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

Graft Versus Host Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660684
• Other study ID #: PRG-07-11-KOR
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2016
• Last updated: February 29, 2016
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Prograf
Injection or oral
• Methotrexate
Injection
• Cyclosporine
Injection or oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Safety as assessed by adverse events		Day 1 up to 1 year post-transplant	No
Primary	Safety as assessed by laboratory assessments	Includes hematology, biochemistry and trough plasma concentration analysis	Day 1 up to 1 year post-transplant	No
Secondary	Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor		Day 1 up to 1 year post-transplant	No
Secondary	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	No

External Links

•   Link to results on Astellas Clinical Study Results Web site