drugset / Trial / NCT02044276
A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.
Timeline
- Start
- 2014-03-31
- Primary completion
- 2017-08-29
- Completion
- 2018-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Subject | lipegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |