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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin Lymphoma

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Trial Information

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


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).


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%

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Hematopoietic recovery after autologous stem cell transplantation

Outcome 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

Outcome Time Frame:

1-3 weeks after transplantation, follow up every 3 months (up to 2 years)

Safety Issue:

No

Principal Investigator

Robert Mohle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Tuebingen, Dept. of Medicine 2

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

rpm_001

NCT ID:

NCT00306111

Start Date:

January 2006

Completion Date:

December 2011

Related Keywords:

  • Non-Hodgkin Lymphoma
  • stem cell transplantation
  • stem cell mobilization
  • high-dose therapy
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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