Feasibility and Cost Analysis of PBSC Mobilization Using Pegfilgrastim in Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT00689884|
Recruitment Status : Terminated (Lack of enrollment.)
First Posted : June 4, 2008
Results First Posted : August 31, 2012
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Drug: Pegfilgrastim||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Feasibility and Cost Analysis of Peripheral Blood Stem Cell Mobilization Using Pegfilgrastim in Patients With Hematologic Malignancies|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Experimental: Group A
All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
Pegfilgrastim: Sub Cutaneous, 6 mg on Day 3 of chemotherapy regimen or as otherwise indicated by chemotherapy regimen (ie., 24 hours after completion of chemotherapy).
Other Name: Neulasta
- Efficacy of Pegfilgrastim in the Mobilization of Autologous Peripheral Blood Stem Cells (PBSCs), Defined as Cell Yield ≥ 3 x 10e6 CD34+/kg [ Time Frame: 2 years ]Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
- Assess the Per-patient Costs Related to Pegfilgrastim Use in the Mobilization of Autologous PBSCs in 16 Study Participants. [ Time Frame: At each stage of pheresis for each enrolled subject for a maximum of 2 years. ]Costs will be divided into three categories: 1. Pre-pheresis preparation (cost of Pegfilgrastim, laboratory testing, drug administration, providers, line placement); 2. Pheresis procedure (costs related to # collections and total hours on apheresis machine, microbiological testing, provider, CD34 analysis and related labs, cryopreservation/storage and complications); 3. Post-pheresis processing (cost of stem cell thawing, microbiological testing, CD34 analysis and related labs, providers, administration).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689884
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||John M Hill Jr., MD||Dartmouth-Hitchcock Medical Center|