NCT01788501

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

5.3 years

First QC Date

November 25, 2012

Last Update Submit

March 20, 2017

Conditions

Graft vs Host Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    day 100 post transplantation

Secondary Outcomes (2)

  • incidence of infection

    day 100 post transplantation

  • incidence of adverse drug reactions

    day 100 post transplantation

Study Arms (2)

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

Drug: TacrolimusDrug: 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

Drug: CyclosporineDrug: Methotrexate

Interventions

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)

Tacrolimus/Methotrexate
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)

Cyclosporine/Methotrexate
MethotrexateDRUG

D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push

Cyclosporine/MethotrexateTacrolimus/Methotrexate

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Evidence of HIV infection
  • Documented uncontrolled disease (infections)
  • Prior transplantation (hematopoietic stem cell or solid organs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

TacrolimusCyclosporineMethotrexate

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • JungMi Oh, Pharm.D

    Seoul National University College of Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 25, 2012

First Posted

February 11, 2013

Study Start

November 1, 2011

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(3)