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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Wolfgang Bethge, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00306111
First received: March 20, 2006
Last updated: May 28, 2014
Last verified: December 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Hematopoietic recovery after autologous stem cell transplantation [ Time Frame: 1-3 weeks after transplantation, follow up every 3 months (up to 2 years) ] [ Designated as safety issue: No ]
    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:
  • Intraindividual comparison of quantity/quality of circulating stem cells [ Time Frame: before and during 3 weeks after conventional chemotherapy ] [ Designated as safety issue: No ]
    Circulating stem cells are enumerated by flow cytometry and colony assays during filgrastim (intraindividual control) and pegfilgrastim-supported recovery from chemotherapy.


Enrollment: 14
Study Start Date: January 2006
Study Completion Date: December 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegfilgrastim
Pegfilgrastim for stem cell mobilization (single arm)
Drug: pegfilgrastim
Single dose (6mg) one day after chemotherapy
Other Name: Neulasta(tm)

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).

  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 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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Prof. Dr. med. Wolfgang Bethge, Oberarzt, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00306111     History of Changes
Other Study ID Numbers: rpm_001
Study First Received: March 20, 2006
Last Updated: May 28, 2014
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014