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

NCT02660684 | Completed Phase 4

• 1 other identifier: PRG-07-11-KOR
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

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.

Conditions

Graft Versus Host Disease

Keywords

Prograf; Graft versus host disease; Hematopoietic stem cell transplantation; Prophylaxis; Peripheral hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (6)

• Number of occurrence sites of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor

  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.

  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

  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).

  Day 100 up to 1 year post-transplant

• Safety as assessed by adverse events

  Day 1 up to 1 year post-transplant

• Safety as assessed by laboratory assessments

  Includes hematology, biochemistry and trough plasma concentration analysis

  Day 1 up to 1 year post-transplant

Secondary Outcomes (2)

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

  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

  Day 1 up to 1 year post-transplant

Study Arms (2)

Prograf + MTX

EXPERIMENTAL

Drug: Prograf; Drug: Methotrexate

Cyclosporine + MTX (historical control)

ACTIVE COMPARATOR

Drug: Methotrexate; Drug: Cyclosporine

Interventions

Prograf DRUG

Injection or oral

Also known as: Tacrolimus

Prograf + MTX

Methotrexate DRUG

Injection

Cyclosporine + MTX (historical control); Prograf + MTX

Cyclosporine DRUG

Injection or oral

Cyclosporine + MTX (historical control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (3)

Unknown Facility

Daegu, Gyeongsangnam-do, South Korea

Location

Unknown Facility

Hwasun-gun, Jeonranam-do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related Links

• Link to results on Astellas Clinical Study Results Web site

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Tacrolimus; Methotrexate; Cyclosporine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Director

  Astellas Pharma Korea, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 21, 2016
• Study Start: February 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

KR (3)