Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Summary
This randomized phase II trial studies how well ibrutinib works when given together with vaccine therapies in treating patients without clinical signs or indications that raise the possibility of a particular disorder or dysfunction (asymptomatic) who have high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Vaccines, such as pneumococcal 13-valent conjugate vaccine, trivalent influenza vaccine, and diphtheria toxoid/tetanus toxoid/acellular pertussis vaccine adsorbed, may help the body build an effective immune response to kill cancer cells. Giving ibrutinib together with vaccine therapies may be a better treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Timeline
- Start
- 2016-01-12
- Primary completion
- 2025-12-15
- Completion
- 2026-01-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed | Vaccine | — | Intramuscular |
| Subject | Ibrutinib | Small molecule | — | Oral |
| Subject | Influenza Virus Vaccine | Vaccine | — | Intramuscular |
| Subject | Prevnar 13 | Vaccine | — | Intramuscular |