Last updated on April 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Safety and Tolerability | Chronic Lymphocytic Leukemia | CLL
  • Age: Between 18 - 99 Years
  • Gender: Male or Female

 

INCLUSION CRITERIA:

  • 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.