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Study of Ibrutinib for Treating Autoimmune Hemolytic Anemia in Patients with Chronic Lymphocytic Leukemia or Similar Conditions

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of a condition called Autoimmune Hemolytic Anemia (AIHA) in patients who have Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), as well as those with a condition similar to CLL known as CLL-like monoclonal B-cell lymphocytosis. The treatment being tested in this study is a medication called Ibrutinib, which is taken in the form of a hard capsule. Ibrutinib is a chemical substance that is designed to help manage these conditions.

The purpose of this study is to evaluate how effective Ibrutinib is in treating AIHA in patients with CLL, SLL, or CLL-like conditions. Participants in the study will take Ibrutinib orally, and the study will be conducted over a period of time with several cycles of treatment. Each cycle lasts 28 days, and the study will assess the response of AIHA after 6 cycles. Additionally, the study will look at the response after 3 and 12 cycles, as well as other factors like the duration of the response, the need for blood transfusions, and any side effects related to the treatment.

Throughout the study, researchers will also monitor the overall health and quality of life of the participants, as well as specific responses related to CLL. The study aims to provide valuable information on the effectiveness and safety of Ibrutinib for patients with these conditions, helping to improve treatment options in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be required to provide written informed consent. This ensures understanding and agreement to participate in the trial.

    Eligibility will be confirmed based on specific criteria, including a diagnosis of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or CLL-like monoclonal B-cell lymphocytosis (MBL).

  2. Step 2

    Treatment initiation

    The patient will begin treatment with ibrutinib, an oral medication. The dosage and frequency will be determined by the study protocol.

    The treatment is designed to assess the effectiveness of ibrutinib in treating autoimmune hemolytic anemia (AIHA) in patients with CLL/SLL or CLL-like MBL.

  3. Step 3

    Treatment cycles

    The treatment will be administered in cycles, each lasting 28 days. The primary endpoint is to assess AIHA overall response rate (ORR) after 6 cycles.

    Secondary assessments will occur after 3 and 12 cycles, evaluating various response rates and survival metrics.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient will undergo regular monitoring to assess the response to treatment and any potential side effects.

    Quality of life and other health parameters will be evaluated at baseline and after 3, 6, and 12 cycles.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment cycles, the patient's response to ibrutinib will be thoroughly evaluated.

    The study aims to conclude by November 2026, with ongoing assessments to ensure patient safety and treatment efficacy.

Who can join the trial?

13 criteria

  • Must have a diagnosis of **Chronic Lymphocytic Leukemia (CLL)**, **Small Lymphocytic Lymphoma (SLL)**, or **CLL-like monoclonal B-cell lymphocytosis (MBL)** according to specific guidelines.
  • Men and women of childbearing potential, and their partners, must agree to use birth control methods until the end of the treatment.
  • Men must agree not to father a child or donate sperm while taking the study medication and for 3 months after finishing treatment.
  • Must be over 18 years old.
  • Must have active **Autoimmune Hemolytic Anemia (AIHA)**, which is a condition where the immune system destroys red blood cells. This includes:
    • AIHA that has returned after previous treatment with steroids, with or without another medication called rituximab.
    • AIHA that does not respond to steroids within 3 weeks.
    • AIHA that requires ongoing steroid treatment to maintain a response.
    • For patients with a specific type of AIHA that does not show certain test results, eligibility must be confirmed by the trial's main doctors.
    • Must sign a written consent form agreeing to participate, following international and local laws.
    • Must have a performance status of 2 or less on a scale used to assess how the disease affects daily living abilities.
    • Must have adequate kidney and liver function based on specific laboratory tests.
    • Must be able to swallow the study medication in pill form.
    • Women who can become pregnant must have a negative pregnancy test before starting the study medication and take monthly tests until the end of treatment.

Who cannot join the trial?

2 criteria

  • Patients who do not have **Chronic Lymphocytic Leukemia** (CLL) or **Small Lymphocytic Lymphoma** (SLL) cannot participate. These are types of blood cancers.
  • Patients who do not have **CLL-like monoclonal B-cell lymphocytosis** cannot participate. This is a condition where there are too many of a certain type of white blood cell in the blood.
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Investigated drugs

Ibrutinib is a medication used in this clinical trial to treat autoimmune hemolytic anemia in patients who have chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or CLL-like monoclonal B-cell lymphocytosis. It works by blocking a specific protein that helps cancer cells grow and survive, which may help to improve the condition of patients with these types of blood disorders.

What is already known about the treatment

Ibrutinib – Ibrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating autoimmune hemolytic anemia in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The main therapeutic indication for ibrutinib is its use in certain types of blood cancers, including CLL and SLL. At the molecular level, ibrutinib works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which plays a crucial role in the survival and proliferation of cancer cells. It is classified as a targeted therapy, specifically a BTK inhibitor, and is well-documented in medical literature for its role in treating various B-cell malignancies.

Investigated diseases

  • Chronic Lymphocytic Leukemia

    This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal lymphocytes, a type of white blood cell. It progresses slowly and may not cause symptoms for years. Over time, the abnormal cells can crowd out healthy blood cells, leading to issues like fatigue, infections, and swollen lymph nodes. As the disease advances, it can affect the body's ability to fight infections and may cause anemia or bleeding problems. The progression can vary greatly among individuals, with some experiencing rapid changes while others remain stable for long periods.

  • Small Lymphocytic Lymphoma

    This is a type of non-Hodgkin lymphoma that is closely related to chronic lymphocytic leukemia, involving the same type of cancerous lymphocytes. It primarily affects the lymph nodes rather than the blood and bone marrow. The disease progresses slowly, often without symptoms initially, but can lead to swollen lymph nodes, fatigue, and weight loss over time. As it advances, it may spread to other parts of the body, including the liver and spleen. The progression rate can vary, with some individuals experiencing a stable condition for years.

  • CLL-like Monoclonal B-cell Lymphocytosis

    This condition involves the presence of abnormal B-cells in the blood, similar to those seen in chronic lymphocytic leukemia, but in smaller numbers. It is often considered a precursor to CLL, though not all cases progress to leukemia. The condition typically does not cause symptoms and is often found incidentally during blood tests. Over time, it may remain stable or progress to CLL, but the progression is generally slow. Monitoring is usually required to track any changes in the condition.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509793-38-00Protocol codeCLL2323Estimated enrolment45 patientsSponsorFondazione Gimema Franco Mandelli Onlus

sourced from the EU Clinical Trials Register and site verification

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