Treatment of IgG4-Related Disease With Revlimid and Rituximab

NCT02705638 | Completed Phase 1

• 1 other identifier: 15-003700
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of subjects in remission for Immunoglobulin G subclass 4 Related Disease at 24 months

  24 months

Study Arms (1)

Rituximab and Lenalidomide

EXPERIMENTAL

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.

Drug: Rituximab; Drug: Lenalidomide

Interventions

Rituximab DRUG

All subjects will receive Rituxan 1,000 mg intravenously on days 1 and 15.

Also known as: Rituxan

Rituximab and Lenalidomide

Lenalidomide DRUG

All subjects will receive Revlimid 20 mg orally per day on days 1-21, 29-49, and 57-77.

Also known as: Revlimid

Rituximab and Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Not pregnant or nursing
• All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS™) program, and be willing and able to comply with the requirements of the REMS™ program
• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program
• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin)
• Agrees to use acceptable methods of birth control during and for 12 months after completion of study drug therapy (applies to all men, and women of child bearing potential)
• Females must follow pregnancy testing requirements as outlined in the Revlimid REMS™ program

You may not qualify if:

• 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
• 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
• Known anti-human anti-chimeric antibody formation
• Treatment with infliximab, adalimumab, or etanercept within the past 12 months.
• Currently taking azathioprine, 6-mercaptopurine, methotrexate, mycophenolate mofetil, or other conventional immunomodulators. Patients receiving these drugs must discontinue them prior to enrollment
• Other investigational medication within the previous one month

Sponsors & Collaborators

• Mayo Clinic: lead
• Celgene Corporation: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease; Autoimmune Pancreatitis; Retroperitoneal Fibrosis

Interventions

Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Pancreatitis, Chronic; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mark D Topazian, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 10, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)