Phase II Study of Ibrutinib and Short-Course Fludarabine for Untreated Chronic Lymphocytic Leukemia (CLL)

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Sponsor score: 0

ClinicalTrials ID:NCT02514083

This study is testing the safety and effectiveness of combining two drugs, ibrutinib and fludarabine, for patients with CLL who have not received any prior treatment. Ibrutinib is taken daily, while fludarabine is given during specific cycles. The study aims to see how well this combination works and how safe it is for patients.

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Program Overview

This clinical trial is exploring a new treatment approach for patients with chronic lymphocytic leukemia (CLL) who have not been treated before. The study combines two drugs: ibrutinib, which is taken daily, and fludarabine, which is given during specific treatment cycles. The main goals are to determine how effective this combination is in achieving a complete response after 24 weeks and to assess the safety by monitoring how many patients stop treatment due to side effects.

Description

Chronic lymphocytic leukemia (CLL) is a type of cancer that affects B cells, a kind of white blood cell. It often occurs in older adults. The exact cause of CLL is unknown, but it is known that CLL cells grow and survive by receiving signals through the B-cell receptor (BCR) and interacting with other cells, especially T cells.

Ibrutinib is a medication that can block these signals, helping to control the growth of CLL cells. It is already approved for use in certain CLL patients. However, ibrutinib alone may not eliminate all cancer cells, and over time, the cancer may become resistant. To improve treatment outcomes, this study combines ibrutinib with fludarabine, a drug that can kill both cancerous B cells and supportive T cells, potentially restoring a healthier immune system.

The study is for patients with CLL who have not received any previous treatment. Ibrutinib will be taken daily until the disease progresses or side effects become too severe. Fludarabine will be administered during the third and fourth treatment cycles. The study will monitor the safety and effectiveness of this combination.

Eligibility Criteria

Inclusion Criteria

Men and women diagnosed with CLL or small lymphocytic lymphoma (SLL) based on specific medical tests.
Active disease with symptoms such as significant weight loss, extreme fatigue, persistent fever, night sweats, worsening anemia, or enlarged spleen or lymph nodes.
No previous treatment for CLL/SLL.
Good overall health with a performance status score of 0 to 2.
Adequate blood cell counts and organ function.
Agreement to use effective birth control during the study and for 90 days after the last dose if sexually active.
Willingness to participate in all study procedures and evaluations.
Ability to understand the study and provide informed consent.

Exclusion Criteria

Transformed CLL or other types of lymphoma.
Active autoimmune conditions affecting blood cells.
Known bleeding disorders.
Impaired liver or kidney function.
Serious medical conditions that could affect safety or treatment outcomes.
Current or recent use of other cancer treatments or experimental therapies.
Active infections like Hepatitis B, Hepatitis C, or HIV.
Pregnancy or breastfeeding, or unwillingness to use birth control.
Mental health or social issues that could affect participation.
Under 18 years old.
Allergies to study drugs.
Need for certain blood thinners.
Recent history of other cancers, unless treated and disease-free for over 2 years.
Digestive issues affecting drug absorption.
Recent stroke or major surgery.
Significant heart disease or recent heart events.
Use of certain medications that interact with study drugs.

Locations

FACILITY	ZIP	CITY	STATE
National Institutes of Health Clinical Center	20892	Bethesda	Maryland

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