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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

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ClinicalTrials.gov Identifier: NCT02660684
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

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.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Drug: Prograf Drug: Methotrexate Drug: Cyclosporine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prograf + MTX Drug: Prograf
Injection or oral
Other Name: Tacrolimus

Drug: Methotrexate
Injection

Active Comparator: Cyclosporine + MTX (historical control) Drug: Methotrexate
Injection

Drug: Cyclosporine
Injection or oral




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660684


Locations
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Korea, Republic of
Daegu, Gyeongsangnam-do, Korea, Republic of
Hwasun-gun, Jeonranam-do, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
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Study Director: Medical Director Astellas Pharma Korea, Inc.

Additional Information:
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Responsible Party: Astellas Pharma Korea, Inc.
ClinicalTrials.gov Identifier: NCT02660684    
Other Study ID Numbers: PRG-07-11-KOR
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):
Prograf
Graft versus host disease
Hematopoietic stem cell transplantation
Prophylaxis
Peripheral hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Cyclosporine
Methotrexate
Tacrolimus
Cyclosporins
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Calcineurin Inhibitors
Antifungal Agents
Anti-Infective Agents