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Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)

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ClinicalTrials.gov Identifier: NCT03702231
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date  ICMJE October 10, 2018
First Posted Date  ICMJE October 11, 2018
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE December 7, 2018
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
Response to the SHINGRIX vaccine in untreated CLL patients and CLL patients treated with BTK-inhibitors [ Time Frame: 6 months after the first vaccine administration ]
Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement following completion of the SHINGRIX 2-dose vaccine series in CLL patients that are treatment naive or receiving therapy with a BTK-inhibitor
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03702231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
Safety and Tolerabilty of the SHINGRIX vax in CLL pts. [ Time Frame: 6 months after the first vaccine administration ]
Determine the safety and tolerability of the SHINGRIXvaccine among CLL patients who are treatment naive or receiving a Bruton s-tyrosine kinase inhibitor (BTK-I) (ibrutinib or acalabrutinib).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
Safety and Tolerabilty of the SHINGRIX vax in CLL pts. [ Time Frame: 6 months after the first vaccine administration ]
Determine the safety and tolerability of the SHINGRIXvaccine among CLL patients who are treatment na(SqrRoot) ve or receiving a Bruton s-tyrosine kinase inhibitor (BTK-I) (ibrutinib or acalabrutinib).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)
Official Title  ICMJE Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients That Are Treatment Naive or Receiving Bruton s-Tyrosine Kinase Inhibitor (BTK-I) Therapy
Brief Summary

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.

Detailed Description

This study aims to determine the efficacy of the SHINGRIX varicella zoster virus (VZV) vaccine 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
  • Age 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 SHINGRIX vaccine efficacy in patients who are treatment naive or receiving BTK-I therapy. A series of 2 doses of SHINGRIX will be given at 0- and 3- month schedule by intramuscular injection. Subjects will be followed for 6 months and receive assessment of serologic response 6 months after the first vaccine dose administration.

Study Objectives:

Primary Objective:

a)Determine the serologic response against VZV after completing the SHINGRIX (RZV) 2-

dose vaccine series in the following populations:

-CLL patients that are treatment naive (n=54)

  • CLL patients receiving treatment with ibrutinib (n=27)
  • CLL patients receiving treatment with acalabrutinib (n=27)

Secondary Objective:

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Safety and Tolerability
  • Compare SHINGRIX Vaccine Response Rates
Intervention  ICMJE Biological: Zoster VaccineRecombinant, Adjuvanted
Patients with CLL will enroll on the study for the purpose of determining the SHINGRIX vaccine efficacy in patients who are treatment naive or receiving BTK-I therapy. A series of 2 doses of SHINGRIX will be given on a 0- and 3-month schedule by intramuscular injection. Subjects will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
Study Arms  ICMJE Experimental: Arm 1
Patients with CLL
Intervention: Biological: Zoster VaccineRecombinant, Adjuvanted
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2018)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2020
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:
  • Diagnosis of CLL
  • Cohort 1:Treatment na1ve CLL 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Susan Soto, R.N. (301) 402-0797 sotos@nhlbi.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03702231
Other Study ID Numbers  ICMJE 190001
19-H-0001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher MT Pleyer, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 17, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP