Open-label, multicenter phase II study of imatinib mesylate in patients with steroid-refractory chronic graft-versus-host disease

Open-label, multicenter phase II study of imatinib mesylate (Leukivec®) in patients with steroid-refractory chronic graft-versus-host disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006785

Enrollment

Registered

2021-11-26

Start date

2014-03-17

Completion date

Unknown

Last updated

2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Enrolled patients received 100 mg/day imatinib for two weeks. The imatinib dose was allowed to increase by 100 mg every two weeks up to 400 mg/day depending on the patient’s condition and the i

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Event free survival	—

Secondary

Measure	Time frame
Overall survival	—

Countries

Korea, Republic of

Contacts

Public ContactDong Won Baek

Kyungpook National University Hospital

vroom21@hanmail.net+82-53-200-5568

Outcome results