A pilot study of combining rituximab and low-dose (1.0Gy) total nodal irradiation in treatment of extensive chronic graft-versus-host disease
Phase 2
Recruiting
- Conditions
- Chronic graft-versus-host disease (GVHD)Blood - Haematological diseases
- Registration Number
- ACTRN12607000628448
- Lead Sponsor
- Simon He and Andrew Grigg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
active, extensive cutaneous chronic GVHD with suboptimal response to standard systemic immunosuppression
Exclusion Criteria
(1) Chronic GVHD with irreversible end-organ damage (2) uncontrolled infection (3)
Severe cytopenias
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety and tolerability: measured by clinical assessment ( evidence of infection); full blood examination (cytopenias); biochemistry and liver enzyme tests (for organ toxicity); reactivation of cytomegalovirus (CMV) by serial CMV antigen by PCR testing in first 2 months[at 3 months after single dose of 1000mg of rituximab and single dose of 1.0Gy of total nodal irradiation]
- Secondary Outcome Measures
Name Time Method response rate: measured by (1) total dose reduction in systemic immunosuppression (for example: complete remission if off all immunosuppression by 3 months); (2)detail clinical examination; (3) repeat skin biopsy for histological assessment;[at 3, 6, 12, 24 months]