Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease

Completed · Phase 1/Phase 2

Conditions studied: Graft vs Host Disease

In brief

The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).

Key facts

Study ID: NCT00136396
Run by: Dana-Farber Cancer Institute
People needed: 30
Starts: 2004-01-01
Expected to finish: 2010-11-01
Last updated by the study team: 2013-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Recipients of matched related, matched unrelated, or mismatched stem cell transplantation
At least 180 days since allogeneic stem cell transplantation procedure
Patients must have steroid-refractory chronic GVHD, defined as having persistent signs and symptoms despite the use of prednisone
Stable dose of corticosteroids for 4 weeks prior to enrollment
Adequate bone marrow function: absolute neutrophil count (ANC) > 500/mm; platelets > 20,000 ul
Adequate renal function: creatinine < 3.0 mg/dl
Adequate hepatic function: bilirubin < 3.0 mg/dl; AST < 90 IU

You may not qualify if…

Prednisone requirement greater than 2 mg/kg/day or equivalent
Known life-threatening sensitivity to rituximab or other anti-B cell antibody.
Prior exposure to any new immunosuppressive medication in the preceding 4 weeks prior to enrollment.
Active, uncontrolled infection
Evidence of natural exposure to hepatitis B or C.
Active malignant disease relapse
Donor lymphocyte infusion within the preceding 100 days.
Life expectancy of less than 3 months.
Pregnancy or lactation
Evidence of HIV seropositivity

Where it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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