Open-label, multicenter phase II study of imatinib mesylate in patients with steroid-refractory chronic graft-versus-host disease
Not Applicable
Completed
- Conditions
- Neoplasms
- Registration Number
- KCT0006785
- Lead Sponsor
- Kyungpook National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
i) age = 20 years,
ii) Eastern Cooperative Oncology Group performance status score = 2,
iii) Chronic graft-versus host disease that meets the NIH diagnostic criteria after allogeneic-SCT,
iv) moderate or severe cGVHD based on the NIH global scoring system,
v) steroid-refractory cGVHD,
vi) resistance to calcineurin inhibitors such as cyclosporine and tacrolimus
Exclusion Criteria
1. Hepatic chronic graft-versus host disease alone
2. Patients who had donor lymphocyte infusion
3. Poor general condition
4. ECOG > 3
5. Other investigational agent treatment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event free survival
- Secondary Outcome Measures
Name Time Method Overall survival