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Home > "P" Clinical Trials Conditions > Pegfilgrastim PBPC Mobilization Study  Pegfilgrastim PBPC Mobilization Study
Pegfilgrastim PBPC Mobilization Study
For Condition: Lymphoma,Oncology,Lymphoma, Non-Hodgkin,Hodgkin Disease,Hematology
Status: No longer recruiting
Sponsor(s): Amgen ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant
Total Enrollment:
Location and Contact Information:
Research Site
St. Louis, Missouri,
United States
Research Site
Philadelphia, Pennsylvania,
United States
Research Site
Maywood, Illinois,
United States
Research Site
New York City, New York,
United States
Research Site
Miami, Florida,
United States
Research Site
Los Angeles, California,
United States
Research Site
Detroit, Michigan,
United States
Research Site
Chapel Hill, North Carolina,
United States
Research Site
Duarte, California,
United States
Additional Information:
Study ID Numbers: 20020112;
Study Start Date: November 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066092
Other Lymphoma, Non-Hodgkin Studies:
1. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
2. Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors
3. Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
4. Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
5. Evaluation of Bay 59-8862 in Patients with Aggressive, Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other Lymphoma, Non-Hodgkin Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Pegfilgrastim PBPC Mobilization Study
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