None listed
Conditions
Brief summary
Chronic graft-versus-host disease (cGVHD) is a significant complication for many patients who survive an allogeneic bone marrow transplantation for haematological maligancy. A number of patients with extensive cGVHD have suboptimal control despite adequate steroid-based therapy with other immunosuppression such as cyclosporin. There is no standard salvage treatment to effectively control the disease and avoid long-term toxicity of steroids. This is the first prospective pilot study to explore the use of a single-dose of rituximab plus Low-dose total nodal irradiation (TNI) in the treatment of cGVHD involving the skin and other organ(s). There are a growing body of retrospective data regarding the effectiveness of rituximab and TNI respectively for the treatment of cGVHD. The hypothesis in this pilot study is that the combined treatment approach is safe and effective in treating extensive cGVHD.
Interventions
Single dose of 1000mg iv Rituximab (given on Day 1) combined with low-dose (1.0 Gy) total nodal irradiation (given only on Day 8). GVHD assessment at 3 months: if chronic GVHD improves, proceed to receive maintenance rituximab (500mg iv) 3 monthly x 4
Sponsors
Simon He and Andrew Grigg
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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
Outcome results
None listed