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

February 29, 2016 updated by: Astellas Pharma Korea, Inc.

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of
    • Gyeongsangnam-do
      • Daegu, Gyeongsangnam-do, Korea, Republic of
    • Jeonranam-do
      • Hwasun-gun, Jeonranam-do, Korea, Republic of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prograf + MTX
Injection or oral
Other Names:
  • Tacrolimus
Injection
Active Comparator: Cyclosporine + MTX (historical control)
Injection
Injection or oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Day 1 up to Day 100 post-transplant
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
Time Frame: 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.
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
Time Frame: Day 100 up to 1 year post-transplant
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
Time Frame: 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).
Day 100 up to 1 year post-transplant
Safety as assessed by adverse events
Time Frame: Day 1 up to 1 year post-transplant
Day 1 up to 1 year post-transplant
Safety as assessed by laboratory assessments
Time Frame: Day 1 up to 1 year post-transplant
Includes hematology, biochemistry and trough plasma concentration analysis
Day 1 up to 1 year post-transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor
Time Frame: Day 1 up to 1 year post-transplant
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
Time Frame: Day 1 up to 1 year post-transplant
Day 1 up to 1 year post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

January 18, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

February 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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