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Imatinib Mesylate and Mycophenolate Mofetil for Steroid-Refractory Sclerotic/Fibrotic cGVHD in Children | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Imatinib Mesylate and Mycophenolate Mofetil for Steroid-Refractory Sclerotic/Fibrotic cGVHD in Children

Open-label, Multicenter Phase II Study of Combination Therapy of Imatinib Mesylate and Mycophenolate Mofetil in Children With Steroid-Refractory Sclerotic/Fibrotic Type Chronic Graft-versus-host Disease

NCT01898377•Seoul National University Hospital

View on ClinicalTrials.gov

Summary

In this study we will combine mycophenolate mofetil and imatinib mesylate to treat steroid-refractory sclerotic/fibrotic type chronic graft-versus-host disease (GVHD) to see the response rate and to find the safety of combination.

Detailed Description

Sclerotic/fibrotic type chronic GVHD is one of the most severe forms of the disease and is frequently refractory to standard treatment approaches. Imatinib mesylate, a tyrosine kinase inhibitor, has been shown to be effective in patients with sclerotic/fibrotic type chronic GVHD by strongly inhibiting both PDGF (Platelet-derived growth factor) and TGF-β (transforming growth factor-β) intracellular signaling, which is responsible for the expression of extracellular matrix genes. Mycophenolate mofetil (MMF) is one of effective agent for the treatment of chronic graft-versus-host disease. MMF is rapidly absorbed after oral administration and hydrolyzed to the active metabolite, MPA (mycophenolic acid). MPA selectively inhibits inosine monophosphate dehydrogenase, blocking the pathway of purine synthesis in T and B lymphocytes. In this study we will combine MMF and imatinib mesylate to treat steroid-refractory sclerotic/fibrotic type chronic GVHD to see the response rate and to find the safety of combination.

Eligibility

Age

0 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a diagnosis of chronic GVHD with fibrotic/scleroderma-like features. This diagnosis can be made clinically or by histopathology.
•Patients must have active disease with at least one of the following manifestations: skin sclerosis, symptomatic bronchiolitis obliterans, extensive lung fibrosis, pathologically demonstrated visceral fibrotic involvement of the gut.
•Patients with corticosteroid refractory or dependant cGVHD are eligible. Steroid-refractory chronic GVHD is defined as chronic GVHD of sustained severity during the last full month during which the patients received the equivalent of prednisone 0.5 mg/kg or more per day or 1 mg/kg or more every other day.
•Age under 21 years old

Exclusion Criteria

•Patients who have had chemotherapy, radiotherapy within 4 weeks prior to entering the study.
•Patients who have not recovered from adverse events.
•Prior treatment with imatinib mesylate or other tyrosine kinase inhibitor after the date of transplant.
•Patients on pregnancy or lactating

Locations (1)

Seoul National University Children's Hospital

Seoul, Chongno-gu, South Korea

Key Dates

Start Date

August 1, 2013

Primary Completion Date

February 14, 2018

Completion Date

February 14, 2018

Last Updated

October 23, 2020

Enrollment

ACTUAL participants

Conditions

Chronic Graft-versus-host Disease

Interventions

Imatinib mesylate, Mycophenolate mofetil

DRUG

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

NCT06660355

Chronic Graft-versus-host Disease (cGVHD)

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ACTIVE_NOT_RECRUITING

Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

NCT02611180

Acute Graft-versus-host DiseaseAcute GVHD+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Imatinib Mesylate and Mycophenolate Mofetil for Steroid-Refractory Sclerotic/Fibrotic cGVHD in Children

Inclusion Criteria

Exclusion Criteria

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

A Prospective Observational Study for Evaluating CGVHD

Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD