- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00306111
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
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
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BW
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Tuebingen, BW, Germany, 72076
- Dept. of Medicine 2, University of Tuebingen
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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)
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Single dose (6mg) one day after chemotherapy
Other Names:
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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)
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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
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1-3 weeks after transplantation, follow up every 3 months (up to 2 years)
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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
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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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before and during 3 weeks after conventional chemotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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