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

Graft vs Host Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Graft vs Host Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug: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: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:MethotrexateD1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Tacrolimus/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/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

Study Status

Completed

Start Date: November 2011

Completed Date: March 1, 2017

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: incidence of grade II-IV acute graft versus host disease

Secondary Outcome: incidence of infection

Study sponsors, principal investigator, and references

Principal Investigator: JungMi Oh, Pharm.D

Lead Sponsor: Seoul National University Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01788501

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