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

May 28, 2014 updated by: Prof. Dr. med. Wolfgang Bethge, University Hospital Tuebingen

Pegfilgrastim Versus Filgrastim - Intraindividual Comparison of Quantity and Quality of Mobilized Peripheral Blood Stem Cells in Patients With Non Hodgkin-lymphoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tuebingen, BW, Germany, 72076
        • Dept. of Medicine 2, University of Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pegfilgrastim
Pegfilgrastim for stem cell mobilization (single arm)
Drug: pegfilgrastim
Single dose (6mg) one day after chemotherapy
Other Names:
  • Neulasta(tm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-3 weeks after transplantation, follow up every 3 months (up to 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before and during 3 weeks after conventional chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Robert Mohle, MD, University of Tuebingen, Dept. of Medicine 2

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

March 20, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rpm_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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