Early Phase 1
N=32
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
Chronic Lymphocytic Leukemia (CLL) · Waldenstrom Macroglobulinemia (WM)
Bottom Line
View on ClinicalTrials.gov: NCT03771157 ↗Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Jan 2024
Primary outcome: Primary: Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration — 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Shingrix vaccine (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration |
24 | — |
| SECONDARY Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration |
26 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03771157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.