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Trial record 87 of 94 for:    Primary Sclerosing Cholangitis

Treatment of IgG4-Related Disease With Revlimid and Rituximab (TIGR2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02705638
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : July 8, 2019
Celgene Corporation
Information provided by (Responsible Party):
Thomas E. Witzig, M.D., Mayo Clinic

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?

Condition or disease Intervention/treatment Phase
Immunoglobulin G Subclass 4 Related Disease IgG4-related Disease Autoimmune Pancreatitis IgG4-related Sclerosing Cholangitis Retroperitoneal Fibrosis Drug: Rituximab Drug: Lenalidomide Phase 1

Detailed Description:
Immunoglobulin G subclass 4 Related Disease (IgG4-RD) is a recently recognized systemic fibroinflammatory condition. Various manifestations of IgG4-RD were previously recognized in individual organ systems, but these entities (including autoimmune pancreatitis, orbital pseudotumor, Reidel's thyroiditis, retroperitoneal fibrosis, idiopathic sialadenitis and dacryoadenitis, etc) are now recognized as manifestations of a common disease process that can affect any organ system. IgG4-RD is characterized by distinctive histologic findings of tissue infiltration by IgG4-positive plasma cells together with storiform fibrosis and obliterative phlebitis. Both clinical and pathologic consensus diagnostic criteria have been defined. Serum IgG4 concentration is a biomarker for IgG4-RD and is elevated in 70% to 90% of patients with active disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of IgG4-Related Disease With Revlimid and Rituximab: The TIGR2 Trial
Study Start Date : April 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Arm Intervention/treatment
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.
Drug: Rituximab
All subjects will receive Rituxan 1,000 mg intravenously on days 1 and 15.
Other Name: Rituxan

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Diagnosis of active IgG4-RD based on standard pathologic or clinical criteria (see below) and requiring medical treatment
  2. Patient is:

    1. in relapse after prior steroid and/or rituximab (RTX) treatment or while tapering steroid treatment, OR
    2. has disease that is refractory to steroids, OR
    3. has contraindications to steroid therapy (including diabetes, mood disorder, obesity)
  3. Absolute neutrophil count >1500 and platelet count >/= 100,000
  4. Calculated creatinine clearance (or estimated GFR) greater than or equal to 60ml/min
  5. 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
  6. Not pregnant or nursing
  7. 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
  8. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program
  9. 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)
  10. 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)
  11. Females must follow pregnancy testing requirements as outlined in the Revlimid REMS™ program

Exclusion criteria:

  1. 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
  2. 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
  3. Known immunodeficiency state
  4. New York Heart Association Classification III or IV heart disease
  5. Active malignancy requiring therapy
  6. Receipt of a live vaccine within 4 weeks prior to initiating study drug therapy.
  7. Allergies: History of severe allergic reactions to human or chimeric monoclonal antibodies, murine protein, or lenalidomide
  8. Substance abuse: Drug or alcohol abuse that could interfere with participation in the trial according to the protocol
  9. Known anti-human anti-chimeric antibody formation
  10. Treatment with infliximab, adalimumab, or etanercept within the past 12 months.
  11. Currently taking azathioprine, 6-mercaptopurine, methotrexate, mycophenolate mofetil, or other conventional immunomodulators. Patients receiving these drugs must discontinue them prior to enrollment
  12. Other investigational medication within the previous one month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02705638

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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Celgene Corporation
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Principal Investigator: Mark D Topazian, MD Mayo Clinic

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Responsible Party: Thomas E. Witzig, M.D., Principal Investigator, Mayo Clinic Identifier: NCT02705638    
Other Study ID Numbers: 15-003700
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cholangitis, Sclerosing
Immunoglobulin G4-Related Disease
Retroperitoneal Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors