NCT02518555

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

Early Intervention Trial of Ibrutinib for Patients With Asymptomatic, High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Jennifer Woyach · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the 2-year progression-free survival of asymptomatic, high-risk genomic chronic lymphocytic leukemia (CLL) patients treated with ibrutinib. SECONDARY OBJECTIVES: I. To determine whether concurrent administration of ibrutinib with 2 doses of the pneumococcal vaccine (pneumococcal 13-valent conjugate vaccine) does not negatively impact the immune response compared to those who receive the pneumococcal vaccination with sequential therapy. II. To determine the safety and toxicity associated with administering ibrutinib to asymptomatic, high-risk genomic CLL patients. III. To determine the response pattern (complete response \[CR\] minimal residual disease \[MRD\]-, CR, partial response \[PR\], PR with lymphocytosis, stable disease \[SD\]) in asymptomatic, genomic high-risk patients treated with ibrutinib. VI. To determine changes in the stress, anxiety and depressive symptoms, and related quality of life indicators from patients treated with ibrutinib.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed	Given IM
DRUG	Ibrutinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
BIOLOGICAL	Pneumococcal 13-valent Conjugate Vaccine	Given IM
OTHER	Quality-of-Life Assessment	Ancillary studies
BIOLOGICAL	Trivalent Influenza Vaccine	Given IM

Timeline

• Start date: 2016-01-12
• Primary completion: 2025-12-15
• Completion: 2026-01-05
• First posted: 2015-08-10
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study