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

Phase 2

Completed

• Conditions: Non-Hodgkin Lymphoma
• Interventions: Drug: pegfilgrastim

• Registration Number: NCT00306111
• Lead Sponsor: University Hospital Tuebingen

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).

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-22
• Primary Completion: 2008-12
• Study Completion: 2011-12
• Status Verified: 2012-12
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pegfilgrastim	pegfilgrastim	Pegfilgrastim for stem cell mobilization (single arm)

Primary Outcome Measures

Name	Time	Method
Hematopoietic recovery after autologous stem cell transplantation	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

Secondary Outcome Measures

Name	Time	Method
Intraindividual comparison of quantity/quality of circulating stem cells	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.

Trial Locations

Locations (1)

Dept. of Medicine 2, University of Tuebingen; 🇩🇪 Tuebingen, BW, Germany