TevaGastrim for Stem Cell Mobilization Sibling Donors

Study Overview
=================
Brief 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.

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)

Conditions
-----------------
Acute Myeloid Leukemia, Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Drug: TevaGastrim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 70 years. Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and is eligible for allogeneic stem cell transplantation Written informed consent. Exclusion Criteria: Inability to tolerate PBPC harvest. Peripheral venous access not possible. Positive pregnancy test for female donors. Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR. Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study. Treatment with other investigational drugs. Known sensitivity to CHO derived products. HIV positive. History of malignant disease or current malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TevaGastrim<br>treatment with TevaGastrim for allogeneic stem cell collection | Drug: TevaGastrim<br>* TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobilisation success rate | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| engraftment after transplantation | speed of engraftment is determined by the time until recovery of blood counts after transplantation | 100 days | 
| Donor safety | To determine side effects to the stem cell donor | 100 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myeloid leukemia, Myelodysplastic syndrome, Stem Cell Mobilization, Allogeneic Stem Cell Transplantation