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

NCT03771157 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-03-15

Study results available
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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.

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Waldenstrom Macroglobulinemia (WM)

Interventions

DRUG

Shingrix vaccine

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.

Sponsors & Collaborators

Principal Investigators

  • Jonathan Friedberg, MD · University of Rochester

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-09-01
Completion
2022-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03771157 on ClinicalTrials.gov