Clinical trial NCT03771157: Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
Official title: Serologic Response to a New Recombinant, Adjuvanted Herpes Zoster Vaccine in Patients With Chronic Lymphocytic Leukemia and Waldenström Macroglobulinemia Treated With First-Line BTK Inhibitors - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Lymphocytic Leukemia (CLL)
Waldenstrom Macroglobulinemia (WM)
Keywords: shingles vaccine (Shingrix)
Chronic lymphocytic leukemia (CLL)
Waldenstrom macroglobulinemia (WM)
Pilot Study
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2018-12-10
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 vaccine under first-line BTK inhibitors.

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, adjuvanted herpes zoster vaccine (Shingrix) is currently being offered to these populations, no study has specifically evaluated them.

The purpose of the study is to complete a single-arm trial evaluating if patients with CLL or WM, while on treatment with first-line BTK inhibitors, can achieve immunologic response to Shingrix. If effective, this will result in a new, well-tolerated shingles prevention strategy for these patients.

The primary objective is to assess the capability to mount a humoral immune response to Shingrix in patients with CLL or WM 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration
timeFrame: 4 weeks following the second vaccination, at approximately 3 months
Other outcomes:
measure: Number of Participants With Humoral Response to Vaccination 2 Years After the Second Vaccine Administration
timeFrame: 2 years following second vaccination, approximately 26 months from day 1
measure: Number of Participants With Cellular Response to Vaccination 2 Years After the Second Vaccine Administration
timeFrame: 2 years following second vaccination, approximately 26 months from day 1
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jonathan Friedberg, MD
role: PRINCIPAL_INVESTIGATOR
References: