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Protocol Details

Response to the HEPLISAV-B Hepatitis B Vaccine in Treatment Naive Chronic Lymphocytic Leukemia (CLL) and CLL Treated with Bruton's -Tyrosine Kinase Inhibitor (BTK-I)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-H-0145

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

Children;
Non-English Speaking

Special Instructions

Currently Not Provided

Keywords

Ibrutinib;
Acalabrutinib;
Immunology

Recruitment Keyword(s)

None

Condition(s)

Hepatitis;
Safety and Tolerability

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: HEPLISAV-B

Supporting Site

National Heart, Lung, and Blood Institute

Background:

People with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) tend to get infections more easily. This is because their immune systems are weakened. Hepatitis B is a virus that can be transmitted when body fluids from an infected person enter the body of an uninfected person. This virus can be dangerous for people with leukemia and lymphoma. HEPLISAV-B is a new hepatitis B vaccine. Researchers want to see if it can protect people with CLL/SLL from getting hepatitis B.

Objective:

To learn how HEPLISAV-B works in people who have CLL or SLL.

Eligibility:

Adults 18 years and older with CLL (or SLL). They must be getting no treatment for their CLL, or getting ibrutinib or acalabrutinib for it.

Design:

This study lasts 6 months from the date of first vaccination.

Participants may be screened with:

Physical exam

Blood tests

Pregnancy test

Visit 1

Participants will get blood drawn and the study vaccine. It will be given as an injection. If they get any symptoms within 7 days of the vaccine, they will write them in a diary.

Visit 2

After 3 months, participants will come back to the NIH to get another blood draw and the second vaccine dose.

Visit 3

Participants will return 3 months after the second vaccine dose was given. They will have blood drawn.

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Eligibility

INCLUSION CRITERIA:

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

-No known active or past hepatitis B infection

-No history of prior hepatitis B virus vaccination (approved or investigational)

-History of negative hepatitis B viral titers (negative HBsAg, HBsAb and HBcAb)

-Cohort 1: Treatment naive CLL patients

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

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

- Age greater than or equal to 18 years.

-ECOG performance status of 0-1

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

EXCLUSION CRITERIA:

-Female patients who are currently pregnant.

-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

-History of severe allergic reaction to any component of HEPLISAV-B, including yeast

-Receive intravenous or subcutaneous immunoglobulin (IVIG) within 3 months prior to vaccination

-Concomitant use of immunosuppressive agents (e.g. steroids, radiotherapy, chemotherapy)

-Hereditary or acquired immunodeficiency syndrome unrelated to CLL

-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)



Emeline M. Maddux
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 6-3152
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7094
emeline.maddux@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:

NCT03685708

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