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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01788501
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Hyoung Jin Kang, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Drug: Tacrolimus Drug: Cyclosporine Drug: Methotrexate Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease in Paediatric Patients
Actual Study Start Date : November 2011
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tacrolimus/Methotrexate

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: 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)

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

Active Comparator: Cyclosporine/Methotrexate

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: 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)

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. incidence of infection [ Time Frame: day 100 post transplantation ]
    Fever would be categorized as fever occured before engraftment and after engraftment. If microbiologically documented, pathogen would be specified.

  2. incidence of adverse drug reactions [ Time Frame: day 100 post transplantation ]
    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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788501


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: JungMi Oh, Pharm.D Seoul National University College of Pharmacy

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Responsible Party: Hyoung Jin Kang, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01788501    
Other Study ID Numbers: SNUCP_001
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Cyclosporine
Methotrexate
Tacrolimus
Cyclosporins
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Calcineurin Inhibitors
Antifungal Agents
Anti-Infective Agents