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Protocol Details

Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients that are Treatment Na(SqrRoot) ve or Receiving Bruton s-tyrosine Kinase Inhibitor (BTK-I) Therapy

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-H-0001

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Children

Special Instructions

Currently Not Provided

Keywords

Ibrutinib;
Acalabrutinib;
Shingles;
Herpes

Recruitment Keyword(s)

None

Condition(s)

Safety and Tolerability;
Compare SHINGRIX Vaccine Response Rates

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: Zoster Vaccine Recombinant, Adjuvanted

Supporting Site

National Heart, Lung, and Blood Institute

Background:

People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles. Scientists had thought people with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Now there is a new shingles vaccine that is not live and cannot cause shingles. The new shingles vaccine may protect people with weak immune systems from getting shingles. This is currently shown to be safe to give people 50 years and older to prevent shingles. Researchers want to test how safe the vaccine is and how it works in people with CLL.

Objective:

To learn how a new shingles vaccine works in people who have chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL).

Eligibility:

Adults ages 18 years and older with CLL or SLL who are not being treated for CLL or who are getting certain treatments.

Design:

Participants will be screened with a chart review or through another protocol.

Visit 1

At visit 1, participants may have a pregnancy test, blood test, or physical exam.

Pregnant participants cannot be in the study.

Eligible participants will get the shingles vaccine as an injection.

Participants will receive a diary and write down any sumptoms they have for 7 days after the vaccines.

Visit 2

Visit 2 will be 3 months later. Participants will have blood taken and get another dose of the vaccine.

Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines.

Visit 3

Visit 3 will be 3 months after visit 2. Participants will have blood taken.

Participants may be able to get an additional vaccine the same day as the shingles vaccine.

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Eligibility

INCLUSION CRITERIA:

-Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI Working Group

-Cohort 1:Treatment naive CLL/SLL patients

-Cohort 2: Subjects must be receiving treatment ibrutinib for at least 6 months prior to administration of the first vaccine dose

-Cohort 3: Subjects must be receiving acalabrutinib for at least 6 months prior to administration of the first vaccine dose

-No active, symptomatic VZV or herpes zoster infection within 12 months prior to vaccination

-No exposure to the live VZV vaccine (ZOSTAVAX) within 12 months prior to vaccination

-No prior exposure to the SHINGRIX vaccine

-Age greater than or equal to 18 years.

-ECOG performance status of 0-2

-Able to comprehend the investigational nature of the protocol and provide informed consent

EXCLUSION CRITERIA:

-Female patients who are currently in pregnancy

-Any uncontrolled active systemic infection

-Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk

-Severe allergic reaction to any component of SHINGRIX.

-Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination.

-Concomitant use of immunosuppressive agents (e.g. steroids, radio

therapy, chemotherapy)

-Hereditary or acquired immunodeficiency syndrome unrelated to chronic lymphocytic leukemia

-Non-English speaking individuals will be excluded from the study


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Christopher M. Pleyer, M.D.
National Heart, Lung and Blood Institute (NHLBI)



Susan Soto, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 4-5362
10 Center Drive
Bethesda, Maryland 20892
(301) 402-0797
sotos@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03702231

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