Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410696
• Other study ID #: ONC-2006-001
• Secondary ID: EUDRACT 2006-001
• Status: Completed
• Phase: Phase 2
• First received: December 12, 2006
• Last updated: June 28, 2013
• Start date: September 2006
• Est. completion date: November 2008

Study information

• Verified date: June 2013
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Neoplasms
• Tumors

Intervention

Drug:
• Filgrastim
5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
• Pegfilgrastim
6 mg/day sc at day +1

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Farese AM, Yang BB, Roskos L, Stead RB, MacVittie TJ. Pegfilgrastim, a sustained-duration form of filgrastim, significantly improves neutrophil recovery after autologous marrow transplantation in rhesus macaques. Bone Marrow Transplant. 2003 Aug;32(4):399-404. — View Citation

Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of aplasia period		At time of discharge from Unit	Yes
Secondary	Immunological reconstitution		1 year after transplantation	No