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A randomized, open-label, two-arm, multicenter, comparatiVe study on efficacy and safety of lipegfilgrastim (Lonquex, TEVA) in comparison to pegfilgrastim (Neulasta®, Amgen) in elderly patients with a...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-001284-23

A randomized, open-label, two-arm, multicenter, comparatiVe study on efficacy and safety of lipegfilgrastim (Lonquex, TEVA) in comparison to pegfilgrastim (Neulasta®, Amgen) in elderly patients with aggressive B cell Non-HOdgkin lymphomas at hIgh risk for R-CHOP-21-inDuced neutropenia – AVOID Neutropenia

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Extrait

The primary objective of this study is to demonstrate non-inferiority of lipegfilgrastim (Lonquex, Teva) vs. pegfilgrastim (Neulasta®, Amgen) for the duration of severe neutropenia (DSN) in the first cycle of chemotherapy.

Critère d'inclusion

  • The study population includes patients with aggressive B cell Non-Hodgkin Lymphoma (NHL) planned to receive systemic anti-cancer therapy with at least 6 cycles of R-CHOP-21, according to local standards

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