Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors (NCT03771157) | Clinical Trial Compass
CompletedEarly Phase 1
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
United States33 participantsStarted 2019-02-01
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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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.
What they're measuring
1
Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration
Timeframe: 4 weeks following the second vaccination, at approximately 3 months