Graft Versus Host DiseasePhase 4NCT02660684
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
A Phase 4 study testing Prograf, Methotrexate and Cyclosporine in people with Graft Versus Host Disease, run by Astellas Pharma Korea, Inc. at 3 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- Prograf, Methotrexate and Cyclosporine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Feb 2008to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- MDS (myelodysplastic syndrome)
- Myeloma (multiple myeloma)
- A patient who received peripheral hematopoietic stem cell transplantation from a HLA-matched sibling donor
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Study site
Daegu, Gyeongsangnam-do
Study site
Hwasun-gun, Jeonranam-do
Study site
Seoul
About this study
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
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
- Being tested
- Prograf, Methotrexate, Cyclosporine
- Keywords
- Prograf, Graft versus host disease, Hematopoietic stem cell transplantation, Prophylaxis, Peripheral hematopoietic stem cell transplantation
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrografDrug
Also called Tacrolimus
Injection or oral
MethotrexateDrug
Injection
CyclosporineDrug
Injection or oral
| Study group | Role | What they receive |
|---|---|---|
| Prograf + MTX | Experimental | Not described Receives: Drug: Prograf; Drug: Methotrexate |
| Cyclosporine + MTX (historical control) | Active comparator | Not described Receives: Drug: Methotrexate; Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of occurrence sites of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
Measured: 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.
Measured: 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
Measured: 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).
Measured: Day 100 up to 1 year post-transplant
Safety as assessed by adverse events
Measured: Day 1 up to 1 year post-transplant
Safety as assessed by laboratory assessments
Includes hematology, biochemistry and trough plasma concentration analysis
Measured: 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
Measured: 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
Measured: Day 1 up to 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Korea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660684
- Sponsor's protocol ID
- PRG-07-11-KOR
- Status last verified
- Feb 2016
- First submitted
- 18 Jan 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02660684
- Acronym / sponsor ID
- PRG-07-11-KOR
- Conditions
- Graft Versus Host Disease
- Keywords
- Prograf, Graft versus host disease, Hematopoietic stem cell transplantation, Prophylaxis, Peripheral hematopoietic stem cell transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prograf + MTX | Experimental | Drug: Prograf, Drug: Methotrexate |
| Cyclosporine + MTX (historical control) | Active comparator | Drug: Methotrexate, Drug: Cyclosporine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Blood diseases for a standard risk group
- A patient who received peripheral hematopoietic stem cell transplantation from a HLA-matched sibling donor
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrografAlso: TacrolimusInjection or oral | Drug | Prograf + MTX |
| MethotrexateInjection | Drug | Cyclosporine + MTX (historical control), Prograf + MTX |
| CyclosporineInjection or oral | Drug | Cyclosporine + MTX (historical control) |
Primary outcome
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
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.
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
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).
Safety as assessed by adverse events
Time frame: 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
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Individual participant dataSharing planned: Undecided
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Korea, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prograf, Methotrexate and Cyclosporine in people with Graft Versus Host Disease, run by Astellas Pharma Korea, Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.