Graft vs Host DiseasePhase 2/3NCT01788501
Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease
A Phase 2/3 study testing Tacrolimus, Cyclosporine and Methotrexate in people with Graft vs Host Disease, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
This study aims to compare efficacy and safety of tacrolimus/methotrexate with cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic hematopoietic stem cell transplantation patients. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- Tacrolimus, Cyclosporine and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Nov 2011to 1 Mar 2017
- Phase
- Phase 2/3
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of hematological malignancy
- Age under 18 years old
- Serum bilirubin less than 1.5 X upper limit of normal
- Aspartate transaminase, Alanine transaminase less than 2.5 X upper limit of normal
- Alkaline phosphatase less than 2.5 X upper limit of normal
- Serum creatinine less than 1.5 X upper limit of normal
- Agrees to participate, and informed consent signed
Who cannot join
- Evidence of HIV infection
- Documented uncontrolled disease (infections)
- Prior transplantation (hematopoietic stem cell or solid organs)
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease in Paediatric Patients
This study aims to compare efficacy and safety of tacrolimus/methotrexate with cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic hematopoietic stem cell transplantation patients.
- Conditions
- Graft vs Host Disease
- Being tested
- Tacrolimus, Cyclosporine, Methotrexate
- 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.
TacrolimusDrug
D-1~D20: iv infusion, q24hr (first daily dose: 0.03mg/kg) D20~D100: po q12hr (first daily dose: the quadruple of last iv dose) Dose modification according to TDM (10-20ng/ml)
CyclosporineDrug
D-1~D20: iv infusion, q24hr (first daily dose: 3mg/kg) D20~D100: po q12hr (first daily dose: the 3 times of last iv dose) Dose modification according to TDM (200-300ng/ml)
MethotrexateDrug
D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus/Methotrexate | Experimental | Tacrolimus D-1~D20: iv infusion, q24hr (first daily dose: 0.03mg/kg) D20~D100: po q12hr (first daily dose: the quadruple of last iv dose) Dose modification according to therapeutic drug monitoring(TDM) (10-20ng/ml)
Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push Receives: Drug: Tacrolimus; Drug: Methotrexate |
| Cyclosporine/Methotrexate | Active comparator | Cyclosporine D-1~D20: iv infusion, q24hr (first daily dose: 3mg/kg) D20~D100: po q12hr (first daily dose: the 3 times of last iv dose) Dose modification according to TDM (200-300ng/ml)
Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push Receives: Drug: Cyclosporine; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of grade II-IV acute graft versus host disease
Overall grade I graft-versus-host disease denoted stage 1 to 2 skin involvement with no liver or gut involvement. Overall grade II graft-versus-host disease denoted stage 3 skin involvement or stage 1 liver or gut involvement. Overall grade III graft-versus-host disease denoted stage 4 skin involvement or stage 2 to 4 liver or gut involvement without graft-versus-host disease as a major contributing cause of death. And Overall grade IV graft-versus-host disease denoted stage 4 skin involvement or stage 2 to 4 liver or gut involvement with graft-versus-host disease as a major contributing cause of death.
Measured: day 100 post transplantation
Secondary outcomes (2)
incidence of infection
Fever would be categorized as fever occured before engraftment and after engraftment. If microbiologically documented, pathogen would be specified.
Measured: day 100 post transplantation
incidence of adverse drug reactions
adverse drug reactions would be measured by Common Terminology Criteria for Adverse Events v3. And for determinating the likelihood of whether an adverse drug reaction is actually due to the drug, Naranjo algorithm would be used
Measured: day 100 post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startNov 2011
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyoung Jin Kang, Seoul National University Hospital
- Investigators
- JungMi Oh, Pharm.D, Principal investigator, Seoul National University College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788501
- Sponsor's protocol ID
- SNUCP_001
- Status last verified
- Mar 2017
- First submitted
- 25 Nov 2012
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease in Paediatric Patients
- ClinicalTrials.gov ID
- NCT01788501
- Acronym / sponsor ID
- SNUCP_001
- Conditions
- Graft vs Host Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 11 Feb 2013 (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.
This study aims to compare efficacy and safety of tacrolimus/methotrexate with cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic hematopoietic stem cell transplantation patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus/Methotrexate | Experimental | Drug: Tacrolimus, Drug: MethotrexateTacrolimus D-1~D20: iv infusion, q24hr (first daily dose: 0.03mg/kg) D20~D100: po q12hr (first daily dose: the quadruple of last iv dose) Dose modification according to therapeutic drug monitoring(TDM) (10-20ng/ml) Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push |
| Cyclosporine/Methotrexate | Active comparator | Drug: Cyclosporine, Drug: MethotrexateCyclosporine D-1~D20: iv infusion, q24hr (first daily dose: 3mg/kg) D20~D100: po q12hr (first daily dose: the 3 times of last iv dose) Dose modification according to TDM (200-300ng/ml) Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosis of hematological malignancy
- Age under 18 years old
- Serum bilirubin less than 1.5 X upper limit of normal
- Aspartate transaminase, Alanine transaminase less than 2.5 X upper limit of normal
- Alkaline phosphatase less than 2.5 X upper limit of normal
Key exclusion criteria (3 listed)
- Evidence of HIV infection
- Documented uncontrolled disease (infections)
- Prior transplantation (hematopoietic stem cell or solid organs)
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 |
|---|---|---|
| TacrolimusD-1~D20: iv infusion, q24hr (first daily dose: 0.03mg/kg) D20~D100: po q12hr (first daily dose: the quadruple of last iv dose) Dose modification according to TDM (10-20ng/ml) | Drug | Tacrolimus/Methotrexate |
| CyclosporineD-1~D20: iv infusion, q24hr (first daily dose: 3mg/kg) D20~D100: po q12hr (first daily dose: the 3 times of last iv dose) Dose modification according to TDM (200-300ng/ml) | Drug | Cyclosporine/Methotrexate |
| MethotrexateD1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push | Drug | Cyclosporine/Methotrexate, Tacrolimus/Methotrexate |
Primary outcome
incidence of grade II-IV acute graft versus host disease
Time frame: day 100 post transplantation
Overall grade I graft-versus-host disease denoted stage 1 to 2 skin involvement with no liver or gut involvement. Overall grade II graft-versus-host disease denoted stage 3 skin involvement or stage 1 liver or gut involvement. Overall grade III graft-versus-host disease denoted stage 4 skin involvement or stage 2 to 4 liver or gut involvement without graft-versus-host disease as a major contributing cause of death. And Overall grade IV graft-versus-host disease denoted stage 4 skin involvement or stage 2 to 4 liver or gut involvement with graft-versus-host disease as a major contributing cause of death.
2 secondary outcomes
incidence of infection
Time frame: day 100 post transplantation
incidence of adverse drug reactions
Time frame: day 100 post transplantation
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 22 Mar 2017.
- Individual participant dataSharing planned: No
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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.
JungMi Oh, Pharm.D principal investigator
Seoul National University College of Pharmacy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tacrolimus, Cyclosporine and Methotrexate in people with Graft vs Host Disease, run by Seoul National University Hospital 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 7 inclusion and 3 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 22 Mar 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
incidence of grade II-IV acute graft versus host disease (time frame: day 100 post transplantation). 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 22 Mar 2017.