Pegfilgrastim vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-lymphoma
This study has been completed.
Sponsor:
South West German Cancer Center
Information provided by (Responsible Party):
Prof. Dr. R. Möhle, South West German Cancer Center
ClinicalTrials.gov Identifier:
NCT00306111
First received: March 20, 2006
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin Lymphoma |
Drug: pegfilgrastim |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Bio-equivalence Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by South West German Cancer Center:
Primary Outcome Measures:
- Hematopoietic recovery after autologous stem cell transplantation [ Time Frame: 1-3 weeks after transplantation, follow up every 3 months (up to 2 years) ] [ Designated as safety issue: No ]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:
- Intraindividual comparison of quantity/quality of circulating stem cells [ Time Frame: before and during 3 weeks after conventional chemotherapy ] [ Designated as safety issue: No ]Circulating stem cells are enumerated by flow cytometry and colony assays during filgrastim (intraindividual control) and pegfilgrastim-supported recovery from chemotherapy.
| Enrollment: | 14 |
| Study Start Date: | January 2006 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pegfilgrastim
Pegfilgrastim for stem cell mobilization (single arm)
|
Drug: pegfilgrastim
Single dose (6mg) one day after chemotherapy
Other Name: Neulasta(tm)
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306111
Locations
| Germany | |
| Dept. of Medicine 2, University of Tuebingen | |
| Tuebingen, BW, Germany, 72076 | |
Sponsors and Collaborators
South West German Cancer Center
Investigators
| Principal Investigator: | Robert Mohle, MD | University of Tuebingen, Dept. of Medicine 2 |
More Information
No publications provided
| Responsible Party: | Prof. Dr. R. Möhle, Oberarzt, South West German Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00306111 History of Changes |
| Other Study ID Numbers: | rpm_001 |
| Study First Received: | March 20, 2006 |
| Last Updated: | December 21, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by South West German Cancer Center:
|
stem cell transplantation stem cell mobilization high-dose therapy |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013