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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Hematological Neoplasms, Tumors
Both
Hematological Neoplasms, Tumors
Trial Information
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
Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and
filgrastim.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Duration of aplasia period
Outcome Time Frame:
At time of discharge from Unit
Safety Issue:
Yes
Principal Investigator
Armando Santoro, MD
Investigator Role:
Study Director
Investigator Affiliation:
Istituto Clinico Humanitas
Authority:
Italy: Ministry of Health
Study ID:
ONC-2006-001
NCT ID:
NCT00410696
Start Date:
September 2006
Completion Date:
November 2008
Related Keywords:
- Hematological Neoplasms
- Tumors
- High-dose chemotherapy
- Growth factor
- Pegfilgrastim
- Neoplasms
- Hematologic Neoplasms
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