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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of subjects in remission for Immunoglobulin G subclass 4 Related Disease at 24 months
. 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
. Known immunodeficiency state
. New York Heart Association Classification III or IV heart disease
. Active malignancy requiring therapy
. Receipt of a live vaccine within 4 weeks prior to initiating study drug therapy.
. Allergies: History of severe allergic reactions to human or chimeric monoclonal antibodies, murine protein, or lenalidomide
. Substance abuse: Drug or alcohol abuse that could interfere with participation in the trial according to the protocol