Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors

NCT03771157 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 00003112
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.

Conditions

Chronic Lymphocytic Leukemia (CLL); Waldenstrom Macroglobulinemia (WM)

Keywords

shingles vaccine (Shingrix); Chronic lymphocytic leukemia (CLL); Waldenstrom macroglobulinemia (WM); Pilot Study

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration

  Vaccine response, as determined by blood antibody levels to the varicella virus glycoprotein E subunit (anti-gE); Baseline is defined as pre-vaccination anti-gE titer in seropositive subjects, and the lower limit of detection in seronegative subjects

  4 weeks following the second vaccination, at approximately 3 months

Secondary Outcomes (1)

• Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration

  4 weeks following the second vaccination, at approximately 3 months

Other Outcomes (2)

• Number of Participants With Humoral Response to Vaccination 2 Years After the Second Vaccine Administration

  2 years following second vaccination, approximately 26 months from day 1

• Number of Participants With Cellular Response to Vaccination 2 Years After the Second Vaccine Administration

  2 years following second vaccination, approximately 26 months from day 1

Study Arms (1)

Shingrix shingles vaccine treatment

EXPERIMENTAL

On day one, patients will receive the first of two doses of the Shingrix vaccine administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.

Drug: Shingrix vaccine

Interventions

Shingrix vaccine DRUG

On day one, patients will receive the first of two doses of the Shingrix vaccine administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.

Also known as: Herpes Zoster Vaccine Recombinant, Adjuvanted

Shingrix shingles vaccine treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They are at least 50 years of age;
• Have been diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström's macroglobulinemia (WM)
• Have been on first-line BTK inhibitor (ie ibrutinib or acalabrutinib) for at least 3 months,
• Prior treatment with single agent rituximab is permitted if last dose was administered over one year ago;
• Have at least a one-year life expectancy;
• Have a history of varicella (chicken-pox) OR lived in the US or any endemic country for \> 30 years.
• Prior radiation therapy is allowed

You may not qualify if:

• They have a known hypersensitivity to a vaccine component;
• Had herpes zoster reactivation within the past year;
• Had received or were scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post-second dose;
• Had received or were scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post- second dose;
• Are unable to give informed consent;
• Have absolute lymphocyte counts greater than 20,000 X 109/L;
• Are receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor;
• Had rituximab treatment within a year prior to study start;
• Had prior chemotherapy.

Sponsors & Collaborators

• University of Rochester: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Waldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Results Point of Contact

• Title: Michael Brady
• Organization: University of Rochester

michael_brady@urmc.rochester.edu

585-276-3203

Study Officials

• Jonathan Friedberg, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Wilmot Cancer Institute

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 10, 2018
• Study Start: February 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: August 3, 2022
• Last Updated: March 15, 2024
• Results First Posted: January 22, 2024

Record last verified: 2024-02

Locations

US (1)