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A Phase II Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease

We hypothesize the addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, and enable a more rapid and effective steroid taper.

Stanford is not currently accepting new patients for this trial. You may want to check to see if other locations are recruiting.



  • drug : Rituximab
  • drug : tacrolimus
  • drug : cyclosporine A
  • drug : Prednisone

Phase: N/A


Ages Eligible For Study:

1 Year - 75 Years

Inclusion Criteria

Both children and adults with a new diagnosis of chronic GVHD, must include skin involvement, with indication for systemic immunosuppressive treatment to a dose of 1mg/kg prednisone who has undergone any type of donor hematopoietic cell graft or conditioning regimen. See Appendix for NIH Consensus Signs and symptoms Chronic GVHD. The NIH cGVHD Working group recommendation for Diagnosis of chronic GVHD requires a diagnostic sign or at least 1 distinctive manifestation of cGVHD with the diagnosis confirmed by pertinent biopsy or radiology confirmation or Schirmer's test. The guideline for indication to start systemic steroids is as follows: - 2 or more organs involved (must include skin) with organ score e 2 (see Appendix for organ scoring) - Stable doses of other immunosuppressive medications (e.g. calcineurin inhibitors, mycophenolate mofetil) for 2 weeks prior to enrollment. In addition, these other immunosuppressive medications should not be dose increased. - Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. - All subjects must provide written informed consent.

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Contact information

Primary Contact:

BMT Referrals 6507230822

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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