Immune response to Shingrix vaccination in patients with chronic lymphocytic leukemia or Waldenstrom macroglobulinemia while undergoing treatment with BTK inhibitors

Phase 1

Completed

• Conditions: Chronic lymphocytic leukemia or Waldenstrom macroglobulinemia; Cancer

• Registration Number: ISRCTN78423540
• Lead Sponsor: niversity of Rochester

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37483138/ (added 16/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-03
• Study Start: 2023-11-16
• Last Update Posted: 28 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Patients diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström macroglobulinemia (WM)
2. 50 years of age or older
3. Receiving first-line treatment with BTK inhibitor for at least 3 months; prior treatment with single-agent rituximab is permitted if the last dose was administered more than 1 year ago
4. Have at least a 1-year life expectancy
5. Have a history of varicella (chickenpox) OR lived in the US or any endemic country for >30 years

Exclusion Criteria

1. Known hypersensitivity to a vaccine component
2. Herpes zoster reactivation within the past year
3. 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
4. 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
5. Are unable to give informed consent;
6. An absolute lymphocyte count greater than 20,000 x 10e9/L
7. Receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor
8. Rituximab treatment less than one year prior to study start
9. Prior chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified