A Study to Evaluate Expanded Access to Mepolizumab for Patients with Hypereosinophilic Syndrome

Overview

About this study

The purpose of this study is to provide a mechanism for expanded access to mepolizumab therapy for eligible patients with Hypereosinophilic Syndrome (HES).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

 

  • In accordance with local procedures, written informed consent/assent can be obtained from the patient or legally authorized representative.
  • ≥ 12 years of age at the time of signing the informed consent/assent.
  • Meets the diagnostic criteria for HES as defined by:
    • Eosinophilia >1500 cells/μl for at least 6 months with evidence of symptoms and signs of organ system involvement or dysfunction that can be directly related to eosinophilia (with no evidence of parasitic, allergic or other recognised causes of eosinophilia such as connective tissues disease, malignancy); or
    • Eosinophilia of >1500 cells/μl for less than 6 months and meet the other criteria for HES accompanied by clear evidence of eosinophil tissue infiltration and with exclusion of secondary causes of eosinophilia as above.
  • Patients meeting all three of the following criteria will be eligible:
    • The indication, HES, is a seriously debilitating or life-threatening disease;
    • There is no satisfactory alternative treatment: documented failure (lack of efficacy or a contra-indication) to at least 3 standard therapies (corticosteroids, cytotoxic agents, immunomodulatory therapy, and Imatinib mesylate) at the appropriate duration and dose or demonstrated clinical benefit from prior treatment with mepolizumab; and
    • There is reason to believe that the benefit:risk ratio for mepolizumab in the indication is positive.

Exclusion Criteria:

  • Patients without HES but with other conditions associated with eosinophilic pathological processes such as eosinophilic granulomatosis with polyangiitis [EGPA], Wegener’s granulomatosis, atopic disorders, parasitic infections, eosinophilic
  • gastroenteropathies. 
  • Female patients of childbearing potential who are not using a highly effective
  • method of contraception:
    • Consistent and correct use of an acceptable method of birth control for one month prior to the start of the investigational medicine and until 16 weeks after the last dose.
  • Pregnant or lactating females
  • Patients with severe/life-threatening underlying disease unrelated to HES where life expectancy is estimated to be less than 3 months.
  • Patients with a history of or current malignancy:
    • Patients with a history of or current lymphoma;
    • Patients with current malignancy or previous history of cancer in remission for less than 12 months prior to the first dose. Patients that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.
  • Patients with history of serious allergic reaction (hypersensitivity/anaphylaxis) to anti-IL5 or other antibody therapy or known or suspected hypersensitivity to any component of mepolizumab, leading to treatment discontinuation.
  • Patients with current drug or alcohol abuse where uncertain compliance with the protocol and/or with the medical management instruction of the treating physician may cause safety risk.
  • Patients who have received treatment with an investigational agent (biologic or nonbiologic, excluding mepolizumab) within the past 30 days or 5 drug half-lives whichever is longer, prior to the administration of mepolizumab under this protocol.  The term “investigational” applies to any drug not approved for sale in the country in which it is being used or investigational formulations of marketed products.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Thanai Pongdee, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Matthew Rank, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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Additional contact information

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Phone: 800-664-4542 (toll-free)

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