Back to resultsPegfilgrastim Versus Filgrastim After High-dose Chemotherapy
Primary Purpose
Hematological Neoplasms, Tumors
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Filgrastim
Pegfilgrastim
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Neoplasms focused on measuring High-dose chemotherapy, Growth factor, Pegfilgrastim
Eligibility Criteria
Inclusion Criteria:
- Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
- Adequate organ function
- Written informed consent.
Exclusion Criteria:
- Use of other experimental drugs
- Active infection
Sites / Locations
- Istituto Clinico Humanitas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Filgrastim
Pegfilgrastim
Arm Description
Filgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days)
Pegfilgrastim administered the day after autologous stem-cell reinfusion
Outcomes
Primary Outcome Measures
Duration of aplasia period
Secondary Outcome Measures
Immunological reconstitution
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00410696
Brief Title
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy
Official Title
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Armando Santoro, MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.
Detailed Description
Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Neoplasms, Tumors
Keywords
High-dose chemotherapy, Growth factor, Pegfilgrastim
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Filgrastim
Arm Type
Active Comparator
Arm Description
Filgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days)
Arm Title
Pegfilgrastim
Arm Type
Experimental
Arm Description
Pegfilgrastim administered the day after autologous stem-cell reinfusion
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Granulokine
Intervention Description
5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Neulasta
Intervention Description
6 mg/day sc at day +1
Primary Outcome Measure Information:
Title
Duration of aplasia period
Time Frame
At time of discharge from Unit
Secondary Outcome Measure Information:
Title
Immunological reconstitution
Time Frame
1 year after transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
Adequate organ function
Written informed consent.
Exclusion Criteria:
Use of other experimental drugs
Active infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Study Director
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
11821454
Citation
Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727.
Results Reference
background
PubMed Identifier
12900776
Citation
Farese AM, Yang BB, Roskos L, Stead RB, MacVittie TJ. Pegfilgrastim, a sustained-duration form of filgrastim, significantly improves neutrophil recovery after autologous marrow transplantation in rhesus macaques. Bone Marrow Transplant. 2003 Aug;32(4):399-404. doi: 10.1038/sj.bmt.1704156.
Results Reference
background
PubMed Identifier
20007996
Citation
Castagna L, Bramanti S, Levis A, Michieli MG, Anastasia A, Mazza R, Giordano L, Sarina B, Todisco E, Gregorini AI, Santoro A. Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support. Ann Oncol. 2010 Jul;21(7):1482-1485. doi: 10.1093/annonc/mdp576. Epub 2009 Dec 11.
Results Reference
derived
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Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy
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