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