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

Astellas Pharma Korea, Inc.39 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Graft Versus Host Disease

Interventions

PrografDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Daegu, Gyeongsangnam-do, South Korea

Unnamed facility

Hwasun-gun, Jeonranam-do, South Korea

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

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

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.

Time frame: 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

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).

Time frame: Day 100 up to 1 year post-transplant

Safety as assessed by adverse events

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

Safety as assessed by laboratory assessments

Includes hematology, biochemistry and trough plasma concentration analysis

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

Secondary Outcomes

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

Time frame: 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