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

Graft vs Host Disease Clinical Trial

Official title:

Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease in Paediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788501
• Other study ID #: SNUCP_001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 25, 2012
• Last updated: March 20, 2017
• Start date: November 2011
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Graft vs Host Disease

Intervention

Drug:
• 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 TDM (10-20ng/ml)
• 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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	incidence of infection	Fever would be categorized as fever occured before engraftment and after engraftment. If microbiologically documented, pathogen would be specified.	day 100 post transplantation
Secondary	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	day 100 post transplantation