Treatment of IgG4-Related Disease With Revlimid and Rituximab

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

First listed

Mar 10, 2016

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)

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