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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: pegfilgrastim


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegfilgrastim<br>Pegfilgrastim for stem cell mobilization (single arm) | Drug: pegfilgrastim<br>* Single dose (6mg) one day after chemotherapy<br>* Other names: Neulasta(tm);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cell transplantation, stem cell mobilization, high-dose therapy