TevaGastrim for Stem Cell Mobilization Sibling Donors
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.
Acute Myeloid Leukemia
|Study Design:||Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Mobilisation success rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Mobilisation success rate is defined as the mobilisation of a PBSC graft containing >2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach >2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching >5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.
- engraftment after transplantation [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]speed of engraftment is determined by the time until recovery of blood counts after transplantation
- Donor safety [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]To determine side effects to the stem cell donor
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
treatment with TevaGastrim for allogeneic stem cell collection
TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.