A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease

Not Recruiting

Trial ID: NCT00350545

Purpose

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

Official Title

A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease

Stanford Investigator(s)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


Inclusion Criteria:

   - Children and adults with a new diagnosis of chronic GVHD- that requires systemic
   immunosuppressive treatment to a dose of 1mg/kg/day prednisone and who have undergone
   any type of donor hematopoietic cell graft or conditioning regimen.

   - 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.

Exclusion Criteria:

   - Known life-threatening hypersensitivity to Rituximab or other anti-B cell antibody.

   - Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time
   of enrollment. Persistent prednisone treatment of acute GVHD that is less than 1mg/kg
   is allowed.

   - Active, uncontrolled infection- CMV reactivation is excluded (i.e. pneumonitis,
   colitis). Peripheral blood CMV reactivation is allowed as long as it is not associated
   with CMV disease and is responding to therapy.

   - Known Hepatitis B surface Ag positive

   - Active malignant disease relapse.

   - Pregnancy

   - Lactating

   - Inability to comply with the Rituximab treatment regimen.

Intervention(s):

drug: Rituximab

drug: Prednisone

drug: cyclosporine A

drug: tacrolimus

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822

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