Celiac Support Association

Refractory Celiac Disease Clinical Trial MAYO 

NEW – RECRUITING Participants with a potential or current diagnosis of Refractory Celiac Disease; MAYO Clinic Rochester, MN. First trial for a novel therapy for this most feared complication of celiac disease.    Link to the Clinical Trial page for this study. 

Official Title:       Phase I Study of the Humanized Mik-Beta-1 Monoclonal Antibody Directed Toward IL-2/IL-15R Beta (CD122) That Blocks IL-15 Action In Patients With Refractory Celiac Disease 

Are YOU Eligible?

18 Years and older
Male or female
Not accepting Healthy Volunteers

  • CRITERIA

  1. Patients must be greater than or equal to 18-years-old.
  2. All patients must have a pathologically confirmed diagnosis of refractory celiac disease(RCD) defined by internationally accepted criteria of persistent and recurrent symptoms(diarrhea, weight loss, and abdominal pain) associated with intestinal damage, characterized by partial to total villous atrophy with intraepithelial lymphocytes defined by > 25 intraepithelial lymphocytes per 100 epithelial cells.
  3. Persistence of the above signs and symptoms despite strict adherence to a gluten-free diet for 6-12 months
  4. Patients are to have had circulating antibodies to transglutaminase-1 or similar celiac specific serology
  5. Patients must have a life expectancy of > 3 months
  6. Patients must have a creatinine of less than 2.0 mg/dL or if the patient has an elevated creatinine measured creatinine clearance (Ccr) must be > 60 mL/min/1.73m(2)
  7. Patients must have a serum alkaline phosphatase, ALT (SGPT) and AST (SGOT) less than 3x the upper limits of normal (ULN)
  8. Patients must have a total bilirubin of less than 2.5 x ULN
  9. Women of childbearing potential must have a negative beta HCG pregnancy test at initial screening and within 3 days prior to registration
  10. Patients receiving a stable dose (> 4 weeks) of corticosteroid therapy equal to 20 mg of prednisone per day or less are eligible
  11. Patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine surface will be allowed on the study
  12. Patients must be able to understand and sign an informed consent

EXCLUSION CRITERIA

  • Serum alanine transaminase, aspartate transaminase or creatinine kinase > 2 x the upper limits of normal
  • Serum creatinine level > 1.5 mg/dL
  • INR greater than or equal to 1.5
  • Platelet count < 85,000/mm(3)
  • Total white blood cell count (WBC) < 300/mm(3)
  • Abnormal screening/baseline tests exceeding the limits outlined below:
  • Patients with significant co-morbidities including uncontrolled hypertension (diastolic B/P > 115 mm/Hg), unstable angina, congestive heart failure (> N.Y.H.A. Class II), poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty or myocardial infarction within the last 6 months or uncontrolled atrial or ventricular cardiac arrhythmias.
  • Pregnant or breastfeeding women. Women who not using an acceptable method of contraception. Acceptability of various methods of contraception will be determined by the investigator. Postmenopausal or surgically sterile women who have documentation of postmenopausal status or surgical sterility availability prior to enrollment.
  • Patients who have chronic hepatitis B or chronic hepatitis C
  • Patients with HIV infection (antibody positive) with positive confirmatory molecular tests
  • History of malignancy (active or within the previous 5 years)
  • Any uncontrolled or chronic bacterial, mycobacterial or other viral (e.g., herpes virus), fungal, parasitic or protozoal infection
  • A contraindication to monoclonal antibody therapy including adverse events related to prior monoclonal antibody therapy. Patients who have received prior antibody therapy will have permanent medical records reviewed by the study investigator.
  • Patients with antibodies to Hu-Mik-Beta-1
  • Patients with a history of venous thrombosis
  • Patients enrolled in another therapeutic study
  • Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol, and the required follow-up
  • Exclusion at the discretion of the PI or delegate if participation in the study is deemed too risky (e.g., clinically significant pleural or pericardial effusion or ascites)
  • Inability to give informed consent

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. Please refer to this study by its ClinicalTrials.gov identifier: NCT01893775

Contact: Thomas A Waldmann, M.D.        (301) 496-6656   [email protected]
Mayo Clinic, Rochester, Minnesota, United States, 55905
Contact: Carol Van Dyke    507-266-7842    [email protected]  
Contact: Deanna Brogan    (507) 538-1206    [email protected]
Sponsors and Collaborators: 
National Cancer Institute (NCI)
Mayo Clinic Principal Investigator:     Thomas A Waldmann, M.D.          National Cancer Institute (NCI)   

Publications:

Trier JS. Celiac sprue. N Engl J Med. 1991 Dec 12;325(24):1709-19. Review.
Ryan BM, Kelleher D. Refractory celiac disease. Gastroenterology. 2000 Jul;119(1):243-51. Review.
Cellier C, Delabesse E, Helmer C, Patey N, Matuchansky C, Jabri B, Macintyre E, Cerf-Bensussan N, Brousse N. Refractory sprue, coeliac disease, and enteropathy-associated T-cell lymphoma. French Coeliac Disease Study Group. Lancet. 2000 Jul 15;356(9225):203-8.

Responsible Party:            National Institutes of Health Clinical Center (CC)  National Cancer Institute (NCI) NCT01893775     Study First Received:       May 23, 2013

Last Updated:     April 16, 2015

Health Authority:              United States: Federal Government

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