None listed
Conditions
Interventions
Drug : 1. We will conduct a prospective clinical trial in patients with above moderate score cGVHD in response to allogeneic stem cell transplantation according to the National Health Institute (NIH)
Biosimilar compound of Rituximab at 300 mg fixed dose/week, 4 times and 300 mg every 3 months, 4 times) and prednisolone and check for treatment efficacy and side effects.
2. In patients who exhibit c
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) cGVHD patients who were newly diagnosed with above moderate levels of cGVHD by NIH criteria a. Distinction from acute GVHD b. Presence of at least 1 diagnostic clinical sign of chronic GVHD or presence of at least 1 distinctive manifestation confirmed by pertinent biopsy or other relevant tests c. Exclusion of other possible diagnosis 2) Age >16 years 3) ECOG (Eastern Cooperative Oncology Group) 0-2 4) Patients expected to comply with the clinical protocol at the judgment of the investigator 5) Patients understand the content of the research and voluntarily consent to it in writing
Exclusion criteria
Exclusion criteria: 1) Progression of underlying disease 2) Uncontrolled ischemia and heart failure, arrhythmia requiring medication. 3) Cardiac ejection fraction < Normal 4) Active hepatitis and HIV Infection 5) Other malignancy disease except underlying disease 6) Hypersensitivity to Rituximab 7) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tratment response of cGVHD according to NIH(National Institutes of Health) criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| B-cell and T-cell marker (CD19, CD38, CD27, IgD, CD3, LAG3, Tim3, TIGIT, PD-1,etc.) | — |
Countries
Korea, Republic of
Contacts
Public ContactEunjin Lee
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed