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)

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT03702231
Collaborator
(none)
116
Enrollment
1
Location
3
Arms
55.1
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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 symptoms 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Zoster Vaccine Recombinant, Adjuvanted
Phase 2

Detailed Description

This study aims to determine the efficacy of the SHINGRIX varicella zoster virus (VZV) vaccine in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I). (Note: Since CLL and SLL are considered the same disease, CLL/SLL will be referred to as CLL hereafter, unless otherwise specified).

Key Eligibility Criteria:
  • Diagnosis of CLL or SLL

  • Cohort 1: Treatment naive CLL or SLL patients

  • Cohort 2: Subjects must be receiving 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

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

Study Design

Study Type:
Interventional
Actual Enrollment :
116 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Dec 7, 2018
Actual Primary Completion Date :
Sep 9, 2020
Anticipated Study Completion Date :
Jul 12, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Chronic Lymphocytic Leukemia Patients That Are Treatment Naive

Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.

Biological: Zoster Vaccine Recombinant, Adjuvanted
A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
Other Names:
  • SHINGRIX
  • Experimental: Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib

    Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.

    Biological: Zoster Vaccine Recombinant, Adjuvanted
    A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
    Other Names:
  • SHINGRIX
  • Experimental: Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib

    Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.

    Biological: Zoster Vaccine Recombinant, Adjuvanted
    A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
    Other Names:
  • SHINGRIX
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer [6 months after the first vaccine administration]

      Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement in participants following completion of the SHINGRIX 2-dose vaccine series in Chronic Lymphocytic Leukemia (CLL) patients that are treatment naive or receiving therapy with a Bruton Tyrosine Kinase (BTK) Inhibitor (Ibrutinib or Acalabrutinib). The response criteria for achieving serologic response against VZV following the SHINGRIX vaccine are based on a validated luciferase immunoprecipitation assay detecting VZV antiglycoprotein E antibody. The primary endpoint is serologic response defined as ≥ four-fold rises in VZV anti-gE blood. IgG titer achievement after completing the SHINGRIX (RZV) 2-dose vaccine series.

    Secondary Outcome Measures

    1. Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients. [6 months after the first vaccine administration]

      Determine the safety and tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (Ibrutinib or Acalabrutinib).

    2. Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients. [6 months after the first vaccine administration]

      Determine the tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (Ibrutinib or Acalabrutinib).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical CenterBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Christopher MT Pleyer, M.D., National Heart, Lung, and Blood Institute (NHLBI)

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Heart, Lung, and Blood Institute (NHLBI)
    ClinicalTrials.gov Identifier:
    NCT03702231
    Other Study ID Numbers:
    • 190001
    • 19-H-0001
    First Posted:
    Oct 11, 2018
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleChronic Lymphocytic Leukemia Patients That Are Treatment NaiveChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
    Arm/Group DescriptionChronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
    Period Title: Overall Study
    STARTED592928
    COMPLETED552526
    NOT COMPLETED442

    Baseline Characteristics

    Arm/Group TitleChronic Lymphocytic Leukemia Patients That Are Treatment NaiveChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibTotal
    Arm/Group DescriptionChronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Total of all reporting groups
    Overall Participants592928116
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    25
    42.4%
    7
    24.1%
    16
    57.1%
    48
    41.4%
    >=65 years
    34
    57.6%
    22
    75.9%
    12
    42.9%
    68
    58.6%
    Sex: Female, Male (Count of Participants)
    Female
    27
    45.8%
    14
    48.3%
    8
    28.6%
    49
    42.2%
    Male
    32
    54.2%
    15
    51.7%
    20
    71.4%
    67
    57.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    3.4%
    1
    3.4%
    1
    3.6%
    4
    3.4%
    Not Hispanic or Latino
    56
    94.9%
    28
    96.6%
    26
    92.9%
    110
    94.8%
    Unknown or Not Reported
    1
    1.7%
    0
    0%
    1
    3.6%
    2
    1.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    3.4%
    2
    6.9%
    2
    7.1%
    6
    5.2%
    White
    56
    94.9%
    26
    89.7%
    25
    89.3%
    107
    92.2%
    More than one race
    1
    1.7%
    1
    3.4%
    1
    3.6%
    3
    2.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    59
    100%
    29
    100%
    28
    100%
    116
    100%

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer
    DescriptionDetermine the rate of varicella zoster virus (VZV) seroprotective titer achievement in participants following completion of the SHINGRIX 2-dose vaccine series in Chronic Lymphocytic Leukemia (CLL) patients that are treatment naive or receiving therapy with a Bruton Tyrosine Kinase (BTK) Inhibitor (Ibrutinib or Acalabrutinib). The response criteria for achieving serologic response against VZV following the SHINGRIX vaccine are based on a validated luciferase immunoprecipitation assay detecting VZV antiglycoprotein E antibody. The primary endpoint is serologic response defined as ≥ four-fold rises in VZV anti-gE blood. IgG titer achievement after completing the SHINGRIX (RZV) 2-dose vaccine series.
    Time Frame6 months after the first vaccine administration

