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

This study is ongoing, but not recruiting participants.

First Received: June 21, 2005 Last Updated: February 12, 2009 History of Changes

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Pegfilgrastim

U.S. FDA Resources

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 Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

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:

Amgen

More Information

Additional Information:

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

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020134
Study First Received:	June 21, 2005
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00115193 History of Changes
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:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Neutropenia
Immunoproliferative Disorders

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on July 02, 2009