Overview

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

Status:
Terminated
Trial end date:
2018-02-14
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Treatments:
Imatinib Mesylate
Mycophenolate mofetil
Mycophenolic Acid
Criteria
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