Status:
TERMINATED
Imatinib Mesylate and Mycophenolate Mofetil for Steroid-Refractory Sclerotic/Fibrotic cGVHD in Children
Lead Sponsor:
Seoul National University Hospital
Conditions:
Chronic Graft-versus-host Disease
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief 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 f...
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01898377
Start Date
August 1 2013
End Date
February 14 2018
Last Update
October 23 2020
Active Locations (1)
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1
Seoul National University Children's Hospital
Seoul, Chongno-gu, South Korea