Back to resultsTevaGastrim for Stem Cell Mobilization Sibling Donors
Primary Purpose
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
TevaGastrim
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid leukemia, Myelodysplastic syndrome, Stem Cell Mobilization, Allogeneic Stem Cell Transplantation
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.
Sites / Locations
- Chaim Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TevaGastrim
Arm Description
treatment with TevaGastrim for allogeneic stem cell collection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
engraftment after transplantation
speed of engraftment is determined by the time until recovery of blood counts after transplantation
Donor safety
To determine side effects to the stem cell donor
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01542944
Brief Title
TevaGastrim for Stem Cell Mobilization Sibling Donors
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Keywords
Acute myeloid leukemia, Myelodysplastic syndrome, Stem Cell Mobilization, Allogeneic Stem Cell Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TevaGastrim
Arm Type
Experimental
Arm Description
treatment with TevaGastrim for allogeneic stem cell collection
Intervention Type
Drug
Intervention Name(s)
TevaGastrim
Intervention Description
TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.
Primary Outcome Measure Information:
Title
Mobilisation success rate
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
engraftment after transplantation
Description
speed of engraftment is determined by the time until recovery of blood counts after transplantation
Time Frame
100 days
Title
Donor safety
Description
To determine side effects to the stem cell donor
Time Frame
100 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnon Nagler, MD
Organizational Affiliation
Chaim Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
TevaGastrim for Stem Cell Mobilization Sibling Donors
We'll reach out to this number within 24 hrs