WithdrawnPhase 2ACTRN12606000326594

Prospective study of Rituximab for chronic graft vs host disease (GVHD) sub-optimally responsive to immunosuppressive therapy: Assessment of response.

Sponsor

Australasian Leukaemia and Lymphoma Group

Enrollment

20 participants

Start Date

Sep 1, 2006

Study Type

Interventional

Conditions

Chronic graft versus host disease post allogeneic bone marrow transplant

Summary

Chronic graft vs host disease (cGVHD) can affect a number of target organs following bone marrow transplantation. In such cases, numerous combinations of immunosuppressive drugs are used to try and control the cGVHD. Often these drugs are not particularly successful yet patients may need to remain on quite intensive immunosuppressant therapy in the long term. The aim of this study is to see whether the drug rituximab (also called mabthera) is effective in improving cGVHD in these patients so that the dose of immunosuppressant drugs can be reduced. Rituximab reduces the number of a type of white cell called B lymphocytes which may be over active in patients with cGVHD. Small studies overseas have shown that some patients with GVHD have responded very well to rituximab. This study is designed to treat a larger number of patients so we can more clearly define the value of this treatment.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether the drug rituximab can help people aged 18 and over who have severe chronic graft-versus-host disease (a complication after a bone marrow transplant where donated cells attack the body) that has not responded well to standard immune-suppressing treatments.

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

All patients will receive one course of Rituximab induction therapy, consisting of four intravenous infusions of Rituximab, each of them one week apart. Further clinical trial procedures depend on the response of the cGVHD at 3 months after completion of Rituximab induction therapy. For patients who are eligible to remain in the study these further trial procedures may consist of a follow-up period without further Rituximab administration or Rituximab reinduction therapy (comparable to the induction therapy), possibly (depending on the response of cGVHD) followed by a Rituximab maintenance therapy consisting of four intravenous infusions of Rituximab, each of them 3 months apart. Total follow up will be up to a maximum of 3.5 years.

Locations(1)

VIC, Australia

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ACTRN12606000326594