Status:
COMPLETED
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Waldenstrom Macroglobulinemia (WM)
Eligibility:
All Genders
50+ years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
Chronic lymphocytic leukemia (CLL) and Waldenstrom's macroglobulinemia (WM) are known risk factors for zoster reactivation, commonly called shingles. Although a recently FDA-approved recombinant, adju...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03771157
Start Date
February 1 2019
End Date
August 3 2022
Last Update
March 15 2024
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14623