drugset / Trial / NCT02518555

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT02518555

Phase 2 Completed 42 enrolled Jennifer Woyach Pharmacyclics LLC. · collab
RandomizedParallel-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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