Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial

The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.

Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.

Inclusion Criteria:

• Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
• Adequate organ function
• Written informed consent.

Exclusion Criteria:

• Use of other experimental drugs
• Active infection