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

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment — a single dose of the drug rituximab plus a low dose of radiation to the lymph nodes (total nodal irradiation) — for people who have developed a serious complication called chronic graft-versus-host disease (cGVHD) after a bone marrow transplant. cGVHD happens when the donor immune cells attack the recipient's body, particularly the skin and other organs. Standard steroid-based treatments don't always work well, and this study is exploring whether this combination approach is safe and effective. You may be eligible if: - You have had a bone marrow (allogeneic stem cell) transplant - You have active, extensive skin involvement from chronic graft-versus-host disease - Your condition has not responded adequately to standard immune-suppressing medications You may NOT be eligible if: - You have permanent, irreversible organ damage from cGVHD - You have an uncontrolled active infection - You have severely low blood counts (severe cytopenias) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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