Response to the HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients that are Treatment Naive or Receiving Bruton s-tyrosine Kinase Inhibitor (BTK-I) Therapy

  • STATUS
    Recruiting
Updated on 9 April 2019
chronic lymphocytic leukemia
lymphoma
ibrutinib
acalabrutinib

Summary

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.

 

Description

This study aims to determine the HEPLISAV-B hepatitis B vaccine efficacy in chronic lymphocytic leukemia (CLL) patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I) therapy.

Key Eligibility Criteria:

  • Diagnosis of CLL
  • 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
  • No known active or past hepatitis B infection
  • History of prior hepatitis B virus vaccination (approved or investigational)
  • Age greater greater than or equal to 18 years.
  • ECOG performance status of 0-1

Design:

Patients with CLL will enroll on the study for the purpose of determining the HEPLISAV-B vaccine efficacy in patients who are treatment naive ore receiving BTK-I therapy. A series of 2 doses of HEPLISAV-B will be given on a 0- and 3- month schedule by intramuscular injection. Subjects will be followed at regular intervals and receive serologic response assessment following completion of the HEPLISAV-B vaccine series (6 months after the first vaccine administration).

Study Objectives:

Primary Objective:

  • Determine the rate of hepatitis B seroprotective titer achievement (anti-HBs greater than or equal to 10mIU/mL) following completion of the HEPLISAV-B 2-dose vaccine series (6 months after the first vaccine administration) in the following populations:
    • CLL patients who are treatment naive (n=54)
    • CLL patients receiving treatment with ibrutinib (n=27)
    • CLL patients receiving treatment with acalabrutinib (n=27)

Secondary Objective:

  • Determine the safety and tolerability of the HEPLISAV-B vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib).

 

Details
Condition Chronic Lymphocytic Leukemia
Clinical Study IdentifierTX218183
Last Modified on9 April 2019

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 99 yrs?
Gender: Male or Female
Do you have Chronic Lymphocytic Leukemia?
Diagnosis of CLL/SLL [hereafter CLL/SLL will be referred to as CLL] 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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