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Multicenter, single arm, phase-2 study for combination of Obinutuzumab and Lenalidomide for relapsed or refractory follicular B-cell Lymphoma (GALEN)


08th July 2019

The combination of Lenalidomide and Rituximab is successful and administered to treat patients with relapsed or refractory follicular lymphoma. Obinutuzumab has demonstrated to increase antibody-dependent cellular cytotoxicity, phagocytosis, and B-cell direct killing better than rituximab. The objective of the study was to determine the activity and safety of lenalidomide plus obinutuzumab in previously treated patients with relapsed or refractory follicular lymphoma.

24 centres for Lymphoma Academic Research Organization in France were used for enrolling the subjects. Eligibility as per the inclusion criteria for the subject includes age should be 18 years or above; subject should have histologically confirmed CD-20 positive relapsed or refractory follicular lymphoma of WHO grade 1, 2 or 3a; an ECOG performance status of 0–2; and went through at least one previous rituximab-containing therapy.

The primary endpoint of the study was the proportion of subjects who attained an overall response at induction end as per assessment of investigator. The secondary endpoints were adverse event free survival, progression-free survival, overall survival, and safety. As per the data received, the lenalidomide plus obinutuzumab is well-tolerated in previously treated patients with relapsed or refractory follicular lymphoma, including those with early relapse, and has a manageable safety profile.


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