RecruitingPhase 2ACTRN12607000628448

A pilot study of combining rituximab and low-dose (1.0Gy) total nodal irradiation in treatment of extensive chronic graft-versus-host disease


Sponsor

Simon He and Andrew Grigg

Enrollment

20 participants

Start Date

Nov 1, 2008

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and females

Inclusion Criteria1

  • active, extensive cutaneous chronic GVHD with suboptimal response to standard systemic immunosuppression

Exclusion Criteria2

  • (1) Chronic GVHD with irreversible end-organ damage (2) uncontrolled infection (3)
  • Severe cytopenias

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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 re

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


Locations(1)

Australia

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ACTRN12607000628448