Back to resultsStudy 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
Primary Purpose
Graft Versus Host Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prograf
Methotrexate
Cyclosporine
Sponsored by
About this trial
This is an interventional treatment trial for Graft Versus Host Disease focused on measuring Prograf, Graft versus host disease, Hematopoietic stem cell transplantation, Prophylaxis, Peripheral hematopoietic stem cell transplantation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prograf + MTX
Cyclosporine + MTX (historical control)
Arm Description
Outcomes
Primary Outcome Measures
Number of occurrence sites of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
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.
Number of occurrence sites of chronic GVHD occurring after 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
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).
Safety as assessed by adverse events
Safety as assessed by laboratory assessments
Includes hematology, biochemistry and trough plasma concentration analysis
Secondary Outcome Measures
Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor
Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor in comparison with Cyclosporine in combination with MTX
Full Information
NCT ID
NCT02660684
First Posted
January 18, 2016
Last Updated
February 29, 2016
Sponsor
Astellas Pharma Korea, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02660684
Brief Title
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
Official Title
A Historically-controlled, Multi-center Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule, Prograf Injection) and Methotrexate Combination Therapy for Prevention of GVHD in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling Donor
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Korea, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
Keywords
Prograf, Graft versus host disease, Hematopoietic stem cell transplantation, Prophylaxis, Peripheral hematopoietic stem cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prograf + MTX
Arm Type
Experimental
Arm Title
Cyclosporine + MTX (historical control)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prograf
Other Intervention Name(s)
Tacrolimus
Intervention Description
Injection or oral
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Injection
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Description
Injection or oral
Primary Outcome Measure Information:
Title
Number of occurrence sites of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
Time Frame
Day 1 up to Day 100 post-transplant
Title
Severity of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
Description
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.
Time Frame
Day 1 up to Day 100 post-transplant
Title
Number of occurrence sites of chronic GVHD occurring after 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
Time Frame
Day 100 up to 1 year post-transplant
Title
Classification of chronic GVHD occurring after 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
Description
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).
Time Frame
Day 100 up to 1 year post-transplant
Title
Safety as assessed by adverse events
Time Frame
Day 1 up to 1 year post-transplant
Title
Safety as assessed by laboratory assessments
Description
Includes hematology, biochemistry and trough plasma concentration analysis
Time Frame
Day 1 up to 1 year post-transplant
Secondary Outcome Measure Information:
Title
Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor
Time Frame
Day 1 up to 1 year post-transplant
Title
Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor in comparison with Cyclosporine in combination with MTX
Time Frame
Day 1 up to 1 year post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Korea, Inc.
Official's Role
Study Director
Facility Information:
City
Daegu
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
City
Hwasun-gun
State/Province
Jeonranam-do
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=PRG-07-11-KOR
Description
Link to results on Astellas Clinical Study Results Web site
Learn more about this trial
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
We'll reach out to this number within 24 hrs