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Sponsored by: |
University Hospital Tuebingen |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00306111 |
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 |
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Non-Hodgkin Lymphoma |
Drug: pegfilgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study |
Official Title: | Pegfilgrastim Versus Filgrastim - Intraindividual Comparison of Quantity and Quality of Mobilized Peripheral Blood Stem Cells in Patients With Non Hodgkin-Lymphoma |
Estimated Enrollment: | 34 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2007 |
Patients with Non Hodgkin-lymphoma undergoing stem cell mobilization for planned high-dose therapy will be treated with two cycles of chemotherapy (eg., VIPE: etoposide, ifosfamide, cisplatin, epirubicin), either followed by daily administration of filgrastim (first cycle) or pegfilgrastim (once after the second cycle). The number of circulating CD34+ 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 TBI-containing regimens).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert Mohle, MD | 49-7071-2982726 | robert.moehle@med.uni-tuebingen.de |
Germany, BW | |
Dept. of Medicine 2, University of Tuebingen | Recruiting |
Tuebingen, BW, Germany, 72076 | |
Contact: Robert Mohle, MD 49-7071-2982726 robert.moehle@med.uni-tuebingen.de |
Principal Investigator: | Robert Mohle, MD | University of Tuebingen, Dept. of Medicine 2 |
Study ID Numbers: | rpm_001 |
Study First Received: | March 20, 2006 |
Last Updated: | March 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00306111 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
stem cell transplantation stem cell mobilization high-dose therapy |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Immunoproliferative Disorders |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |