Treatment of IgG4-Related Disease With Revlimid and Rituximab

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT02705638
Phase
PHASE1
Status
Completed

Conditions

  • Autoimmune Pancreatitis
  • IgG4-related Disease
  • IgG4-related Sclerosing Cholangitis
  • Immunoglobulin G Subclass 4 Related Disease
  • Retroperitoneal Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    All subjects will receive Rituxan 1,000 mg intravenously on days 1 and 15.
  • Lenalidomide — DRUG
    All subjects will receive Revlimid 20 mg orally per day on days 1-21, 29-49, and 57-77.

Study Details

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?

Key Dates

Start date
Apr 30, 2016
Status verified
Jul 2019
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab and Lenalidomide
    All subjects will receive Rituxan 1,000 mg intravenously on days 1 and 15, as well as Revlimid 20 mg orally per day on days 1-21, 29-49, and 57-77.

Primary Outcome Measure

Number of subjects in remission for Immunoglobulin G subclass 4 Related Disease at 24 months [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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By research site
Mayo Clinic in Rochester· Rochester, MN

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