Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT02419560
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed with Mantle Cell Lymphoma and has had at least one chemotherapy.
2. Subjects must have measurable or evaluable disease.
3. ECOG Performance Status of 0-2.
4. Must be referred for treatment with ibrutinib.
5. Must have adequate organ function.
Exclusion Criteria:
1. Subject is pregnant.
2. Prior malignancy (except nonmelanomatous skin cancer) unless disease free for a minimum of 2 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.
3. Known CNS lymphoma.
4. Prior or current treatment with certain medications. Talk to Study Contact for specifics.
5. Subject is at high risk for TLS.
6. Subject has malabsorption syndrome or other condition which may affect an enteral route of administration.
7. Subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.
8. Significant history of heart disease.
9. Subject has an active infection.
10. Known active Hepatitis B or Hepatitis C.
11. A serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02419560
Study Brief:
Protocol Section:
NCT02419560