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

Primary Purpose

Non-Hodgkin Lymphoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
pegfilgrastim
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring stem cell transplantation, stem cell mobilization, high-dose therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Dept. of Medicine 2, University of Tuebingen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pegfilgrastim

Arm Description

Pegfilgrastim for stem cell mobilization (single arm)

Outcomes

Primary Outcome Measures

Hematopoietic recovery after autologous stem cell transplantation
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
Circulating stem cells are enumerated by flow cytometry and colony assays during filgrastim (intraindividual control) and pegfilgrastim-supported recovery from chemotherapy.

Full Information

First Posted
March 20, 2006
Last Updated
May 28, 2014
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00306111
Brief Title
Pegfilgrastim vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-lymphoma
Official Title
Pegfilgrastim Versus Filgrastim - Intraindividual Comparison of Quantity and Quality of Mobilized Peripheral Blood Stem Cells in Patients With Non Hodgkin-lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
Keywords
stem cell transplantation, stem cell mobilization, high-dose therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pegfilgrastim
Arm Type
Experimental
Arm Description
Pegfilgrastim for stem cell mobilization (single arm)
Intervention Type
Drug
Intervention Name(s)
pegfilgrastim
Other Intervention Name(s)
Neulasta(tm)
Intervention Description
Single dose (6mg) one day after chemotherapy
Primary Outcome Measure Information:
Title
Hematopoietic recovery after autologous stem cell transplantation
Description
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
Time Frame
1-3 weeks after transplantation, follow up every 3 months (up to 2 years)
Secondary Outcome Measure Information:
Title
Intraindividual comparison of quantity/quality of circulating stem cells
Description
Circulating stem cells are enumerated by flow cytometry and colony assays during filgrastim (intraindividual control) and pegfilgrastim-supported recovery from chemotherapy.
Time Frame
before and during 3 weeks after conventional chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Mohle, MD
Organizational Affiliation
University of Tuebingen, Dept. of Medicine 2
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Medicine 2, University of Tuebingen
City
Tuebingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

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

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