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

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Completed
CT.gov ID
NCT00306111
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
71
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pegfilgrastim Versus Filgrastim - Intraindividual Comparison of Quantity and Quality of Mobilized Peripheral Blood Stem Cells in Patients With Non Hodgkin-lymphoma
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pegfilgrastim

Pegfilgrastim for stem cell mobilization (single arm)

Drug: pegfilgrastim
Single dose (6mg) one day after chemotherapy
Other Names:
  • Neulasta(tm)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Medicine 2, University of Tuebingen Tuebingen BW Germany 72076

    Sponsors and Collaborators

    • University Hospital Tuebingen

    Investigators

    • Principal Investigator: Robert Mohle, MD, University of Tuebingen, Dept. of Medicine 2

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. med. Wolfgang Bethge, Oberarzt, University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT00306111
    Other Study ID Numbers:
    • rpm_001
    First Posted:
    Mar 22, 2006
    Last Update Posted:
    May 29, 2014
    Last Verified:
    Dec 1, 2012
    Keywords provided by Prof. Dr. med. Wolfgang Bethge, Oberarzt, University Hospital Tuebingen
    stem cell transplantation
    stem cell mobilization
    high-dose therapy
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin

    Study Results

    No Results Posted as of May 29, 2014