Serologic response to a new recombinant, adjuvanted herpes zoster vaccine in patients with chronic lymphocytic leukemia and Waldenstrom macroglobulinemia treated with first-line BTK inhibitors

niversity of Rochester0 个研究点目标入组 32 人开始时间: 2023年11月16日最近更新: 2023年11月28日

适应症

试验速览

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

•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

•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

发起方

niversity of Rochester