Graft Versus Host Disease
Conditions
Keywords
Prograf, Graft versus host disease, Hematopoietic stem cell transplantation, Prophylaxis, Peripheral hematopoietic stem cell transplantation
Brief summary
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.
Interventions
DRUGPrograf
Injection or oral
DRUGMethotrexate
Injection
DRUGCyclosporine
Injection or oral
Sponsors
Astellas Pharma Korea, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Blood diseases for a standard risk group * Primary remission of AML (acute myeloid leukemia) * Primary remission of ALL (acute lymphocytic leukemia) * Secondary remission of ALL (acute lymphocytic leukemia) * SAA (severe aplastic anemia) * Chronic stage CML (chronic myeloid leukemia) * MDS (myelodysplastic syndrome) * Myeloma (multiple myeloma) * A patient who received peripheral hematopoietic stem cell transplantation from a HLA-matched sibling donor
Exclusion criteria
* A patient with renal impairment (serum creatinine level ≥ 1.5mg/dl or 130μmol/l, GFR≤ 30%) * A pregnant or breastfeeding woman * A woman who is unwilling or unable to practice appropriate contraception during the study * A patient who is highly likely to experience aggravation during treatment due to active tuberculosis, other hepatic disease, hypertension, heart failure, chronic obstructive respiratory disease, etc. * A patient with hypersensitivity to tacrolimus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by laboratory assessments | Day 1 up to 1 year post-transplant | Includes hematology, biochemistry and trough plasma concentration analysis |
| Classification 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 | 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). |
| Safety as assessed by adverse events | Day 1 up to 1 year post-transplant | — |
| 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 | Day 1 up to Day 100 post-transplant | 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. |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor in comparison with Cyclosporine in combination with MTX | Day 1 up to 1 year post-transplant |
| Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor | Day 1 up to 1 year post-transplant |
Countries
South Korea
Outcome results
None listed