NCT01542944

TevaGastrim for Stem Cell Mobilization Sibling Donors

TevaGastrim for Stem Cell Mobilization of HLA Matched Sibling Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	TevaGastrim	TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-03-02
• Last updated: 2016-04-20

Locations

1 site across 1 country: Israel