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Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease

Primary Purpose

Graft vs Host Disease

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tacrolimus
Cyclosporine
Methotrexate
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft vs Host Disease

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tacrolimus/Methotrexate

Cyclosporine/Methotrexate

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

incidence of infection
Fever would be categorized as fever occured before engraftment and after engraftment. If microbiologically documented, pathogen would be specified.
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

Full Information

First Posted
November 25, 2012
Last Updated
March 20, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01788501
Brief Title
Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease
Official Title
Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease in Paediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus/Methotrexate
Arm Type
Experimental
Arm Description
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
Arm Title
Cyclosporine/Methotrexate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push
Primary Outcome Measure Information:
Title
incidence of grade II-IV acute graft versus host disease
Description
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.
Time Frame
day 100 post transplantation
Secondary Outcome Measure Information:
Title
incidence of infection
Description
Fever would be categorized as fever occured before engraftment and after engraftment. If microbiologically documented, pathogen would be specified.
Time Frame
day 100 post transplantation
Title
incidence of adverse drug reactions
Description
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
Time Frame
day 100 post transplantation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Evidence of HIV infection Documented uncontrolled disease (infections) Prior transplantation (hematopoietic stem cell or solid organs)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JungMi Oh, Pharm.D
Organizational Affiliation
Seoul National University College of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease

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