TevaGastrim for Stem Cell Mobilization Sibling Donors
This study is ongoing, but not recruiting participants.
Sponsor:
Sheba Medical Center
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01542944
First received: February 19, 2012
Last updated: November 22, 2013
Last verified: November 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia Myelodysplastic Syndrome |
Drug: TevaGastrim |
Phase 2 |
| Study Type: | Interventional |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
core binding factor acute myeloid leukemia
cytogenetically normal acute myeloid leukemia
familial acute myeloid leukemia with mutated CEBPA
Genetic and Rare Diseases Information Center resources:
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Acute Non Lymphoblastic Leukemia
Leukemia, Myeloid
Myelodysplastic Syndromes
U.S. FDA Resources
Further study details as provided by Sheba Medical Center:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 24 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TevaGastrim
treatment with TevaGastrim for allogeneic stem cell collection
|
Drug: TevaGastrim
TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542944
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542944
Locations
| Israel | |
| Chaim Sheba Medical Center | |
| Tel-Hashomer, Israel, 52621 | |
Sponsors and Collaborators
Sheba Medical Center
Investigators
| Principal Investigator: | Arnon Nagler, MD | Chaim Sheba Medical Center |
More Information
No publications provided
| Responsible Party: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT01542944 History of Changes |
| Other Study ID Numbers: | SHEBA-11-9090-AN-CTIL |
| Study First Received: | February 19, 2012 |
| Last Updated: | November 22, 2013 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
Acute myeloid leukemia Myelodysplastic syndrome Stem Cell Mobilization Allogeneic Stem Cell Transplantation |
Additional relevant MeSH terms:
|
Leukemia, Myeloid, Acute Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases |
Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type Precancerous Conditions |
ClinicalTrials.gov processed this record on March 03, 2015