A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
Completed · Not applicable
Conditions studied: Graft vs Host Disease
In brief
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.
Key facts
- Study ID
- NCT00350545
- Run by
- Stanford University
- People needed
- 37
- Starts
- 2006-08-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2017-11-20
Who can join
Age: 1 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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