Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule/Injection) and Methotrexate (MTX) Combination Therapy for Prevention of Graft Versus Host Disease (GVHD) in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling Donor
NCT ID: NCT02660684
Last Updated: 2016-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
39 participants
INTERVENTIONAL
2008-02-29
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prograf + MTX
Prograf
Injection or oral
Methotrexate
Injection
Cyclosporine + MTX (historical control)
Methotrexate
Injection
Cyclosporine
Injection or oral
Interventions
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Prograf
Injection or oral
Methotrexate
Injection
Cyclosporine
Injection or oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Korea, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Korea, Inc.
Locations
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Daegu, Gyeongsangnam-do, South Korea
Hwasun-gun, Jeonranam-do, South Korea
Seoul, , South Korea
Countries
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Related Links
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Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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PRG-07-11-KOR
Identifier Type: -
Identifier Source: org_study_id
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