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| Sponsored by: |
Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00066092 |
Purpose
This is a randomized, double-blind, multi-center study to assess the safety and effectiveness of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Hematology Oncology |
Drug: pegfilgrastim 12 mg Drug: filgrastim Drug: pegfilgrastim 6 mg |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Hodgkin's or Non-Hodgkin's Lymphoma. |
| Enrollment: | 41 |
| Study Start Date: | April 2003 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Pegfilgrastim 6 mg: Experimental
Pegfilgrastim 6 mg given once for PBPC mobilization
|
Drug: pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for PBPC mobilization
|
|
Pegfilgrastim 12 mg: Experimental
Pegfilgrastim 12 mg given once for PBPC mobilization
|
Drug: pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for PBPC mobilization
|
|
filgrastim: Active Comparator
Filgrastim given daily for PBPC mobilization
|
Drug: filgrastim
Filgrastim given daily for PBPC mobilization
|
This is a research study for Hodgkin's Disease and Non-Hodgkin's Lymphoma (NHL) patients who will receive high-dose chemotherapy with autologous peripheral blood stem cell (PBSC or PBPC) transplant. The chemotherapy doses are high enough to severely suppress the bone marrow (where blood cells are made) and cause very low blood counts. A collection of stem cells (very young blood cells) followed by reinfusion to restore blood counts will be done to stimulate recovery of your blood counts. This procedure is called leukapheresis. Giving growth factors to patients is a method to increase the number of PBPC that can be collected during leukapheresis. This process of giving growth factors to patients is called mobilization (moving cells from the bone marrow to the peripheral blood where they can be collected). The purpose of this study is to determine if pegfilgrastim, an investigational drug, can safely and effectively mobilize stem cells. Filgrastim (also known as NEUPOGEN® or G-CSF) is approved by the FDA for stem cell mobilization.
Pegfilgrastim is a modified version of Filgrastim that is longer acting.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20020112 |
| Study First Received: | August 4, 2003 |
| Last Updated: | February 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066092 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
PBPC transplant Hodgkin's Disease Non-Hodgkin's Lymphoma NHL mobilization |
|
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hodgkin's Disease |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Hodgkin Disease Lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Hodgkin Disease |
