Pegfilgrastim vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306111
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : May 29, 2014
Information provided by (Responsible Party):
Prof. Dr. med. Wolfgang Bethge, University Hospital Tuebingen

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Drug: pegfilgrastim Phase 2

Detailed Description:
Patients with Non Hodgkin-lymphoma undergoing stem cell mobilization for planned high-dose therapy will be treated with two cycles of chemotherapy (etoposide, ifosfamide, cisplatin, epirubicin), either followed by daily administration of filgrastim (first cycle) or pegfilgrastim (once after the second cycle). The number of circulating cluster of differentiation 34+ 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 total body irradiation-containing regimens).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pegfilgrastim Versus Filgrastim - Intraindividual Comparison of Quantity and Quality of Mobilized Peripheral Blood Stem Cells in Patients With Non Hodgkin-lymphoma
Study Start Date : January 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pegfilgrastim
Pegfilgrastim for stem cell mobilization (single arm)
Drug: pegfilgrastim
Single dose (6mg) one day after chemotherapy
Other Name: Neulasta(tm)

Primary Outcome Measures :
  1. Hematopoietic recovery after autologous stem cell transplantation [ Time Frame: 1-3 weeks after transplantation, follow up every 3 months (up to 2 years) ]
    Two cycles of conventional chemotherapy are given. Starting one day after the first cycle, filgrastim (5ug/kg bodyweight daily subcutaneously) is routinely administered to support neutrophil recovery. One day after the second cycle, a single dose of pegfilgrastim (6mg) is given to support neutrophil recovery and stem cell collection. Hematopoietic recovery (blood count) is monitored daily after high-dose therapy and autologous stem cell transplantation. Follow up assessments are performed 3-monthly for late graft failure

Secondary Outcome Measures :
  1. Intraindividual comparison of quantity/quality of circulating stem cells [ Time Frame: before and during 3 weeks after conventional chemotherapy ]
    Circulating stem cells are enumerated by flow cytometry and colony assays during filgrastim (intraindividual control) and pegfilgrastim-supported recovery from chemotherapy.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • allergy against (peg)filgrastim
  • life expectancy <3 months
  • other malignant diseases within the last 5 years
  • cardial insufficiency (>= New York Heart Association II°)
  • uncontrolled infection
  • pregnancy, lactation
  • central nervous system lymphoma
  • Karnofsky score <70%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306111

Dept. of Medicine 2, University of Tuebingen
Tuebingen, BW, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Robert Mohle, MD University of Tuebingen, Dept. of Medicine 2

Responsible Party: Prof. Dr. med. Wolfgang Bethge, Oberarzt, University Hospital Tuebingen Identifier: NCT00306111     History of Changes
Other Study ID Numbers: rpm_001
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: December 2012

Keywords provided by Prof. Dr. med. Wolfgang Bethge, University Hospital Tuebingen:
stem cell transplantation
stem cell mobilization
high-dose therapy

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs