Study on Ibrutinib and Vaccine Therapy for Patients with Asymptomatic, High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: Jennifer Woyach

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02518555

Provider View

This clinical trial is exploring how well the drug ibrutinib works when combined with vaccines to treat patients with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not show symptoms. The study aims to see if this combination can better control the disease.

Patient Parameters

Program Overview

The purpose of this study is to test if ibrutinib, a drug that may stop cancer cells from growing, works well with certain vaccines to treat patients with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not have symptoms. The vaccines used in this study are designed to help the body build a strong immune response to fight cancer cells. Researchers hope that combining ibrutinib with these vaccines will be a more effective treatment for CLL or SLL.

Description

The main goal of this study is to see if patients with high-risk chronic lymphocytic leukemia (CLL) who do not have symptoms can live without their disease getting worse for at least two years when treated with ibrutinib.

Other goals include:

  • Checking if taking ibrutinib with two doses of a pneumococcal vaccine affects the immune response compared to taking the vaccine separately.
  • Evaluating the safety and side effects of ibrutinib in these patients.
  • Observing how patients respond to ibrutinib, including complete or partial responses and stable disease.
  • Assessing changes in stress, anxiety, depression, and quality of life in patients taking ibrutinib.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Cancer cells must show certain high-risk genetic features, such as specific deletions or mutations.
  • No previous treatment for CLL/SLL, including chemotherapy or radiotherapy.
  • Expected to live for more than 24 months.
  • Good overall health with a performance status score of 0 to 2.
  • Normal liver and kidney function based on specific blood tests.
  • Able to swallow capsules and have no significant digestive issues.
  • Women must not be able to become pregnant or must have a negative pregnancy test.
  • Agree to use effective birth control during the study and for 30 days after the last dose.

Exclusion Criteria

  • Need for treatment due to symptoms like enlarged spleen or lymph nodes, anemia, or low platelet count.
  • Unintentional weight loss, severe fatigue, or fevers and night sweats without infection.
  • Previous treatment for CLL/SLL.
  • Use of corticosteroids within two weeks before the study, except for low-dose maintenance therapy.
  • Participation in another clinical trial or use of investigational drugs.
  • Allergic reactions to ibrutinib or any of the vaccines used in the study.
  • Other cancers with a life expectancy of less than two years.
  • Uncontrolled illnesses or psychiatric conditions that affect study participation.
  • Significant heart disease or recent heart attack.
  • Use of certain medications that affect the immune system or blood clotting.
  • Recent major surgery or active infections.
  • Pregnant or breastfeeding women.
  • Unable to understand the study or provide informed consent.

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