AVOID : Essai de phase 3 randomisé, comparant l’efficacité et la tolérance du lipegfilgrastim à celle du pegfilgrastim, chez des patients âgés ayant un lymphome non-hodgkinien agressif à cellules B à haut risque de neutropénie et traité par une chimiothérapie de type R-CHOP-21. [essai clos aux inclusions] L’objectif de cet essai est de comparer l’efficacité et la tolérance du lipegfilgrastim et du pegfilgrastim, chez des patients âgés ayant un lymphome non-hodgkinien agressif à cellules B et à haut ris...

• Country France
• organs Lymphomes non hodgkinien
• Specialty Chimiothérapie, Gériatrie

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 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 ...

• Country None
• organs None
• Specialty None

A Study to Assess the Pharmacokinetics (absorption, distribution, metabolisation, excretion), Pharmacodynamics (biochemical and physiological effects of the drug), Efficacy, Safety, Tolerability, and Immunogenicity (Immune response) of a Single, Subcutaneous Dose of 100μg/kg XM22 in 21 Children with Ewing Family of Tumors or Rhabdomyosarcoma The primary objective of the study is to assess the pharmacokinetics (PK) of a single subcutaneous (SC) injection of XM22, 100 μg/kg body weight (BW), in children with Ewing family of tumors or rhabdo...

• Country None
• organs None
• Specialty None

AVOID : Essai de phase 3 randomisé, comparant l’efficacité et la tolérance du lipegfilgrastim à celle du pegfilgrastim, chez des patients âgés ayant un lymphome non-hodgkinien agressif à cellules B à haut risque de neutropénie et traité par une chimiothérapie de type R-CHOP-21. L’objectif de cet essai est de comparer l’efficacité et la tolérance du lipegfilgrastim et du pegfilgrastim, chez des patients âgés ayant un lymphome non-hodgkinien agressif à cellules B et à haut ris...

• Country France
• organs Lymphomes non hodgkinien
• Specialty Chimiothérapie, Gériatrie

Clinical trial comparing Lipegfilgrastim to Filgrastim in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy The primary objective of this study is to assess the efficacy of a single subcutaneous (sc) dose of 100 μg/kg body weight (BW) of lipegfilgrastim per cycle compared to daily 5 μg/kg BW of filgrastim d...

• Country None
• organs None
• Specialty None

A phase 4 clinical study to compare the safety and efficacy of LONQUEX® with NEULASTA® and Placebo in patients with Non-Small-Cell Lung Cancer treated with first-line chemotherapy To collect comparative data for LONQUEX®, Neulasta® and placebo in patients with advanced squamous or non-squamous NSCLC Stage IIIB/IV, including full details of disease progression (whether or not le...

• Country None
• organs None
• Specialty None