A Phase 2 , single center, Safety and efficacy of rituximab biosimilar(Truxima®)-based first line treatment of chronic graft-versus-host disease
- Conditions
- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 38
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tratment response of cGVHD according to NIH(National Institutes of Health) criteria
- Secondary Outcome Measures
Name Time Method B-cell and T-cell marker (CD19, CD38, CD27, IgD, CD3, LAG3, Tim3, TIGIT, PD-1,etc.)