RECRUITING

Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease

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Conditions

Interstitial Lung DiseaseCommon Variable Immunodeficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently looked promising for the treatment of patients with complex CVID. This study is a multi-site, phase II, randomized, blinded/placebo-controlled clinical trial in pediatric and adult subjects to determine the efficacy of abatacept compared to placebo for treatment of subjects with GLILD in the context of CVID. Funding Source - FDA OOPD

Official Title

Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease

Quick Facts

Study Start:2021-07-14
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04925375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of CVID according to the international consensus document (ICON)
  2. 1. Age 4 years or above
  3. 2. Serum IgG at least 2 standard deviations below the age adjusted normal
  4. 3. Decreased serum IgA and/or serum IgM
  5. 4. Abnormal specific antibody response to immunization
  6. 5. Exclusion of secondary immunodeficiency
  7. 2. On replacement immunoglobulin for at least 6 months and willing to maintain throughout study
  8. 3. Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.
  9. 4. Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 3 months of study entry.
  10. 5. Signed written informed consent
  11. 6. Willing to allow storage of biological specimens for future use in medical research.
  12. 7. Female subjects of childbearing potential must agree to an effective form of birth control such as hormone based contraceptive, intrauterine device, condoms/barrier, surgically sterile partner, or abstinence.
  13. 8. Fertile, non-vasectomized males with a female partner of childbearing potential should use condoms throughout the study and for 3 months after the last dose
  1. 1. History of hypersensitivity to abatacept or any of its components
  2. 2. Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months
  3. 3. Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as \>15mg/kg/day of methylprednisone or corticosteroid equivalent) within the past 3 months
  4. 4. Have started or increased any of the following immune modulating drugs within 3 months of enrolling and 3 months from initial CT chest: azathioprine, cyclosporine, tacrolimus, mercaptopurine, methotrexate, mycophenolate mofetil, or sirolimus
  5. 5. History of HIV infection (positive PCR)
  6. 6. Chronic untreated hepatitis B or C (positive PCR)
  7. 7. Active tuberculosis (TB) by positive QuantiFERON gold. If history of latent TB, then must supply evidence of completing treatment.
  8. 8. Persistent Epstein-Barr Virus (EBV) load ≥ 1,000 units/mL blood checked twice at least 1 month apart
  9. 9. Other uncontrolled infections
  10. 10. Live vaccine given within 6 weeks of the start of the trial
  11. 11. Malignancy or treated for malignancy within the past year
  12. 12. Currently pregnant or breast feeding
  13. 13. Life expectancy less than 1 month
  14. 14. Subjects unwilling to self-administer or have a parent/caregiver self-administer subcutaneous injections at home
  15. 15. Other conditions that the investigators feel contraindicate participation in the study

Contacts and Locations

Study Contact

Michael Jordan
CONTACT
513-803-9063
Michael.Jordan.@cchmc.org

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States
University of South Florida
Tampa, Florida, 33620
United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
United States
Mayo Clinic
Rochester, Minnesota, 55902
United States
Duke University Health System
Durham, North Carolina, 27710
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-14
Study Completion Date2025-07

Study Record Updates

Study Start Date2021-07-14
Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

  • Interstitial Lung Disease
  • Common Variable Immunodeficiency