    Outcome Measure Data

    Analysis Population Description
    116 patients enrolled in study and 106 patients were analyzed. 10 patients did not complete study.
    Arm/Group TitleChronic Lymphocytic Leukemia Patients That Are Treatment NaiveChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
    Arm/Group DescriptionChronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
    Measure Participants572524
    Count of Participants [Participants]
    44
    74.6%
    10
    34.5%
    9
    32.1%
    2. Secondary Outcome
    TitleNumber of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
    DescriptionDetermine the safety and tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (Ibrutinib or Acalabrutinib).
    Time Frame6 months after the first vaccine administration

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleChronic Lymphocytic Leukemia Patients That Are Treatment NaiveChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
    Arm/Group DescriptionChronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
    Measure Participants592928
    Count of Participants [Participants]
    1
    1.7%
    0
    0%
    0
    0%
    3. Secondary Outcome
    TitleNumber of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
    DescriptionDetermine the tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (Ibrutinib or Acalabrutinib).
    Time Frame6 months after the first vaccine administration

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleChronic Lymphocytic Leukemia Patients That Are Treatment NaiveChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
    Arm/Group DescriptionChronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
    Measure Participants592928
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time FrameEvents will be collected for 7 days following the first and second vaccine dose
    Adverse Event Reporting Description All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
    Arm/Group TitleChronic Lymphocytic Leukemia Patients That Are Treatment NaiveChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
    Arm/Group DescriptionChronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
    All Cause Mortality
    Chronic Lymphocytic Leukemia Patients That Are Treatment NaiveChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/59 (0%) 0/29 (0%) 0/28 (0%)
    Serious Adverse Events
    Chronic Lymphocytic Leukemia Patients That Are Treatment NaiveChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/59 (1.7%) 0/29 (0%) 0/28 (0%)
    Infections and infestations
    Lung Infection1/59 (1.7%) 10/29 (0%) 00/28 (0%) 0
    Other (Not Including Serious) Adverse Events
    Chronic Lymphocytic Leukemia Patients That Are Treatment NaiveChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total58/59 (98.3%) 29/29 (100%) 27/28 (96.4%)
    Gastrointestinal disorders
    Nausea0/59 (0%) 00/29 (0%) 04/28 (14.3%) 4
    Nausea10/59 (16.9%) 117/29 (24.1%) 80/28 (0%) 0
    General disorders
    Chills13/59 (22%) 176/29 (20.7%) 94/28 (14.3%) 4
    Edema limbs3/59 (5.1%) 41/29 (3.4%) 11/28 (3.6%) 1
    Fatigue31/59 (52.5%) 5112/29 (41.4%) 2215/28 (53.6%) 31
    Flu like symptoms22/59 (37.3%) 364/29 (13.8%) 59/28 (32.1%) 12
    Injection site reaction47/59 (79.7%) 10320/29 (69%) 3915/28 (53.6%) 28
    Pain58/59 (98.3%) 19128/29 (96.6%) 6627/28 (96.4%) 72
    Fever6/59 (10.2%) 62/29 (6.9%) 20/28 (0%) 0
    Headache1/59 (1.7%) 12/29 (6.9%) 20/28 (0%) 0
    Myalgia1/59 (1.7%) 23/29 (10.3%) 70/28 (0%) 0
    Vaccination complication2/59 (3.4%) 33/29 (10.3%) 50/28 (0%) 0
    Vaccination site lymphadenopathy7/59 (11.9%) 92/29 (6.9%) 20/28 (0%) 0
    Musculoskeletal and connective tissue disorders
    Myalgia33/59 (55.9%) 5711/29 (37.9%) 2413/28 (46.4%) 24
    Nervous system disorders
    Headache37/59 (62.7%) 6113/29 (44.8%) 199/28 (32.1%) 13
    Dizziness3/59 (5.1%) 42/29 (6.9%) 30/28 (0%) 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular7/59 (11.9%) 83/29 (10.3%) 50/28 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleChristopher Pleyer, M.D. Principal Investigator, NIH, NHLBI
    OrganizationNational Institutes of Health (NIH) / The National Heart, Lung, and Blood Institute (NHLBI)
    Phone510.709.6649
    Emailchristopher.pleyer@nih.gov
    Responsible Party:
    National Heart, Lung, and Blood Institute (NHLBI)
    ClinicalTrials.gov Identifier:
    NCT03702231
    Other Study ID Numbers:
    • 190001
    • 19-H-0001
    First Posted:
    Oct 11, 2018
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Jan 1, 2022