TevaGastrim for Stem Cell Mobilization Sibling Donors
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ClinicalTrials.gov Identifier: NCT01542944 |
Recruitment Status :
Completed
First Posted : March 2, 2012
Last Update Posted : April 20, 2016
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Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia Myelodysplastic Syndrome | Drug: TevaGastrim | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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) |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

Arm | Intervention/treatment |
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Experimental: TevaGastrim
treatment with TevaGastrim for allogeneic stem cell collection
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Drug: TevaGastrim
TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis. |
- Mobilisation success rate [ Time Frame: 4 weeks ]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 ]speed of engraftment is determined by the time until recovery of blood counts after transplantation
- Donor safety [ Time Frame: 100 days ]To determine side effects to the stem cell donor

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542944
Israel | |
Chaim Sheba Medical Center | |
Tel-Hashomer, Israel, 52621 |
Principal Investigator: | Arnon Nagler, MD | Chaim Sheba Medical Center |
Responsible Party: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT01542944 |
Other Study ID Numbers: |
SHEBA-11-9090-AN-CTIL |
First Posted: | March 2, 2012 Key Record Dates |
Last Update Posted: | April 20, 2016 |
Last Verified: | April 2016 |
Acute myeloid leukemia Myelodysplastic syndrome Stem Cell Mobilization Allogeneic Stem Cell Transplantation |
Leukemia Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes |
Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |