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The purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Stem cell Transplant using two unrelated umbilical cord blood units. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem cell Transplantation | Drug | Busulfan: 3.2 mg/kg IV daily on days -7 to -4 Cyclophosphamide : 60 mg/m² daily on days -3 to -2 Rabbit Thymoglobulin 2.5mg/kg IV daily on days -3 to -2 Cyclosporin will begin on day -2 (IV or oral) for at least 180 days. Target trough level for cyclosporin is 200 ng/ml. In the absence of GVHD, Cyclosporin tapering will begin on day +90 Methyl prednisolone (1mg/kg/d IV) will begin on day -2 to +7 and then 0.5mg/kg until +14 posttransplant. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies | Until end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Neutrophil and platelet engraftment | 1 year | |
| Severity of acute graft-vs-host disease(GvHD | 1 year | |
| Early transplant related mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ardeshir Ghavamzadeh, MD | Contact | 84902635 | +98-21 | ghavamza@sina.tums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Amir Ali Hamidieh, MD | Hematology-Oncology and SCT Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology-Oncology & SCT Research Center | Recruiting | Tehran | Tehran Province | 14114 | Iran |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| 100 days |
| Overall and disease free survival at one years | 1 year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |