Pegfilgrastim Versus Filgrastim After High-Dose Chemotherapy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 12, 2006

Last Updated Date

December 1, 2008

Start Date ^†

September 2006

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00410696 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Pegfilgrastim Versus Filgrastim After High-Dose Chemotherapy

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

Brief 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.

Detailed Description

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hematological Neoplasms
Tumors

Intervention ^†

Drug: Filgrastim
Drug: Pegfilgrastim

Study Arms / Comparison Groups

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)
Experimental: Pegfilgrastim administered the day after autologous stem-cell reinfusion

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00410696

Responsible Party

Armando Santoro, MD, Istituto Clinico Humanitas

Secondary IDs ^††

EUDRACT 2006-001409-27

Study Sponsor ^†

Istituto Clinico Humanitas

Collaborators ^††

Investigators ^†

Study Director:

Armando Santoro, MD

Istituto Clinico Humanitas

Information Provided By

Istituto Clinico Humanitas

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.