A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
Trial ID or NCT#
Status
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
Eligibility 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.
- * 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.
Investigator(s)
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Contact
BMT Referrals
6507230822
View on ClinicalTrials.gov