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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TevaGastrim | Experimental | treatment with TevaGastrim for allogeneic stem cell collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TevaGastrim | Drug | TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnon Nagler, MD | Chaim Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 100 days |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |