Pegfilgrastim Vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-Lymphoma - Full Text View

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00306111

Purpose

The purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to mobilize peripheral blood stem cells in patients with Non Hodgkin-lymphoma in an intraindividual study

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

MedlinePlus related topics: Lymphoma

Drug Information available for: Filgrastim Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study
Official Title:	Pegfilgrastim Versus Filgrastim - Intraindividual Comparison of Quantity and Quality of Mobilized Peripheral Blood Stem Cells in Patients With Non Hodgkin-Lymphoma

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Hematopoietic recovery after autologous stem cell transplantation

Secondary Outcome Measures:

Intraindividual comparison of quantity/quality of circulating stem cells

Estimated Enrollment:	34
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2007

Detailed Description:

Patients with Non Hodgkin-lymphoma undergoing stem cell mobilization for planned high-dose therapy will be treated with two cycles of chemotherapy (eg., VIPE: etoposide, ifosfamide, cisplatin, epirubicin), either followed by daily administration of filgrastim (first cycle) or pegfilgrastim (once after the second cycle). The number of circulating CD34+ cells, colony-forming units and primitive progenitors will be analyzed at corresponding time points. Peripheral blood stem cells will be collected after the second cycle of chemotherapy by leukapheresis. After the second cycle, high-dose therapy with peripheral blood stem cell support will be administered (the protocol will be chosen according to the diagnosis, including TBI-containing regimens).

Eligibility

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

Criteria

Inclusion Criteria:

histological diagnosis of non-Hodgkin lymphoma
planned high-dose therapy with autologous stem cell transplantation
WHO PS 0-2
written consent

Exclusion Criteria:

allergy against (peg)filgrastim
life expectancy <3 months
other malignant diseases within the last 5 years
cardial insufficiency (>= NYHA II°)
uncontrolled infection
pregnancy, lactation
CNS lymphoma
Karnofsky score <70%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306111

Contacts

Contact: Robert Mohle, MD

49-7071-2982726

robert.moehle@med.uni-tuebingen.de

Locations

Germany, BW
Dept. of Medicine 2, University of Tuebingen	Recruiting
Tuebingen, BW, Germany, 72076
Contact: Robert Mohle, MD 49-7071-2982726 robert.moehle@med.uni-tuebingen.de

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Robert Mohle, MD

University of Tuebingen, Dept. of Medicine 2

More Information

Study ID Numbers:	rpm_001
Study First Received:	March 20, 2006
Last Updated:	March 20, 2006
ClinicalTrials.gov Identifier:	NCT00306111
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

stem cell transplantation
stem cell mobilization
high-dose therapy

Study placed in the following topic categories:

Lymphatic Diseases
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 January 14, 2009