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

University of Rochester

Status and phase: Completed; Early Phase 1

Conditions: Waldenstrom Macroglobulinemia (WM); Chronic Lymphocytic Leukemia (CLL)

Treatments: Drug: Shingrix vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03771157

00003112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Shingrix shingles vaccine treatment

Experimental group

Description:

On day one, patients will receive the first of two doses of the Shingrix vaccine administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.

Treatment:

Drug: Shingrix vaccine