Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Graft Versus Host Disease
Keywords: Prograf
Graft versus host disease
Hematopoietic stem cell transplantation
Prophylaxis
Peripheral hematopoietic stem cell transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-01-21
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of occurrence sites of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
timeFrame: Day 1 up to Day 100 post-transplant
measure: Severity of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
timeFrame: Day 1 up to Day 100 post-transplant
measure: Number of occurrence sites of chronic GVHD occurring after 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
timeFrame: Day 100 up to 1 year post-transplant
measure: Classification of chronic GVHD occurring after 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
timeFrame: Day 100 up to 1 year post-transplant
measure: Safety as assessed by adverse events
timeFrame: Day 1 up to 1 year post-transplant
measure: Safety as assessed by laboratory assessments
timeFrame: Day 1 up to 1 year post-transplant
Secondary outcomes:
measure: Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor
timeFrame: Day 1 up to 1 year post-transplant
measure: Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor in comparison with Cyclosporine in combination with MTX
timeFrame: Day 1 up to 1 year post-transplant
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
state: Gyeongsangnam-do
city: Hwasun-gun
country: Korea, Republic of
state: Jeonranam-do
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Korea, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: