Pegfilgrastim Versus Filgrastim After High-Dose Chemotherapy - Full Text View

Sponsored by:	Istituto Clinico Humanitas
Information provided by:	Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00410696

Purpose

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.

Condition	Intervention	Phase
Hematological Neoplasms Tumors	Drug: Filgrastim Drug: Pegfilgrastim	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Filgrastim Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:

Duration of aplasia period [ Time Frame: At time of discharge from Unit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunological reconstitution [ Time Frame: 1 year after transplantation ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	September 2006
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Filgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days)	Drug: Filgrastim 5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
B: Experimental Pegfilgrastim administered the day after autologous stem-cell reinfusion	Drug: Pegfilgrastim 6 mg/day sc at day +1

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410696

Locations

Italy, Milan
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

Study Director:

Armando Santoro, MD

Istituto Clinico Humanitas

More Information

Publications:

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.

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.

Responsible Party:	Istituto Clinico Humanitas ( Armando Santoro, MD )
Study ID Numbers:	ONC-2006-001, EUDRACT 2006-001409-27
Study First Received:	December 12, 2006
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00410696 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Istituto Clinico Humanitas:

High-dose chemotherapy
Growth factor
Pegfilgrastim

Study placed in the following topic categories:

Hematologic Neoplasms
Hematologic Diseases
Mitogens

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Hematologic Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on May 06, 2009