Study to Assess the Safety and Effectiveness of Shingrix Vaccine in Patients with Hematologic Malignancies

Overview

About this study

The purpose of this study is to compare the response of Shingrix vaccination among patients with untreated MBL and low-risk CLL to patients with untreated intermediate and high-risk CLL.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

All patients with MBL/CLL seen at Mayo Clinic, Rochester, MN will be considered for participation in this study.

  • All patients who consent to participate will be assigned to one of five arms of the study:
    • Arm A: previously untreated MBL or CLL Rai stage 0;
    • Arm B: previously untreated CLL Rai Stage I-IV;
    • Arm C: CLL patients who are currently receiving therapy with single-agent ibrutinib;
    • Arm D: Patients who have undergone an allogeneic stem cell transplant, regardless of the indication for transplant;
    • Arm E: CLL patients who are currently receiving therapy with single-agent Acalabrutinib.

Exclusion Criteria:

Patients who meet any of the following exclusion criteria will not be registered to this study:

  • Patients who have received Shingrix previously.
  • Patients receiving therapy with other BTK inhibitors such as acalabrutinib, or other targeted agents such as venetoclax, etc.
  • Patients receiving any other concomitant CLL directed therapy such as anti-CD20 monoclonal antibody (such as rituximab, ofatumumab or obinutuzumab).

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sameer Parikh, M.B.B.S.

Closed for enrollment

Contact information:

Matthew Holets

(507) 266-7208

Holets.Matthew@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions