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

Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306111
• Other study ID #: rpm_001
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2006
• Last updated: May 28, 2014
• Start date: January 2006
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2011
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• pegfilgrastim
Single dose (6mg) one day after chemotherapy

Locations

Country	Name	City	State
Germany	Dept. of Medicine 2, University of Tuebingen	Tuebingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-3 weeks after transplantation, follow up every 3 months (up to 2 years)	No
Secondary	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.	before and during 3 weeks after conventional chemotherapy	No