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OpenTrials
Completed

NCT Number: NCT02660684

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

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.

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Key information

Conditions

Graft Versus Host Disease Graft vs Host Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Daegu, Gyeongsangnam-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prograf

Drug

Injection or oral

Other names: Tacrolimus

methotrexate

Drug

Injection

cyclosporine

Drug

Injection or oral

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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).

  5. Safety as assessed by adverse events

    Time frame: Day 1 up to 1 year post-transplant

  6. Safety as assessed by laboratory assessments

    Time frame: Day 1 up to 1 year post-transplant

    Includes hematology, biochemistry and trough plasma concentration analysis

Secondary outcomes

  1. Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor

    Time frame: Day 1 up to 1 year post-transplant

  2. 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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Korea, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 21, 2016
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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