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The objective of this study is to assess the safety and efficacy of Tacrolimus (Prograf capsule, Prograf injection) and Methotrexate combination therapy for GVHD prophylaxis in patients who received peripheral hematopoietic stem cell transplantation from a sibling donor, and to compare with data from a historical control group that administered a conventional Cyclosporine formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prograf + MTX | Experimental |
| |
| Cyclosporine + MTX (historical control) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prograf | Drug | Injection or oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of occurrence sites of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor | Day 1 up to Day 100 post-transplant | |
| Severity of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor | Severity is graded according to the Seattle criteria, between 1+ ~ 4+ depending on the severity of the injury of the skin, liver and digestive system, and the overall grade is classified by including the performance change. | Day 1 up to Day 100 post-transplant |
| Number of occurrence sites of chronic GVHD occurring after 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor | Day 100 up to 1 year post-transplant | |
| Classification of chronic GVHD occurring after 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor | Depending on the extent of occurrence, it is classified as limited (present only locally) and extensive (systemic lesions). Depending on the presence of preceding acute GVHD, it is classified as progressive for a patient with preceding acute GVHD (chronic GVHD following the occurrence of acute GVHD), quiescent (chronic GVHD after relief of acute GVHD symptoms) or otherwise (de novo). | Day 100 up to 1 year post-transplant |
| Safety as assessed by adverse events | Day 1 up to 1 year post-transplant | |
| Safety as assessed by laboratory assessments | Includes hematology, biochemistry and trough plasma concentration analysis | Day 1 up to 1 year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor | Day 1 up to 1 year post-transplant | |
| Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor in comparison with Cyclosporine in combination with MTX |
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Inclusion Criteria:
Blood diseases for a standard risk group
A patient who received peripheral hematopoietic stem cell transplantation from a HLA-matched sibling donor
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Korea, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daegu | Gyeongsangnam-do | South Korea | ||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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| Methotrexate | Drug | Injection |
|
| Cyclosporine | Drug | Injection or oral |
|
| Day 1 up to 1 year post-transplant |
| Hwasun-gun |
| Jeonranam-do |
| South Korea |
| Seoul | South Korea |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D008727 | Methotrexate |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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