Treatment of IgG4-Related Disease With Revlimid and Rituximab (NCT02705638) | Clinical Trial Compass
CompletedPhase 1
Treatment of IgG4-Related Disease With Revlimid and Rituximab
United States6 participantsStarted 2016-04
Plain-language summary
Among persons with Immunoglobulin G subclass 4 Related Disease (IgG4)-related disease who have persistent or recurrent disease despite standard therapies, does combination therapy with rituximab and revlimid cause a sustained disease remission?
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of active IgG4-RD based on standard pathologic or clinical criteria (see below) and requiring medical treatment
✓. Patient is:
✓. in relapse after prior steroid and/or rituximab (RTX) treatment or while tapering steroid treatment, OR
✓. has disease that is refractory to steroids, OR
✓. has contraindications to steroid therapy (including diabetes, mood disorder, obesity)
✓. Absolute neutrophil count \>1500 and platelet count \>/= 100,000
✓. Calculated creatinine clearance (or estimated GFR) greater than or equal to 60ml/min
✓. In patients without hepatobiliary involvement by IgG4-RD, total bilirubin less than or equal to 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) less than or equal to 3 x ULN
Exclusion criteria
✕. Predominant changes of fibrosis (as opposed to active cellular inflammation) within the organs affected by IgG4-RD, such that the likelihood of a disease response to treatment is low
✕. Presence of active infection that would interfere with therapy on this study, including positive serum hepatitis B surface antigen, HIV or active hepatitis C virus (HCV) infection, untreated syphilis or tuberculosis, clinical history of multiple herpes virus reactivations
✕
What they're measuring
1
Number of subjects in remission for Immunoglobulin G subclass 4 Related Disease at 24 months