Chronic Graft-versus-host Disease Clinical Trial
Official title:
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
Verified date | October 2020 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | February 14, 2018 |
Est. primary completion date | February 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Children's Hospital | Seoul | Chongno-gu |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall (complete and partial) response rate | Response evaluation will be performed every 3 months during the treatment by comprehensive response criteria based on NIH criteria. The complete and partial response categories apply only to organs that have measurable and reversible GVHD-related abnormalities at baseline.
Complete response (CR): Resolution of all signs and symptoms of chronic GVHD Partial response (PR) : Improvement (at least 1 clinical score reduction, see Appendix 2) in 1 or more organs of involvement and no evidence of worsening in any organ Objective response (OR): Either CR or PR |
1 year | |
Secondary | Evaluate the safety profile of MMF plus imatinib mesylate | All adverse events will be recorded on the "Adverse Events CRF" with the following information
Severity grade (NCI CTCAE ver. 4.0) Relationship to the study drug Duration (start and end dates or if continuing at final exam) Whether it constitutes a serious adverse event (SAE) |
1 year | |
Secondary | Evaluate the quality of life (QOL) | The assessment of QOL will be performed at baseline and every 3 months till 1 year with Lee cGVHD Symptom Scale. | 1 year | |
Secondary | Discontinuation of steroid | Based on the response during study period, investigators could modify the dosage of concomitant immunosuppressive agents in the same manner as corticosteroid.
The rate of discontinuation among patients and the dose change from baseline of each patient. |
1 year | |
Secondary | Overall survival rate | For survival outcome, Kaplan-Meier method will be used for estimation. | 1 year |
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