3,4,9,10,11,12. Radiation therapy of the involved sites 12 x 2 Gy (week 9-11)
Arm 2 (Experimental Arm): 7x Obinutuzumab (1000mg) in weeks 1,2,3,4,8,12,16. Radiation therapy of the involved sites 2 x 2 Gy (week 9)
All patients receive restating FDG-PET for response evaluation in week 18. Patients of the experimental arm, who don't show a metabolic CR will receive a salvage RT as in the GAZAI study.


Patients, who do not show remaining PET positive lymphoma after diagnostic surgery (about 25-30% according to GAZAI study) should receive the treatment of the experimental arm without restaging FDG-PET/CT in week 18 and should be evaluated for secondary endpoints.

• trial chart
   
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