Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 vaccin...

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.

Tracking Information

NCT #
NCT02518555
Collaborators
Pharmacyclics LLC.
Investigators
Principal Investigator: Jennifer Woyach, MD Ohio State University Comprehensive Cancer Center