- ICH GCP
- US Clinical Trials Registry
- 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
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
Status
Completed
Conditions
Intervention / Treatment
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:
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Graft vs Host Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Calcineurin Inhibitors
- Methotrexate
- Tacrolimus
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- PRG-07-11-KOR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
Clinical Trials on Graft Versus Host Disease
-
University of LiegeTerminatedChronic Graft-Versus-Host Disease | Acute Graft-Versus-Host Disease | Steroid Refractory Graft-Versus-Host DiseaseBelgium
-
Jazz PharmaceuticalsCompletedAcute-graft-versus-host Disease | Graft-versus-host DiseaseUnited States, Belgium, United Kingdom, Greece, Germany, Spain, France, Italy, Austria, Canada, Bulgaria, Croatia, Poland, Portugal
-
Mesoblast, Inc.Quintiles, Inc.CompletedGrade B Acute Graft Versus Host Disease | Grade C Acute Graft Versus Host Disease | Grade D Acute Graft Versus Host DiseaseUnited States
-
Grupo Espanol de trasplantes hematopoyeticos y...CompletedChronic Graft-Versus-Host DiseaseSpain
-
National Cancer Institute (NCI)TerminatedGraft vs Host Disease | Graft-Versus-Host Disease | Chronic Graft vs. Host DiseaseUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNovartisCompletedGraft-Versus-Host DiseaseUnited States
-
M.D. Anderson Cancer CenterCompleted
-
Fundación Pública Andaluza para la gestión de la...Instituto de Salud Carlos IIIActive, not recruitingGraft-versus-host DiseaseSpain
-
National Heart, Lung, and Blood Institute (NHLBI)TerminatedGraft-Versus-Host DiseaseUnited States
-
MallinckrodtCompletedGraft-versus-Host DiseaseUnited States, Australia, France, Italy, Austria, Germany, Portugal, Slovakia, Spain, Switzerland, Turkey, United Kingdom
Clinical Trials on Prograf
-
University Medicine GreifswaldCompletedHypercholesterolemia | Pharmacokinetics | Immunosuppression | Drug InteractionsGermany
-
National Taiwan University HospitalAstellas Pharma Taiwan, Inc.UnknownAdherence to Medication RegimeTaiwan
-
Veloxis PharmaceuticalsCompleted
-
National Institute of Allergy and Infectious Diseases...Completed
-
Astellas Pharma IncCompleted
-
Veloxis PharmaceuticalsCompleted
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCzechia, France, Italy, Poland, United Kingdom
-
University of British ColumbiaSimon Fraser University; Astellas Pharma Canada, Inc.CompletedRenal Transplant | Renal DiseaseCanada
-
HK inno.N CorporationNot yet recruitingHealthyKorea, Republic of
-
Astellas Pharma Europe Ltd.Active, not recruitingLiver Transplantation | Kidney Transplantation | Heart Transplantation | Lung Transplantation | Intestine TransplantationBelgium, Czechia, France, Germany, Italy, Poland, United Kingdom