Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Vaccines

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.