Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma - Full Text View

Purpose

The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: pegfilgrastim	Phase II

MedlinePlus related topics:

Lymphoma

Drug Information available for:

Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Single Group Assignment, Bio-availability Study

Official Title:	A Multicenter, Double-Blind, Randomized Study of Pegfilgrastim Administered on the Same Day or the Next Day of R-Chop Chemotherapy in Subjects With Non-Hodgkin's Lymphoma

Further study details as provided by Amgen:

Primary Outcome Measures:

Reduce the duration of neutropenia and incidence of febrile neutropenia.

Secondary Outcome Measures:

On the same day as chemotherapy as measured by the incidence of hematologic and non-hematologic toxicities, the number of subjects who received planned doses of chemotherapy on time and response rates.

Study Start Date:	February 2003
Estimated Study Completion Date:	September 2005

Eligibility

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

Criteria

Inclusion Criteria: - Histologically proven mantle cell lymphoma or histologically proven diffuse large B-cell non-Hodgkin's lymphoma (NHL) according to the REAL classification - Measurable and/or evaluable disease - Previously untreated patients Exclusion Criteria: - Burkitt's or B-lymphoblastic lymphoma - Central nervous system (CNS) involvement - Active infection requiring treatment with systemic anti-infectives within 72 hours of chemotherapy - Prior malignancy within the last 5 years - T-cell lymphoma or history of indolent lymphoma - Prior bone marrow or stem cell transplantation - Known sensitivity to E. coli derived drug products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115193

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020134
First Received:	June 21, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00115193
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Oncology

NHL

Mantle cell

Diffuse large B-cell

Chemotherapy

RCHOP

Neulasta®

Neutropenia

Pegfilgrastim

Amgen

Study placed in the following topic categories:

Lymphatic Diseases

Neutropenia

Immunoproliferative Disorders

Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00115193