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:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT03771157
Eligibility Criteria:
Inclusion Criteria:
* They are at least 50 years of age;
* Have been diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström's macroglobulinemia (WM)
* Have been on first-line BTK inhibitor (ie ibrutinib or acalabrutinib) for at least 3 months,
* Prior treatment with single agent rituximab is permitted if last dose was administered over one year ago;
* Have at least a one-year life expectancy;
* Have a history of varicella (chicken-pox) OR lived in the US or any endemic country for \> 30 years.
* Prior radiation therapy is allowed
Exclusion Criteria:
* They have a known hypersensitivity to a vaccine component;
* Had herpes zoster reactivation within the past year;
* Had received or were scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post-second dose;
* Had received or were scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post- second dose;
* Are unable to give informed consent;
* Have absolute lymphocyte counts greater than 20,000 X 109/L;
* Are receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor;
* Had rituximab treatment within a year prior to study start;
* Had prior chemotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03771157
Study Brief:
Protocol Section:
NCT03771157